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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00490139
Other study ID # EGF106708
Secondary ID CLAP016B23012006
Status Completed
Phase Phase 3
First received
Last updated
Start date May 16, 2007
Est. completion date July 1, 2021

Study information

Verified date July 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.


Other known NCT identifiers
  • NCT00609024

Recruitment information / eligibility

Status Completed
Enrollment 8382
Est. completion date July 1, 2021
Est. primary completion date December 6, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Eastern Cooperative Oncology Group (ECOG) performance status = 1; - Non-metastatic operable primary invasive adenocarcinoma of the breast fulfilling the following: 1. Histologically confirmed 2. Adequately excised (exceptions: patients who have 'non-resectable' deep margin invasion are eligible provided they have had or will receive radiotherapy encompassing the region concerned; patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumour bed); 3. Axilla dissected; sentinel node sampling is allowed provided that axillary dissection follows confirmation of a positive sentinel node; sentinel node sampling alone is NOT acceptable after neoadjuvant chemotherapy (in patients receiving neoadjuvant chemotherapy lymph node status will be considered unknown, regardless of the results of post-chemotherapy axillary dissection); 4. Axillary node positive patient OR node negative patient with a tumour greater than or equal to 1.0 cm in greatest diameter. For clarification, isolated tumour cells (ITC) are considered pN0 and micrometastases are considered pN1 - Known hormone receptor status (ER/PgR or ER alone) - For Designs 1 and 2: Patients must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or listed as an exception in Table 5 of the protocol. For Design 1: Randomization must be performed no longer than 12 weeks from day 1 of the last chemotherapy cycle after obtaining a post-chemotherapy LVEF = 50. Study treatment must start no more than 14 days after randomization For Design 2: Randomization must be performed no longer than 6 weeks from day 1 of the last anthracycline-containing chemotherapy cycle after obtaining a post-anthracycline chemotherapy LVEF = 50. Study treatment must start no more than 14 days after randomization and must be concurrent with taxanes. For Design 2B: Randomisation must be performed no longer than 8 weeks from definitive surgery. Non-anthracycline platinum containing regimen (docetaxel and carboplatin) and study treatment must start concomitantly and no more than 14 days after randomisation. - Baseline LVEF =50% measured by echocardiography or MUGA scan. For Design 1 and Design 2 - after completion of all anthracycline-based (neo-) adjuvant chemotherapy and prior to the targeted therapy(ies); for Design 2B - prior to targeted therapy(ies) and chemotherapy (docetaxel and carboplatin) - Over expression and/or amplification of HER2 in the invasive component of the primary tumour (in case of neoadjuvant treatment, tissue sample used for HER2 testing should be collected before neoadjuvant treatment starts), according to one of the following definitions [Wolff et al 2007] and confirmed by central laboratory prior to randomization: - 3+ over expression by IHC (> 30% of invasive tumour cells); - 2+ or 3+ (in 30% or less neoplastic cells) over expression by IHC AND in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification; - HER2 gene amplification by FISH/CISH ( > 6 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of > than 2.2.) Patients with a negative or equivocal overall result (FISH test ratio of = 2.2, = 6.0 HER2 gene copies per nucleus) and staining scores of 0, 1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial. Equivocal local results may be submitted for a final determination by the central laboratory. - Completion of all necessary baseline laboratory and radiological investigations - Signed written informed consent (approved by an Independent Ethics Committee (IEC) and obtained prior to any study specific screening procedures). Exclusion Criteria: - History of any prior (ipsi- and/or contralateral) invasive breast carcinoma; - Past (less than 10 years) or current history of malignant neoplasms, except for curatively treated 1) basal and squamous cell carcinoma of the skin or 2) carcinoma in situ of the cervix. NOTE: Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy or systemic therapy (chemotherapy or endocrine) are eligible for the study. Patients with any prior diagnosis of breast cancer or melanoma, at any time, are excluded from this study. - Any clinically staged T4 tumour, including inflammatory breast cancer; - Bilateral tumours; - This exclusion criterion has been removed as of protocol amendment 1. NOTE: multifocal/multicentric tumours are permitted: - If the patient is node-negative: one of the lesions must be equal or greater than 1.0 cm (sum of the lesion diameters is not acceptable) AND must have positive HER2 status centrally-confirmed; - If patient is node-positive: lesion size does not matter BUT one of the lesions must have HER2 positivity centrally-confirmed. If several lesions are found to be HER2 positive locally, the largest lesion should be considered for central review. - Maximum cumulative dose of doxorubicin >360mg/m² or maximum cumulative dose of epirubicin >720mg/m² or any prior anthracyclines unrelated to the present breast cancer; - (Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support; - Any prior mediastinal irradiation except internal mammary node irradiation for the present breast cancer; - Patients with positive or suspicious internal mammary nodes identified by sentinel node technique which have not been irradiated or will not be irradiated, or patients with supraclavicular lymph node involvement (confirmed by fine needle aspirate or biopsy); - Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for breast cancer; - Concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer; - Concurrent anti-cancer treatment in another investigational trial with hormone therapy or immunotherapy unless approved by the Executive Committee: - Serious cardiac illness or medical conditions including but not confined to: History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <50%); High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled); Angina pectoris requiring antianginal medication; Clinically significant valvular heart disease; Evidence of transmural infarction on ECG; Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg); - Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness; - Any of the following abnormal laboratory tests immediately prior to randomization: serum total bilirubin >1.5 x upper limit of normal (ULN), in the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 X ULN) is allowed; alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) >2.5 x ULN; alkaline phosphatase (ALP) > 2.5 x ULN; serum creatinine >2.0 x ULN; total white blood cell count (WBC) <2.5 x 10^9/L; absolute neutrophil count <1.5 x 10^9/L; platelets <100 x 10^9/L. - Unresolved or unstable serious adverse events from prior adjuvant chemotherapy or radiotherapy; - Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication. Subjects with ulcerative colitis are also excluded; - Pregnant, lactating or women of childbearing potential without a negative pregnancy test - urine or serum - within 7 days prior to randomization, irrespective of the method of contraception used, including tubal ligation; - Women of childbearing potential and male participants with partners of child bearing potential, including women whose last menstrual period was <12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment (adequate contraceptive measures: intra-uterine device, barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not indicated in this patient population); - Concomitant use of CYP3A4 inhibitors or inducers.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lapatinib
Small molecule inhibitor
Biological:
Trastuzumab
Antibody

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Germany Novartis Investigative Site Reutlingen Baden-Wuerttemberg
Germany Novartis Investigative Site Rheinfelden Baden-Wuerttemberg
Germany Novartis Investigative Site Rodewisch Sachsen
Germany Novartis Investigative Site Rosenheim Bayern
Germany Novartis Investigative Site Rostock Mecklenburg-Vorpommern
Germany Novartis Investigative Site Rotenburg (Wuemme) Niedersachsen
Germany Novartis Investigative Site Roth Bayern
Germany Novartis Investigative Site Saarbruecken Saarland
Germany Novartis Investigative Site Schkeuditz Sachsen
Germany Novartis Investigative Site Schwaebisch Hall Baden-Wuerttemberg
Germany Novartis Investigative Site Schwandorf Bayern
Germany Novartis Investigative Site Schwerin Mecklenburg-Vorpommern
Germany Novartis Investigative Site Schwetzingen Baden-Wuerttemberg
Germany Novartis Investigative Site Sigmaringen Baden-Wuerttemberg
Germany Novartis Investigative Site Solingen Nordrhein-Westfalen
Germany Novartis Investigative Site Stade Niedersachsen
Germany Novartis Investigative Site Stadthagen Niedersachsen
Germany Novartis Investigative Site Stendal Sachsen-Anhalt
Germany Novartis Investigative Site Stralsund Mecklenburg-Vorpommern
Germany Novartis Investigative Site Stuttgart Baden-Wuerttemberg
Germany Novartis Investigative Site Stuttgart Baden-Wuerttemberg
Germany Novartis Investigative Site Torgau Sachsen
Germany Novartis Investigative Site Traunstein Bayern
Germany Novartis Investigative Site Trier Rheinland-Pfalz
Germany Novartis Investigative Site Troisdorf Nordrhein-Westfalen
Germany Novartis Investigative Site Tuebingen Baden-Wuerttemberg
Germany Novartis Investigative Site Tuttlingen Baden-Wuerttemberg
Germany Novartis Investigative Site Ulm Baden-Wuerttemberg
Germany Novartis Investigative Site Vechta Niedersachsen
Germany Novartis Investigative Site Velbert Nordrhein-Westfalen
Germany Novartis Investigative Site Villingen-Schwenningen Baden-Wuerttemberg
Germany Novartis Investigative Site Waldmuenchen Bayern
Germany Novartis Investigative Site Weiden Bayern
Germany Novartis Investigative Site Weissenfels Sachsen-Anhalt
Germany Novartis Investigative Site Wesel Nordrhein-Westfalen
Germany Novartis Investigative Site Westerstede Niedersachsen
Germany Novartis Investigative Site Wiesbaden Hessen
Germany Novartis Investigative Site Wiesbaden Hessen
Germany Novartis Investigative Site Wiesbaden Hessen
Germany Novartis Investigative Site Witten Nordrhein-Westfalen
Germany Novartis Investigative Site Wuerselen Nordrhein-Westfalen
Germany Novartis Investigative Site Wuerzburg
Germany Novartis Investigative Site Wuppertal Nordrhein-Westfalen
Germany Novartis Investigative Site Wuppertal Nordrhein-Westfalen
Germany Novartis Investigative Site Wuppertal Nordrhein-Westfalen
Germany Novartis Investigative Site Zittau Sachsen
Germany Novartis Investigative Site Zwickau Sachsen
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Heraklion,Crete
Greece Novartis Investigative Site Patra
Greece Novartis Investigative Site Thessaloniki
Hong Kong Novartis Investigative Site Kowloon
Hong Kong Novartis Investigative Site Tuen Mun
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Gyor
Hungary Novartis Investigative Site Szeged
Hungary Novartis Investigative Site Szombathely
India Novartis Investigative Site Gurgaon
India Novartis Investigative Site Hyderabad
India Novartis Investigative Site Kolkatta (w.b.)
India Novartis Investigative Site Mangalore
India Novartis Investigative Site Mumbai
India Novartis Investigative Site Nagpur
India Novartis Investigative Site New Delhi
India Novartis Investigative Site New Delhi
India Novartis Investigative Site Trivandrum
Ireland Novartis Investigative Site Dublin
Ireland Novartis Investigative Site Dublin
Ireland Novartis Investigative Site Dublin
Ireland Novartis Investigative Site Galway
Ireland Novartis Investigative Site Limerick
Ireland Novartis Investigative Site Sligo
Ireland Novartis Investigative Site Tallaght, Dublin
Ireland Novartis Investigative Site Wilton, Cork
Israel Novartis Investigative Site Beer-Sheva
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Holon
Israel Novartis Investigative Site Jerusalem
Israel Novartis Investigative Site Kfar Saba
Israel Novartis Investigative Site Netanya
Israel Novartis Investigative Site Ramat Gan
Israel Novartis Investigative Site Rehovot
Israel Novartis Investigative Site Tel Aviv
Italy Novartis Investigative Site Alzano Lombardo (BG) Lombardia
Italy Novartis Investigative Site Asti Piemonte
Italy Novartis Investigative Site Avellino Campania
Italy Novartis Investigative Site Aviano (PN) Friuli-Venezia-Giulia
Italy Novartis Investigative Site Bergamo Lombardia
Italy Novartis Investigative Site Biella Piemonte
Italy Novartis Investigative Site Brescia Lombardia
Italy Novartis Investigative Site Brescia Lombardia
Italy Novartis Investigative Site Brindisi Puglia
Italy Novartis Investigative Site Candiolo (TO) Piemonte
Italy Novartis Investigative Site Carpi (MO) Emilia-Romagna
Italy Novartis Investigative Site Chieti
Italy Novartis Investigative Site Cosenza
Italy Novartis Investigative Site Cremona Lombardia
Italy Novartis Investigative Site Fano (Pesaro Urbino) Marche
Italy Novartis Investigative Site Fermo (AP) Marche
Italy Novartis Investigative Site Firenze Toscana
Italy Novartis Investigative Site Firenze Toscana
Italy Novartis Investigative Site Genova Liguria
Italy Novartis Investigative Site Lecce Puglia
Italy Novartis Investigative Site Lecco Lombardia
Italy Novartis Investigative Site Lido Di Camaiore (LU) Toscana
Italy Novartis Investigative Site Livorno Toscana
Italy Novartis Investigative Site Lugo (Ravenna) Emilia-Romagna
Italy Novartis Investigative Site Mantova Lombardia
Italy Novartis Investigative Site Meldola (FC) Emilia-Romagna
Italy Novartis Investigative Site Milano Lombardia
Italy Novartis Investigative Site Milano Lombardia
Italy Novartis Investigative Site Milano Lombardia
Italy Novartis Investigative Site Monserrato (CA) Sardegna
Italy Novartis Investigative Site Montepulciano (Siena Toscana
Italy Novartis Investigative Site Monza Lombardia
Italy Novartis Investigative Site Palermo Sicilia
Italy Novartis Investigative Site Palermo Sicilia
Italy Novartis Investigative Site Pavia Lombardia
Italy Novartis Investigative Site Pisa Toscana
Italy Novartis Investigative Site Poggibonsi (Siena) Toscana
Italy Novartis Investigative Site Potenza Basilicata
Italy Novartis Investigative Site Prato Toscana
Italy Novartis Investigative Site Ragusa Sicilia
Italy Novartis Investigative Site Ravenna Emilia-Romagna
Italy Novartis Investigative Site Rimini Emilia-Romagna
Italy Novartis Investigative Site Roma Lazio
Italy Novartis Investigative Site Roma Lazio
Italy Novartis Investigative Site Roma Lazio
Italy Novartis Investigative Site Rozzano (MI) Lombardia
Italy Novartis Investigative Site San Fermo Della Battaglia (Co) Lombardia
Italy Novartis Investigative Site Saronno (VA) Lombardia
Italy Novartis Investigative Site Sassari Sardegna
Italy Novartis Investigative Site Trento Trentino-Alto Adige
Italy Novartis Investigative Site Treviglio (BG) Lombardia
Italy Novartis Investigative Site Udine Friuli-Venezia-Giulia
Italy Novartis Investigative Site Varese Lombardia
Italy Novartis Investigative Site Viterbo Lazio
Japan Novartis Investigative Site Aichi
Japan Novartis Investigative Site Chiba
Japan Novartis Investigative Site Ehime
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Ibaraki
Japan Novartis Investigative Site Kanagawa
Japan Novartis Investigative Site Kyoto
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Saitama
Japan Novartis Investigative Site Tokyo
Japan Novartis Investigative Site Tokyo
Japan Novartis Investigative Site Tokyo
Japan Novartis Investigative Site Tokyo
Japan Novartis Investigative Site Tokyo
Korea, Republic of Novartis Investigative Site Gyeonggi-do
Korea, Republic of Novartis Investigative Site Incheon
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Suwon-si, Gyeonggi-do
Malaysia Novartis Investigative Site Kubang Kerian
Malaysia Novartis Investigative Site Sarawak
Mexico Novartis Investigative Site Chihuahua
Mexico Novartis Investigative Site Merida Yucatán
Mexico Novartis Investigative Site Mexico City
Mexico Novartis Investigative Site Mexico D.F.
Mexico Novartis Investigative Site Mexico DF
Mexico Novartis Investigative Site Toluca Estado De México
Netherlands Novartis Investigative Site Amersfoort
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Arnhem
Netherlands Novartis Investigative Site Blaricum
Netherlands Novartis Investigative Site Delft
Netherlands Novartis Investigative Site Den Haag
Netherlands Novartis Investigative Site Den Haag
Netherlands Novartis Investigative Site Eindhoven
Netherlands Novartis Investigative Site Gouda
Netherlands Novartis Investigative Site Hoofddorp
Netherlands Novartis Investigative Site Leeuwarden
Netherlands Novartis Investigative Site Leiden
Netherlands Novartis Investigative Site Leidschendam
Netherlands Novartis Investigative Site Purmerend
Netherlands Novartis Investigative Site Rotterdam
Netherlands Novartis Investigative Site Rotterdam
Netherlands Novartis Investigative Site Sittard-geleen
Netherlands Novartis Investigative Site Tilburg
Netherlands Novartis Investigative Site Utrecht
New Zealand Novartis Investigative Site Hamilton
New Zealand Novartis Investigative Site Palmerston North
New Zealand Novartis Investigative Site Wellington
Norway Novartis Investigative Site Forde
Norway Novartis Investigative Site Oslo
Norway Novartis Investigative Site Oslo
Norway Novartis Investigative Site Tromso
Pakistan Novartis Investigative Site Karachi
Pakistan Novartis Investigative Site Karachi
Pakistan Novartis Investigative Site Lahore
Pakistan Novartis Investigative Site Lahore
Pakistan Novartis Investigative Site Rawalpindi
Peru Novartis Investigative Site Callao
Peru Novartis Investigative Site Lima
Peru Novartis Investigative Site Lima
Peru Novartis Investigative Site Lima
Philippines Novartis Investigative Site Cebu
Philippines Novartis Investigative Site Quezon City
Philippines Novartis Investigative Site Sampaloc Manila
Philippines Novartis Investigative Site San Juan
Poland Novartis Investigative Site Bydgoszcz
Poland Novartis Investigative Site Elblag
Poland Novartis Investigative Site Gdansk
Poland Novartis Investigative Site Gdansk
Poland Novartis Investigative Site Gliwice
Poland Novartis Investigative Site Krakow
Poland Novartis Investigative Site Krakow
Poland Novartis Investigative Site Olsztyn
Poland Novartis Investigative Site Olsztyn
Poland Novartis Investigative Site Opole
Poland Novartis Investigative Site Rzeszow
Poland Novartis Investigative Site Szczecin
Poland Novartis Investigative Site Warszawa
Poland Novartis Investigative Site Wroclaw
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Bucuresti
Romania Novartis Investigative Site Cluj-Napoca
Romania Novartis Investigative Site Iasi
Russian Federation Novartis Investigative Site Arkhangelsk
Russian Federation Novartis Investigative Site Chelyabinsk
Russian Federation Novartis Investigative Site Irkutsk
Russian Federation Novartis Investigative Site Kazan
Russian Federation Novartis Investigative Site Kirov
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Novosibirsk
Russian Federation Novartis Investigative Site Omsk
Russian Federation Novartis Investigative Site Orenburg
Russian Federation Novartis Investigative Site Ryazan
Russian Federation Novartis Investigative Site Samara
Russian Federation Novartis Investigative Site St. Petersburg
Russian Federation Novartis Investigative Site St. Petersburg
Russian Federation Novartis Investigative Site Voronezh
Singapore Novartis Investigative Site Singapore
Singapore Novartis Investigative Site Singapore
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Kosice
Slovakia Novartis Investigative Site Poprad
Slovakia Novartis Investigative Site Rimavska Sobota
Slovakia Novartis Investigative Site Zilina
Slovenia Novartis Investigative Site Ljubljana
South Africa Novartis Investigative Site Capital Park
South Africa Novartis Investigative Site Groenkloof, Pretoria, 0001
South Africa Novartis Investigative Site Johannesburg
South Africa Novartis Investigative Site Observatory
South Africa Novartis Investigative Site Panorama
South Africa Novartis Investigative Site Parktown
South Africa Novartis Investigative Site Pretoria
South Africa Novartis Investigative Site Pretoria
South Africa Novartis Investigative Site Saxonwold, Johannesburg
Spain Novartis Investigative Site Alcoy/Alicante
Spain Novartis Investigative Site Barakaldo (Vizcaya)
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Burgos
Spain Novartis Investigative Site Cadiz
Spain Novartis Investigative Site Castellon
Spain Novartis Investigative Site Cordoba
Spain Novartis Investigative Site Coria
Spain Novartis Investigative Site Elda
Spain Novartis Investigative Site Granada
Spain Novartis Investigative Site Hospitalet de Llobregat (Barcelona)
Spain Novartis Investigative Site Huesca
Spain Novartis Investigative Site La Laguna (Santa Cruz De Tenerife)
Spain Novartis Investigative Site Lerida
Spain Novartis Investigative Site Lugo
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Malaga
Spain Novartis Investigative Site Mataro
Spain Novartis Investigative Site Mostoles (Madrid)
Spain Novartis Investigative Site Murcia
Spain Novartis Investigative Site Murcia
Spain Novartis Investigative Site Palma de Mallorca
Spain Novartis Investigative Site Palma de Mallorca
Spain Novartis Investigative Site Pamplona
Spain Novartis Investigative Site Salamanca
Spain Novartis Investigative Site San Sebastian
Spain Novartis Investigative Site Santander
Spain Novartis Investigative Site Santiago
Spain Novartis Investigative Site Segovia
Spain Novartis Investigative Site Sevilla
Spain Novartis Investigative Site Sevilla
Spain Novartis Investigative Site Tarrasa, Barcelona
Spain Novartis Investigative Site Toledo
Spain Novartis Investigative Site Valencia
Spain Novartis Investigative Site Valencia
Spain Novartis Investigative Site Zamora
Spain Novartis Investigative Site Zaragoza
Switzerland Novartis Investigative Site Aarau
Switzerland Novartis Investigative Site Basel
Switzerland Novartis Investigative Site Bellinzona
Switzerland Novartis Investigative Site Bern
Switzerland Novartis Investigative Site Chur
Switzerland Novartis Investigative Site Lausanne
Switzerland Novartis Investigative Site Locarno
Switzerland Novartis Investigative Site St Gallen
Switzerland Novartis Investigative Site Thun
Switzerland Novartis Investigative Site Zuerich
Switzerland Novartis Investigative Site Zurich
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site Taichung
Taiwan Novartis Investigative Site Tainan County
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taipei
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Chiangmai
Thailand Novartis Investigative Site Hatyai, Songkhla
Thailand Novartis Investigative Site Khon Kaen
Thailand Novartis Investigative Site Phitsanulok
Ukraine Novartis Investigative Site Chernivtsi
Ukraine Novartis Investigative Site Donetsk
Ukraine Novartis Investigative Site Ivano-Frankivsk
Ukraine Novartis Investigative Site Kharkiv
Ukraine Novartis Investigative Site Kyiv
Ukraine Novartis Investigative Site Lviv
Ukraine Novartis Investigative Site Simferopol
Ukraine Novartis Investigative Site Uzhgorod
Ukraine Novartis Investigative Site Uzhorod
United Kingdom Novartis Investigative Site Ashford
United Kingdom Novartis Investigative Site Blackpool
United Kingdom Novartis Investigative Site Bournemouth
United Kingdom Novartis Investigative Site Brighton
United Kingdom Novartis Investigative Site Canterbury Kent
United Kingdom Novartis Investigative Site Chelmsford Essex
United Kingdom Novartis Investigative Site Cheltenham
United Kingdom Novartis Investigative Site Cottingham
United Kingdom Novartis Investigative Site Dorchester
United Kingdom Novartis Investigative Site Edinburgh Midlothian
United Kingdom Novartis Investigative Site Epping Essex
United Kingdom Novartis Investigative Site Exeter
United Kingdom Novartis Investigative Site Grimsby
United Kingdom Novartis Investigative Site Guildford
United Kingdom Novartis Investigative Site Gwynedd
United Kingdom Novartis Investigative Site Headington, Oxford Oxfordshire
United Kingdom Novartis Investigative Site Ipswich
United Kingdom Novartis Investigative Site Lancaster
United Kingdom Novartis Investigative Site Leeds
United Kingdom Novartis Investigative Site Lindley, Huddersfield
United Kingdom Novartis Investigative Site Liverpool
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Maidstone
United Kingdom Novartis Investigative Site Manchester Lancashire
United Kingdom Novartis Investigative Site Margate
United Kingdom Novartis Investigative Site Newcastle upon Tyne
United Kingdom Novartis Investigative Site Northwood Middlesex
United Kingdom Novartis Investigative Site Nottingham Gloucestershire
United Kingdom Novartis Investigative Site Nottingham
United Kingdom Novartis Investigative Site Plymouth
United Kingdom Novartis Investigative Site Poole, Dorset
United Kingdom Novartis Investigative Site Portsmouth
United Kingdom Novartis Investigative Site Preston Lancashire
United Kingdom Novartis Investigative Site Prittlewell Chase Essex
United Kingdom Novartis Investigative Site Romford
United Kingdom Novartis Investigative Site Sheffield
United Kingdom Novartis Investigative Site Shrewsbury
United Kingdom Novartis Investigative Site Southport
United Kingdom Novartis Investigative Site St Helens
United Kingdom Novartis Investigative Site Stoke on Trent
United Kingdom Novartis Investigative Site Sutton
United Kingdom Novartis Investigative Site Swansea
United Kingdom Novartis Investigative Site Whitchurch, Cardiff
United Kingdom Novartis Investigative Site Worthing
United States Novartis Investigative Site 'Aiea Hawaii
United States Novartis Investigative Site Aberdeen South Dakota
United States Novartis Investigative Site Abilene Texas
United States Novartis Investigative Site Abington Pennsylvania
United States Novartis Investigative Site Adrian Michigan
United States Novartis Investigative Site Albert Lea Minnesota
United States Novartis Investigative Site Albuquerque New Mexico
United States Novartis Investigative Site Albuquerque New Mexico
United States Novartis Investigative Site Alexandria Minnesota
United States Novartis Investigative Site Alton Illinois
United States Novartis Investigative Site Amarillo Texas
United States Novartis Investigative Site Ames Iowa
United States Novartis Investigative Site Anchorage Alaska
United States Novartis Investigative Site Anderson South Carolina
United States Novartis Investigative Site Ann Arbor Michigan
United States Novartis Investigative Site Ann Arbor Michigan
United States Novartis Investigative Site Ann Arbor Michigan
United States Novartis Investigative Site Anthony Kansas
United States Novartis Investigative Site Athens Georgia
United States Novartis Investigative Site Atlanta Georgia
United States Novartis Investigative Site Atlanta Georgia
United States Novartis Investigative Site Auburn Washington
United States Novartis Investigative Site Augusta Georgia
United States Novartis Investigative Site Augusta Georgia
United States Novartis Investigative Site Aurora Colorado
United States Novartis Investigative Site Aurora Illinois
United States Novartis Investigative Site Austell Georgia
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Baton Rouge Louisiana
United States Novartis Investigative Site Baton Rouge Louisiana
United States Novartis Investigative Site Battle Creek Michigan
United States Novartis Investigative Site Beachwood Ohio
United States Novartis Investigative Site Beaumont Texas
United States Novartis Investigative Site Bedford Texas
United States Novartis Investigative Site Beech Grove Indiana
United States Novartis Investigative Site Bellefontaine Ohio
United States Novartis Investigative Site Bellingham Washington
United States Novartis Investigative Site Bemidji Minnesota
United States Novartis Investigative Site Berkeley California
United States Novartis Investigative Site Berlin Vermont
United States Novartis Investigative Site Berwyn Illinois
United States Novartis Investigative Site Bethesda Maryland
United States Novartis Investigative Site Bethlehem Pennsylvania
United States Novartis Investigative Site Bettendorf Iowa
United States Novartis Investigative Site Big Rapids Michigan
United States Novartis Investigative Site Billings Montana
United States Novartis Investigative Site Bismarck North Dakota
United States Novartis Investigative Site Bloomington Illinois
United States Novartis Investigative Site Boca Raton Florida
United States Novartis Investigative Site Boise Idaho
United States Novartis Investigative Site Boise Idaho
United States Novartis Investigative Site Bolivar Missouri
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Boulder Colorado
United States Novartis Investigative Site Bowling Green Ohio
United States Novartis Investigative Site Bozeman Montana
United States Novartis Investigative Site Bremerton Washington
United States Novartis Investigative Site Bronx New York
United States Novartis Investigative Site Bronx New York
United States Novartis Investigative Site Bronx New York
United States Novartis Investigative Site Bryn Mawr Pennsylvania
United States Novartis Investigative Site Buffalo New York
United States Novartis Investigative Site Burien Washington
United States Novartis Investigative Site Burlingame California
United States Novartis Investigative Site Burlington Massachusetts
United States Novartis Investigative Site Burlington Vermont
United States Novartis Investigative Site Burnsville Minnesota
United States Novartis Investigative Site Butler Pennsylvania
United States Novartis Investigative Site Butte Montana
United States Novartis Investigative Site Byron Center Michigan
United States Novartis Investigative Site Canton Illinois
United States Novartis Investigative Site Canton Ohio
United States Novartis Investigative Site Canton Ohio
United States Novartis Investigative Site Cape Girardeau Missouri
United States Novartis Investigative Site Cape Girardeau Missouri
United States Novartis Investigative Site Carthage Illinois
United States Novartis Investigative Site Casper Wyoming
United States Novartis Investigative Site Castro Valley California
United States Novartis Investigative Site Cedar Park Texas
United States Novartis Investigative Site Cedar Rapids Iowa
United States Novartis Investigative Site Cedar Rapids Iowa
United States Novartis Investigative Site Centralia Washington
United States Novartis Investigative Site Chanute Kansas
United States Novartis Investigative Site Chapel Hill North Carolina
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site Charleston West Virginia
United States Novartis Investigative Site Charlottesville Virginia
United States Novartis Investigative Site Chattanooga Tennessee
United States Novartis Investigative Site Chattanooga Tennessee
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Chillicothe Ohio
United States Novartis Investigative Site Chippewa Falls Wisconsin
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Cleveland Ohio
United States Novartis Investigative Site Cleveland Ohio
United States Novartis Investigative Site Clifton Springs New York
United States Novartis Investigative Site Clyde Ohio
United States Novartis Investigative Site Colorado Springs Colorado
United States Novartis Investigative Site Columbia Ohio
United States Novartis Investigative Site Columbia South Carolina
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Columbus Georgia
United States Novartis Investigative Site Concord New Hampshire
United States Novartis Investigative Site Coon Rapids Minnesota
United States Novartis Investigative Site Cooperstown New York
United States Novartis Investigative Site Coos Bay Oregon
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Danville Pennsylvania
United States Novartis Investigative Site Danville Virginia
United States Novartis Investigative Site Dayton Ohio
United States Novartis Investigative Site Dayton Ohio
United States Novartis Investigative Site Dayton Ohio
United States Novartis Investigative Site Dayton Ohio
United States Novartis Investigative Site Dayton Ohio
United States Novartis Investigative Site Dearborn Michigan
United States Novartis Investigative Site Decatur Georgia
United States Novartis Investigative Site Delaware Ohio
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Des Moines Iowa
United States Novartis Investigative Site Des Moines Iowa
United States Novartis Investigative Site Des Moines Iowa
United States Novartis Investigative Site Des Moines Iowa
United States Novartis Investigative Site Detroit Michigan
United States Novartis Investigative Site Detroit Michigan
United States Novartis Investigative Site Dodge City Kansas
United States Novartis Investigative Site Dover Delaware
United States Novartis Investigative Site Duarte California
United States Novartis Investigative Site Duluth Minnesota
United States Novartis Investigative Site East Syracuse New York
United States Novartis Investigative Site Easton Maryland
United States Novartis Investigative Site Eau Claire Wisconsin
United States Novartis Investigative Site Eau Claire Wisconsin
United States Novartis Investigative Site Edina Minnesota
United States Novartis Investigative Site Edwards Colorado
United States Novartis Investigative Site El Dorado Kansas
United States Novartis Investigative Site Elkhart Indiana
United States Novartis Investigative Site Elmhurst New York
United States Novartis Investigative Site Elyria Ohio
United States Novartis Investigative Site Englewood Colorado
United States Novartis Investigative Site Ephrata Pennsylvania
United States Novartis Investigative Site Escanaba Michigan
United States Novartis Investigative Site Eugene Oregon
United States Novartis Investigative Site Eureka Illinois
United States Novartis Investigative Site Evanston Illinois
United States Novartis Investigative Site Exeter New Hampshire
United States Novartis Investigative Site Fairbanks Alaska
United States Novartis Investigative Site Fairfield California
United States Novartis Investigative Site Fargo North Dakota
United States Novartis Investigative Site Fayetteville North Carolina
United States Novartis Investigative Site Federal Way Washington
United States Novartis Investigative Site Fergus Falls Minnesota
United States Novartis Investigative Site Findlay Ohio
United States Novartis Investigative Site Flint Michigan
United States Novartis Investigative Site Flint Michigan
United States Novartis Investigative Site Fort Collins Colorado
United States Novartis Investigative Site Fort Collins Colorado
United States Novartis Investigative Site Fort Gordon Georgia
United States Novartis Investigative Site Fort Lauderdale Florida
United States Novartis Investigative Site Fort Myers Florida
United States Novartis Investigative Site Fort Sam Houston Texas
United States Novartis Investigative Site Fort Scott Kansas
United States Novartis Investigative Site Fort Wayne Indiana
United States Novartis Investigative Site Fort Worth Texas
United States Novartis Investigative Site Franklin Tennessee
United States Novartis Investigative Site Franklin Ohio
United States Novartis Investigative Site Frederick Maryland
United States Novartis Investigative Site Fredericksburg Virginia
United States Novartis Investigative Site Fremont California
United States Novartis Investigative Site Fresno California
United States Novartis Investigative Site Fridley Minnesota
United States Novartis Investigative Site Gainesville Georgia
United States Novartis Investigative Site Galesburg Illinois
United States Novartis Investigative Site Gastonia North Carolina
United States Novartis Investigative Site Germantown Tennessee
United States Novartis Investigative Site Glendale California
United States Novartis Investigative Site Glenwood Springs Colorado
United States Novartis Investigative Site Gloucester Massachusetts
United States Novartis Investigative Site Goldsboro North Carolina
United States Novartis Investigative Site Grand Forks North Dakota
United States Novartis Investigative Site Grand Island Nebraska
United States Novartis Investigative Site Grand Junction Colorado
United States Novartis Investigative Site Grand Rapids Michigan
United States Novartis Investigative Site Great Falls Montana
United States Novartis Investigative Site Greeley Colorado
United States Novartis Investigative Site Green Bay Wisconsin
United States Novartis Investigative Site Green Bay Wisconsin
United States Novartis Investigative Site Greenbrae California
United States Novartis Investigative Site Greenville Ohio
United States Novartis Investigative Site Greenville South Carolina
United States Novartis Investigative Site Gresham Oregon
United States Novartis Investigative Site Hackensack New Jersey
United States Novartis Investigative Site Hagerstown Maryland
United States Novartis Investigative Site Hamilton New Jersey
United States Novartis Investigative Site Hampton Virginia
* Note: There are 1412 locations in all - only the first 1000 are shown.

Sponsors (5)

Lead Sponsor Collaborator
Novartis Pharmaceuticals Breast International Group, Canadian Cancer Trials Group, National Cancer Institute (NCI), North Central Cancer Treatment Group

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Pakistan,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free Survival (DFS) Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause. DFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years. From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)
Secondary Overall Survival (OS) Overall survival is defined as the time from randomization until death due to any cause. Overall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years. From randomization until death due to any cause (median follow-up of 4.5 years)
Secondary Time to Recurrence Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant). The percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years. IDMC=Independent Data Monitoring Committee. From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)
Secondary Time to Distant Recurrence Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence). The percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years. From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)
Secondary Time to Central Nervous System Recurrence Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence. Both brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years. From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)
Secondary DFS Ignoring Non-breast Second Primary Malignancies Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause. DFS was estimated using the Kaplan Meier method. The non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab). From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)
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