Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer

Breast Cancer Clinical Trial

— Lilac  

Official title:

A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 980 Compared With Trastuzumab in Subjects With HER2 Positive Early Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901146
• Other study ID #: 20120283
• Secondary ID: 2012-004319-29
• Status: Completed
• Phase: Phase 3
• Start date: April 29, 2013
• Est. completion date: January 27, 2017

Study information

• Verified date: February 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 725
• Est. completion date: January 27, 2017
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females = 18 years of age

• Histologically confirmed invasive breast cancer

• Planning for surgical resection of breast tumor and sentinel node or axillary lymph node resection

• Planning neoadjuvant chemotherapy

• HER2 positive disease

• Measurable disease in the breast after diagnostic biopsy, defined as longest diameter = 2.0 cm

• Known estrogen receptor (ER) and progesterone receptor (PR) hormone receptor status at study entry

• Normal bone marrow function

• Normal hepatic function

• Normal renal function

• Subjects must sign an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form before any study specific procedures

Inclusion Criteria for Randomization:

• Left ventricular ejection fraction (LVEF) of =55% by 2D echocardiogram

• Complete all 4 cycles of run-in chemotherapy

Exclusion Criteria:

• Bilateral breast cancer

• Presence of known metastases

• Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer

• Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

• Pre-existing clinically significant (= grade 2) peripheral neuropathy

• Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension

• Severe dyspnea at rest requiring supplementary oxygen therapy

• History of positivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV)

• Recent infection requiring a course of systemic anti-infectives that were completed = 14 days before enrollment (with the exception of uncomplicated urinary tract infection)

• Woman of childbearing potential who is pregnant or is breast feeding

• Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence [periodic abstinence (eg calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of the protocol specified treatment

• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study

• Other investigational procedures while participating in this study are excluded

• Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients

• Subject previously has enrolled and/or has been randomized in this study

• Subject likely to not be available to complete all protocol required study visits or procedures

• History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ABP 980
ABP 980 was administered at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.
• Trastuzumab
Trastuzumab was administered at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.
• Paclitaxel
Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care).

Procedure:
• Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection

Locations

Country	Name	City	State
Belarus	Research Site	Brest
Belarus	Research Site	Grodno
Belarus	Research Site	Minsk
Belarus	Research Site	Minsk
Brazil	Research Site	Ijuí	RIO Grande DO SUL
Brazil	Research Site	Jaú	SAO Paulo
Brazil	Research Site	Porto Alegre	RIO Grande DO SUL
Brazil	Research Site	Salvador	Bahia
Brazil	Research Site	Santo André	SAO Paulo
Brazil	Research Site	São Paulo	SAO Paulo
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Sofia	Sofiya
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Veliko Tarnovo	Veliko Turnovo
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Montréal	Quebec
Chile	Research Site	Santiago
Chile	Research Site	Temuco	Cautín
Germany	Research Site	Berlin
Germany	Research Site	Bonn	Nordrhein-westfalen
Germany	Research Site	Bottrop	Nordrhein-westfalen
Germany	Research Site	Frankfurt	Hessen
Germany	Research Site	Frankfurt am Main	Hessen
Germany	Research Site	Fürstenwalde	Brandenburg
Greece	Research Site	Athens	Attica
Greece	Research Site	Athens	Attica
Greece	Research Site	Heraklion	Crete
Greece	Research Site	Thessaloniki	Nea Efkarpia
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen	Hajdu-bihar
Hungary	Research Site	Nyíregyháza	Szabolcs-szatmar-bereg
Hungary	Research Site	Szekszárd	Tolna
Hungary	Research Site	Szolnok	Jasz-nagykun-szolnok
Italy	Research Site	Bari
Italy	Research Site	Milano
Italy	Research Site	Palermo
Italy	Research Site	Parma
Italy	Research Site	Piacenza
Italy	Research Site	San Fermo della Battaglia	Como
Italy	Research Site	Varese
Mexico	Research Site	Monterrey	Nuevo LEON
Mexico	Research Site	Queretaro
Mexico	Research Site	San Luis Potosí	SAN LUIS Potosi
Mexico	Research Site	Toluca, Estado De Mexico
Poland	Research Site	Bydgoszcz	Kujawsko-pomorskie
Poland	Research Site	Gdansk	Pomorskie
Poland	Research Site	Poznan	Wielkopolskie
Poland	Research Site	Poznan	Wielkopolskie
Poland	Research Site	Rybnik	Slaskie
Poland	Research Site	Warszawa	Lubelskie
Poland	Research Site	Warszawa	Mazowieckie
Poland	Research Site	Warszawa	Mazowieckie
Romania	Research Site	Brasov
Romania	Research Site	Cluj
Romania	Research Site	Cluj-Napoca	Cluj
Romania	Research Site	Ploiesti	Prahova
Romania	Research Site	Timisoara	Timis
Russian Federation	Research Site	Arkhangelsk	Primorskiy
Russian Federation	Research Site	Chelaybinsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow Region	Moscow
Russian Federation	Research Site	Nizhny Novgorod
Russian Federation	Research Site	Obninsk	Kaluzhskaya
Russian Federation	Research Site	Pyatigorsk
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saransk	Mordovia
Russian Federation	Research Site	Sochi
Russian Federation	Research Site	Yaroslavl	Yaroslavlr
Serbia	Research Site	Belgrade
Serbia	Research Site	Belgrade
Serbia	Research Site	Kragujevac
Serbia	Research Site	Nis
Serbia	Research Site	Sremska Kamenica
South Africa	Research Site	Cape Town	Western Cape
South Africa	Research Site	Cape Town	Western Cape
South Africa	Research Site	Durban	KwaZulu-Natal
South Africa	Research Site	Johannesburg	Gauteng
Spain	Research Site	A Coruña	LA Coruna
Spain	Research Site	Alcorcón	Madrid
Spain	Research Site	Barcelona
Spain	Research Site	Lérida	Lleida
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Sabadell	Barcelona
Ukraine	Research Site	Chernivtsi
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv	Kiev
Ukraine	Research Site	Lutsk	Volyn
Ukraine	Research Site	Lviv
Ukraine	Research Site	Uzhgorod	Transcarpathia
Ukraine	Research Site	Zaporizhzhya
United Kingdom	Research Site	Nottingham	England
United Kingdom	Research Site	Peterborough	England

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Actavis Inc.

Countries where clinical trial is conducted

Belarus,  Brazil,  Bulgaria,  Canada,  Chile,  Germany,  Greece,  Hungary,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Pathologic Complete Response	Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS).; Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.	3 to 7 weeks after the last dose of study drug in the neoadjuvant phase
Secondary	Percentage of Participants With a Pathologic Complete Response in Breast Tissue Only	Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue, regardless of residual ductal carcinoma in situ (DCIS).; Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.	3 to 7 weeks after the last dose of study drug in the neoadjuvant phase
Secondary	Percentage of Participants With a Pathologic Complete Response in Breast Tissue and Axillary Lymph Nodes and Absence of DCIS	Pathological complete response was defined as the absence of invasive tumor cells in the breast tissue and axillary lymph node(s) and absence of residual DCIS.; Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.	3 to 7 weeks after the last dose of study drug in the neoadjuvant phase

External Links

•   AmgenTrials clinical trials website