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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01007942
Other study ID # CRAD001W2301
Secondary ID 2008-008697-31
Status Completed
Phase Phase 3
First received November 2, 2009
Last updated October 13, 2015
Start date October 2009
Est. completion date June 2015

Study information

Verified date October 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.


Recruitment information / eligibility

Status Completed
Enrollment 570
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.

- HER2+ status defined as IHC 3+ staining or in situ hybridization positive

- Patients with resistance to trastuzumab

- Prior taxane therapy

- Patients with an ECOG performance status of 0 - 2

- Patients with measurable disease as per RECIST criteria

- Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;

- Patients must meet laboratory criteria defined in the study within 21 days prior to randomization

Exclusion Criteria:

- Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer

- More than three prior chemotherapy lines for advanced disease.

- Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed >8 weeks prior to randomization

- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus

- Peripheral neuropathy = grade 2 at randomization

- Active cardiac disease

- History of cardiac dysfunction

- Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer

- Known hypersensitivity to any study medication

- Breastfeeding or pregnant

Other protocol-defined inclusion/exclusion criteria may ap

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
everolimus, vinorelbine, trastuzumab

Placebo + vinorelbine + trastuzumab


Locations

Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site C A B A Buenos Aires
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Mar del Plata Buenos Aires
Argentina Novartis Investigative Site Posadas Misiones
Argentina Novartis Investigative Site Quilmes Buenos Aires
Argentina Novartis Investigative Site Rio Negro Viedma
Argentina Novartis Investigative Site Rosario Sante Fe
Argentina Novartis Investigative Site Tucuman
Australia Novartis Investigative Site East Bentleigh Victoria
Australia Novartis Investigative Site Hobart Tasmania
Australia Novartis Investigative Site Kogarah New South Wales
Australia Novartis Investigative Site South Brisbane Queensland
Australia Novartis Investigative Site Southport Queensland
Australia Novartis Investigative Site St. Leonards New South Wales
Belgium Novartis Investigative Site Brussel
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Liège
Belgium Novartis Investigative Site Luxembourg
Belgium Novartis Investigative Site Namur
Belgium Novartis Investigative Site Sint-Niklaas
China Novartis Investigative Site Beijing
China Novartis Investigative Site Beijing
China Novartis Investigative Site Guangzhou
China Novartis Investigative Site Hangzhou Zhejiang
China Novartis Investigative Site Shanghai Shanghai
China Novartis Investigative Site Shanghai
Czech Republic Novartis Investigative Site Novy Jicin
Czech Republic Novartis Investigative Site Olomouc
Czech Republic Novartis Investigative Site Prague 5
France Novartis Investigative Site Bayonne
France Novartis Investigative Site Besançon cedex
France Novartis Investigative Site Hyères
France Novartis Investigative Site La Chaussée St Victor
France Novartis Investigative Site La Roche sur Yon Cedex
France Novartis Investigative Site Nice Cedex 2
France Novartis Investigative Site Saint-Brieuc Cédex
France Novartis Investigative Site Villejuif Cedex
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Gerlingen
Germany Novartis Investigative Site Halle/'Saale
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Homburg
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Magdeburg
Germany Novartis Investigative Site Mainz
Germany Novartis Investigative Site Minden
Germany Novartis Investigative Site München
Germany Novartis Investigative Site Recklinghausen
Germany Novartis Investigative Site Velbert
Greece Novartis Investigative Site Athens, Neo Faliro
Greece Novartis Investigative Site Heraklion Crete GR
Greece Novartis Investigative Site Patra - RIO GR
Greece Novartis Investigative Site Thessaloniki GR
Greece Novartis Investigative Site Thessaloniki GR
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Debrecen
Hungary Novartis Investigative Site Gyor
Israel Novartis Investigative Site Jerusalem
Israel Novartis Investigative Site Petach Tikva
Israel Novartis Investigative Site Ramat Gan
Israel Novartis Investigative Site Tel-Aviv
Italy Novartis Investigative Site Catania CT
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Pavia PV
Italy Novartis Investigative Site Sondrio SO
Japan Novartis Investigative Site Bunkyo-ku Tokyo
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Kashiwa Chiba
Japan Novartis Investigative Site Koto Tokyo
Japan Novartis Investigative Site Kumamoto City Kumamoto
Japan Novartis Investigative Site Kyoto-city Kyoto
Japan Novartis Investigative Site Maebashi-city Gunma
Japan Novartis Investigative Site Nagoya Aichi
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Sapporo Hokkaido
Japan Novartis Investigative Site Suita-city Osaka
Japan Novartis Investigative Site Yokohama Kanagawa
Mexico Novartis Investigative Site Ciudad De Mexico Distrito Federal
Mexico Novartis Investigative Site León Guanajuato
Poland Novartis Investigative Site Lublin
Poland Novartis Investigative Site Warszawa
Singapore Novartis Investigative Site Singapore
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Kosice
Spain Novartis Investigative Site A Coruna Galicia
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Cordoba Andalucia
Spain Novartis Investigative Site Jaen Andalucia
Spain Novartis Investigative Site La Coruna Galicia
Spain Novartis Investigative Site La Laguna Las Palmas de Gran Canaria
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Majadanonda Madrid
Spain Novartis Investigative Site Sabadell Barcelona
Spain Novartis Investigative Site Sevilla Andalucia
Spain Novartis Investigative Site Valencia Comunidad Valenciana
Spain Novartis Investigative Site Zaragoza
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Bangkok
Turkey Novartis Investigative Site Ankara
Turkey Novartis Investigative Site Istanbul
Turkey Novartis Investigative Site Izmir
United Kingdom Novartis Investigative Site Bournemouth
United Kingdom Novartis Investigative Site Leeds
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Manchester
United Kingdom Novartis Investigative Site Plymouth
United Kingdom Novartis Investigative Site Surrey England
United Kingdom Novartis Investigative Site Truro Cornwall
United States Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2) Atlanta Georgia
United States Comprehensive Cancer Center - Boca Raton Deerfield Beach Boca Raton Florida
United States Comprehensive Cancer Center - Boca Raton Dept.of BocaRatonCompCanCtr Boca Raton Florida
United States Texas Cancer Center ( Medical City Dallas Hospital) Dept. of Texas Cancer Ctr. (2) Dallas Texas
United States Texas Oncology, P.A. Midtown Dallas Texas
United States Texas Oncology, P.A. Presbyterian Hospital (2) Dallas Texas
United States Texas Oncology, P.A. Texas Onc - Amarillo Dallas Texas
United States Texas Oncology, P.A. Texas Oncology - Sammons Dallas Texas
United States University of Texas Southwestern Medical Center University of TX SW Med Ctr(2) Dallas Texas
United States Duke University Medical Center Dept. of DUMC (2) Durham North Carolina
United States North Shore University Health System NSU Evanston Illinois
United States Virginia Cancer Specialists, PC Dept.ofFairfaxNo.VA (2) Fairfax Virginia
United States Florida Cancer Specialists DeptofFloridaCancerSpecialists Fort Myers Florida
United States The Jones Clinic Dept .of The Jones Clinic (3) Germantown Tennessee
United States St Vincent Hospital Green Bay Oncology Green Bay Wisconsin
United States Rocky Mountain Cancer Centers RMCC Greenwood Village Colorado
United States Memorial Hospital Memorial Cancer Institute Hollywood Florida
United States Baylor College of Medicine Baylor Houston Texas
United States University of Texas/MD Anderson Cancer Center Dept of MD Anderson (17) Houston Texas
United States University of California San Diego La Jolla - UCSD Moores Cancer La Jolla California
United States NYU Langone Arena Oncology Dept.ofArenaOncologyAssoc(2) Lake Success New York
United States Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4) Las Vegas Nevada
United States Nevada Cancer Institute Dept. of Nevada Cancer (3) Las Vegas Nevada
United States Longview Cancer Center Longview Cancer Center (2) Longview Texas
United States Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(6) Nashville Tennessee
United States Virginia Oncology Associates Dept. of VOA (2) Norfolk Virginia
United States University of Nebraska Medical Center Unv Nebraska Med Ctr (2) Omaha Nebraska
United States MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2) Orlando Florida
United States Kansas City Cancer Center KCCC- South (2) Overland Park Kansas
United States Maryland Oncology Hematology Owning Mills Maryland
United States University of Pittsburgh Cancer Institute DeptofMageeWomen'sHospital(2) Pittsburgh Pennsylvania
United States Northwest Cancer Specialists Tutlatin Portland Oregon
United States Utah Cancer Specialists Utah Cancer (2) Salt Lake City Utah
United States Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) San Antonio Texas
United States South Texas Oncology and Hematology, PA South Texas Oncology (2) San Antonio Texas
United States Swedish Cancer Institute Swedish Cancer Institute Seattle Washington
United States St. Louis University Cancer Center SLU Cancer Center St. Louis Missouri
United States Park Nicollet Institute Dept. of Park Nicollet St. Louis Park Minnesota
United States Overlook Hospital - Carol G Simon Cancer Center Carol G Simon Summit New Jersey
United States University of Arizona / Arizona Cancer Center AZ Onc Assoc Tucson Arizona
United States University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(3) Tucson Arizona
United States Tyler Cancer Center Dept.ofTylerCancerCtr. (2) Tyler Texas
United States Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3) Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  China,  Czech Republic,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Mexico,  Poland,  Singapore,  Slovakia,  Spain,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progressive-free survival (PFS), defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. Every 6 months No
Secondary Overall survival (OS), defined as the time from date of randomization to the date of death from any cause. Every 3 months No
Secondary Overall response rate (ORR) defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST Every 6 weeks No
Secondary Patient reported outcome (PRO) questionnaires Every 6 weeks No
Secondary Clinical benefit rate (CBR) defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Every 6 weeks No
Secondary Laboratory assessments (hematology, chemistry, coagulation), AEs graded by CTCAE version 3.0 or equivalent Continuous until 28 days after the last dose of study drug Yes
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