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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01007942 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HER2/Neu Over-expressing Locally Advanced Breast Cancer Metastatic Breast Cancer |
Drug: everolimus, vinorelbine, trastuzumab Drug: vinorelbine + trastuzumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III, Double-blind, Placebo-controlled Multicenter Trial of Daily Everolimus in Combination With Trastuzumab and Vinorelbine, in Pretreated Women With HER2/Neu Over-expressing Locally Advanced or Metastatic Breast Cancer |
| Estimated Enrollment: | 572 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Everolimus + vinorelbine + trastuzumab | Drug: everolimus, vinorelbine, trastuzumab |
| Placebo Comparator: placebo + vinorelbine + trastuzumab | Drug: vinorelbine + trastuzumab |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may ap
Contacts and Locations| Contact: Novartis Pharmaceuticals | +1 800 340 6843 |
Show 182 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01007942 History of Changes |
| Other Study ID Numbers: | CRAD001W2301, EudraCT 2008-008697-31 |
| Study First Received: | November 2, 2009 |
| Last Updated: | November 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Metastatic breast cancer locally advanced breast cancer HER2/neu positive breast cancer HER2/neu over-expressing progressive-free survival (PFS) over survival (OS) bolero |
bolero 3 Breast cancer everolimus HER+ vinorelbine herceptin trastuzumab |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Everolimus Sirolimus Vinorelbine Trastuzumab Vinblastine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |