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Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

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.

NCT01007942•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (161)

University of Arizona / Cancer Center AZ Onc Assoc

Tucson, Arizona, United States

University of Arizona / Cancer Center Deptof Uof A/Arizona Cancer(3)

Tucson, Arizona, United States

University of California San Diego - Moores Cancer Center La Jolla - UCSD Moores Cancer

La Jolla, California, United States

Rocky Mountain Cancer Centers RMCC

Greenwood Village, Colorado, United States

Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3)

Washington D.C., District of Columbia, 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

Florida Cancer Specialists DeptofFloridaCancerSpecialists

Fort Myers, Florida, United States

Memorial Hospital Memorial Cancer Institute

Hollywood, Florida, United States

MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)

Orlando, Florida, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

April 5, 2017

Enrollment

569

ACTUAL participants

Conditions

HER2/Neu Over-expressing Locally Advanced Breast CancerMetastatic Breast Cancer

Interventions

everolimus

DRUG

Placebo

DRUG

vinorelbine

DRUG

trastuzumab

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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