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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.

Phase 3
18 Years
Open (Enrolling)
HER2/Neu Over-expressing Locally Advanced Breast Cancer, Metastatic Breast Cancer

Thank you

Trial Information

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.

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

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

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

Every 6 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

June 2013

Related Keywords:

  • HER2/Neu Over-expressing Locally Advanced Breast Cancer
  • Metastatic Breast Cancer
  • 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



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University of California San Diego La Jolla - UCSD Moores Cancer La Jolla, California  92093-0658
University of Nebraska Medical Center Unv Nebraska Med Ctr (2) Omaha, Nebraska  68198
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North Shore University Health System NSU Evanston, Illinois  60201
Overlook Hospital - Carol G Simon Cancer Center Carol G Simon Summit, New Jersey  07901
Texas Oncology, P.A. Presbyterian Hospital (2) Dallas, Texas  75246
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) San Antonio, Texas  78229
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Florida Cancer Specialists DeptofFloridaCancerSpecialists Fort Myers, Florida  33901
Memorial Hospital Memorial Cancer Institute Hollywood, Florida  33021
MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2) Orlando, Florida  32806
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Maryland Oncology Hematology Owning Mills, Maryland  21117,
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Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(6) Nashville, Tennessee  37203
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Texas Cancer Center ( Medical City Dallas Hospital) Dept. of Texas Cancer Ctr. (2) Dallas, Texas  75230
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