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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
N/A
Open (Enrolling)
Female
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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001W2301

NCT ID:

NCT01007942

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

Name

Location

Rocky Mountain Cancer Centers RMCC - Denver-Midtown Greenwood Village, Colorado  
Nevada Cancer Institute Dept. of Nevada Cancer (3) Las Vegas, Nevada  89135
Arena Oncology Associates, PC Dept.ofArenaOncologyAssoc(2) Lake Success, New York  11042
South Texas Oncology and Hematology, PA South Texas Oncology (2) San Antonio, Texas  78258
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
Tyler Cancer Center Dept.ofTylerCancerCtr. (2) Tyler, Texas  75702
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
University of Arizona / Arizona Cancer Center AZ Onc Assoc Tucson, Arizona  85724
University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(3) Tucson, Arizona  85724
Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3) Washington, District of Columbia  20007-2197
Comprehensive Cancer Center - Boca Raton Deerfield Beach Boca Raton, Florida  33248
Comprehensive Cancer Center - Boca Raton Dept.of BocaRatonCompCanCtr Boca Raton, Florida  33248
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
Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2) Atlanta, Georgia  30322
Kansas City Cancer Center KCCC- South (2) Overland Park, Kansas  66210
Maryland Oncology Hematology Owning Mills, Maryland  21117,
Park Nicollet Institute Dept. of Park Nicollet St. Louis Park, Minnesota  55416
St. Louis University Cancer Center SLU Cancer Center St. Louis, Missouri  63110
Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4) Las Vegas, Nevada  89109
Duke University Medical Center Dept. of DUMC (2) Durham, North Carolina  27710
Northwest Cancer Specialists Tutlatin Portland, Oregon  97210
University of Pittsburgh Cancer Institute DeptofMageeWomen'sHospital(2) Pittsburgh, Pennsylvania  15232
The Jones Clinic Dept .of The Jones Clinic (3) Germantown, Tennessee  38138
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(6) Nashville, Tennessee  37203
Texas Oncology, P.A. Midtown Dallas, Texas  75251
Texas Oncology, P.A. Texas Oncology - Sammons Dallas, Texas  75246
Texas Cancer Center ( Medical City Dallas Hospital) Dept. of Texas Cancer Ctr. (2) Dallas, Texas  75230
Texas Oncology, P.A. Texas Onc - Amarillo Dallas, Texas  75246
University of Texas Southwestern Medical Center University of TX SW Med Ctr(2) Dallas, Texas  75390-8852
MD Anderson Cancer Center/University of Texas Dept of MD Anderson (17) Houston, Texas  77030-4009
Baylor College of Medicine Baylor Houston, Texas  77030
Longview Cancer Center Longview Cancer Center (2) Longview, Texas  75601
Utah Cancer Specialists Utah Cancer (2) Salt Lake City, Utah  84103
Virginia Oncology Associates Dept. of VOA (2) Norfolk, Virginia  23502
Swedish Cancer Institute Swedish Cancer Institute Seattle, Washington  98104
St Vincent Hospital Green Bay Oncology Green Bay, Wisconsin  
Virginia Cancer Specialists, PC Dept.ofFairfaxNo.VA (2) Fairfax, Virginia  22031