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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00674414 |
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more effective than giving trastuzumab alone in treating women with breast cancer.
PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how well they work compared to trastuzumab alone before surgery in treating patients with breast cancer that can be removed by surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: trastuzumab Drug: everolimus Procedure: therapeutic conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Phase II, Randomized, Multi-Center Study, Assessing Value of Adding RAD001 to Trastuzumab as Preoperative Therapy of HER-2 Positive Primary Breast Cancer Amenable to Surgery. |
Estimated Enrollment: | 120 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive trastuzumab (Herceptin®) IV once weekly for 6 weeks. Patients then undergo surgery.
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Biological: trastuzumab
Trastuzumab (Herceptin®) IV once weekly
Procedure: therapeutic conventional surgery
Patients undergo surgery
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Arm II: Experimental
Patients receive trastuzumab as in arm I and oral everolimus once daily for 6 weeks. Within 24 hours after completing everolimus, patients undergo surgery.
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Biological: trastuzumab
Trastuzumab (Herceptin®) IV once weekly
Drug: everolimus
Oral everolimus once daily
Procedure: therapeutic conventional surgery
Patients undergo surgery
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically for up to 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of invasive breast cancer
Candidate for breast-conserving surgery, as defined by both of the following:
HER2-positive primary tumor, defined as meeting either of the following criteria:
No inflammatory breast cancer or bilateral breast cancer
PATIENT CHARACTERISTICS:
No hypercholesterolemia/hypertriglyceridemia ≥ grade 3
No other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including any of the following:
PRIOR CONCURRENT THERAPY:
More than 5 days (from randomization) since prior and no concurrent strong inhibitors or inducers of the isoenzyme CYP3A, including any of the following
France | |
Centre Alexis Vautrin | Recruiting |
Vandoeuvre-les-Nancy, France, 54511 | |
Contact: Contact Person 33-3-8359-8461 | |
Centre Antoine Lacassagne | Recruiting |
Nice, France, 06189 | |
Contact: Contact Person 33-49-203-1114 | |
Centre Leon Berard | Recruiting |
Lyon, France, 69373 | |
Contact: Contact Person 33-4-78-78-26-54 | |
Centre Oscar Lambret | Recruiting |
Lille, France, 59020 | |
Contact: Contact Person 33-32-029-5943 | |
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Recruiting |
Marseille, France, 13273 | |
Contact: Contact Person 33-4-9122-3537 | |
Institut Curie Hopital | Recruiting |
Paris, France, 75248 | |
Contact: Contact Person 33-1-5310-2695 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Contact Person 33-1-4211-4371 | |
Centre Regional Rene Gauducheau | Recruiting |
Nantes-Saint Herblain, France, 44805 | |
Contact: Contact Person 33-2-4067-9977 m-campone@nantes.fnclcc.fr |
Principal Investigator: | Mario Campone, MD | Centre Regional Rene Gauducheau |
Study ID Numbers: | CDR0000595159, FRE-FNCLCC-GEP-04/0606 - RAD-H, EUDRACT-2007-004098-24, EU-20851 |
Study First Received: | May 6, 2008 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00674414 History of Changes |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer HER2-positive breast cancer |
Everolimus Immunologic Factors Skin Diseases Trastuzumab |
Breast Neoplasms Immunosuppressive Agents Breast Diseases |
Everolimus Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Trastuzumab Breast Diseases |