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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601900 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen or letrozole together with bevacizumab to see how well it works compared with tamoxifen or letrozole alone in treating women with stage III or stage IV breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: bevacizumab Drug: letrozole Drug: placebo Drug: tamoxifen citrate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Endocrine Therapy in Combination With Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women With Hormone Receptor-Positive Advanced Breast Cancer |
Estimated Enrollment: | 502 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral endocrine therapy (tamoxifen citrate or letrozole) once daily and bevacizumab IV every 21 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: bevacizumab
IV every 21 days
Drug: letrozole
oral once daily
Drug: tamoxifen citrate
oral once daily
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Arm II: Active Comparator
Patients receive oral endocrine therapy (tamoxifen citrate or letrozole) once daily and a placebo IV every 21 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: letrozole
oral once daily
Drug: placebo
IV every 21 days
Drug: tamoxifen citrate
oral once daily
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to planned endocrine therapy (letrozole vs tamoxifen), disease measurability (no vs yes), and disease-free interval from initial diagnosis to first progression (≤ 24 months vs > 24 months). Patients are randomized to 1 of 2 treatment arms.
After completion of study therapy, patients are followed every 6 months for the first 2 years, then annually for up to 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting
Must have measurable or nonmeasurable disease by RECIST criteria, with radiologic scans (CT scan of the chest/abdomen)
Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly nonmeasurable lesions, including any of the following:
Baseline bone scans required for all patients for determination of metastatic bone disease
PATIENT CHARACTERISTICS:
Menopausal status: pre- or postmenopausal, meeting 1 of the following criteria:
Ovarian suppression on a luteinizing hormone-releasing hormone agonist (goserelin acetate or leuprolide acetate)
Premenopausal women must undergo ovarian suppression prior to beginning protocol therapy
Urinalysis ≤ 1+ protein
No "currently active" second malignancy other than nonmelanoma skin cancers
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior endocrine therapy in the metastatic setting unless tamoxifen or an aromatase inhibitor was initiated within 4 weeks prior to registration
Prior treatment with ovarian suppression is allowed in either the adjuvant or metastatic setting
Concurrent full dose anticoagulation therapy is allowed for the treatment of prior conditions such as venous thromboses or atrial fibrillation, but not for the treatment of prior arterial thrombotic events
Study Chair: | Maura N. Dickler, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000584091, CALGB-40503 |
Study First Received: | January 18, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00601900 |
Health Authority: | Unspecified |
stage IIIB breast cancer stage IV breast cancer recurrent breast cancer |
Skin Diseases Citric Acid Breast Neoplasms Letrozole |
Bevacizumab Tamoxifen Breast Diseases Recurrence |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Growth Substances Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Angiogenesis Inhibitors Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Aromatase Inhibitors |