Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer

Completed · Phase 3

Conditions studied: Invasive Breast Carcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v6, Stage IV Breast Cancer AJCC v6 and v7

In brief

This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.

Key facts

Study ID: NCT00601900
Run by: National Cancer Institute (NCI)
People needed: 394
Starts: 2008-09-24
Expected to finish: 2025-05-01
Last updated by the study team: 2025-05-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting
Stage IV disease or stage IIIB disease (using American Joint Committee on Cancer [AJCC] criteria, 6th edition) not amenable to local therapy
Patients may not have a "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
Tumors (from either primary or metastatic sites) must express estrogen receptor (ER) and/or progesterone receptor (PgR) in >= 1% of cells will be considered positive
Postmenopausal women are eligible for this trial; before study registration, menopausal status must be defined according to the criteria below:
Age >= 55 years and one year or more of amenorrhea
Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml
For women age < 55 with prior hysterectomy but intact ovaries, with an estradiol assay < 20 pg/ml
Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration)
Ovarian suppression on a luteinizing hormone-releasing hormone (LH-RH) agonist
Premenopausal women who do not meet the postmenopausal criteria above are also eligible, but are required to undergo ovarian suppression; this can be initiated any time prior to or on day 1 of protocol therapy, regardless of chosen endocrine therapy, and will continue for the duration of protocol therapy
Patients must have measurable or non-measurable disease by RECIST criteria, with radiologic scans within 28 days of study registration
Measurable disease: lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed tomography (CT) scan
Non-measurable disease: all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly non-measurable lesions
Lesions that are considered non-measurable include the following:
Bone lesions
Leptomeningeal disease
Ascites
Pleural/pericardial effusion
Inflammatory breast disease
Abdominal masses that are not confirmed and followed by imaging techniques
Cystic lesions
Prior endocrine therapy is not required
Prior endocrine therapy in the metastatic setting is not permitted (unless tamoxifen or an aromatase inhibitor was initiated within 4 weeks prior to registration to facilitate enrollment of patients who recently started first-line endocrine therapy for metastatic breast cancer); if prior letrozole therapy was initiated within the past 4 weeks, the patients should remain on letrozole as the study therapy; patients who began therapy with tamoxifen, anastrozole or exemestane must switch to letrozole to be eligible to participate in this study
Prior endocrine therapy in the adjuvant setting is permitted; there is no time restriction for how long the patient must be on the adjuvant endocrine therapy, nor is there a time restriction for how long the patient needs to be off prior adjuvant endocrine therapy before beginning protocol therapy on 40503

Where it is running

Sparks Regional Medical Center — Fort Smith, Arkansas, United States
East Bay Medical Oncology Hematology Medical Associates-Antioch — Antioch, California, United States
Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
Mills-Peninsula Medical Center — Burlingame, California, United States
East Bay Radiation Oncology Center — Castro Valley, California, United States
Eden Hospital Medical Center — Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
Adventist Health Cancer Care Center Chico — Chico, California, United States
Community Cancer Institute — Clovis, California, United States
Bay Area Breast Surgeons Inc — Emeryville, California, United States
Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
Marin General Hospital — Greenbrae, California, United States
Los Angeles General Medical Center — Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
Contra Costa Regional Medical Center — Martinez, California, United States
Fremont - Rideout Cancer Center — Marysville, California, United States
Memorial Medical Center — Modesto, California, United States
El Camino Hospital — Mountain View, California, United States
Sutter Cancer Research Consortium — Novato, California, United States
Highland General Hospital — Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
Bay Area Tumor Institute — Oakland, California, United States
Hematology and Oncology Associates-Oakland — Oakland, California, United States
Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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