Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Breast Adenocarcinoma

In brief

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.

Key facts

Study ID

NCT00433511

Run by

National Cancer Institute (NCI)

People needed

4994

Starts

2007-11-02

Expected to finish

2027-02-20

Last updated by the study team

2026-05-29

Who can join

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

You may qualify if…

• Patients must have histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on at least one of the following criteria:
• For axillary lymph node positive disease:
• Involvement of at least one sentinel or axillary lymph node on routine histologic examination; patients with negative sentinel nodes and negative axillary nodes or involvement only demonstrated by immunohistochemistry are not eligible unless they meet one of the other eligibility criteria below
• NOTE: consider intramammary nodes as equivalent to axillary nodes for the purposes of eligibility and stratification
• For axillary lymph node negative disease:
• Estrogen receptor (ER) negative tumor >= 1 cm
• ER+ tumor >= 5 cm regardless of recurrence score
• ER+ tumor >= 1 cm but < 5 cm with a recurrence score >= 11 (patients enrolled in the TAILORx trial are eligible)
• NOTE: axillary dissection is strongly encouraged in patients with lymph node involvement identified on sentinel node biopsy
• Patients must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, breast conservation surgery and axillary dissection or breast conservation surgery and sentinel node biopsy
• NOTE: breast conservation surgery includes lumpectomy, partial mastectomy, and excisional biopsy
• Margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS); patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible
• Time from last surgery for breast cancer (breast conservation surgery, mastectomy, sentinel node biopsy, axillary dissection or re-excision of breast conservation surgery margins) to planned treatment start date must be > 28 days and =< 84 days
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Within =< 8 weeks prior to randomization: Absolute neutrophil count >= 1,000/mm\^3
• Within =< 8 weeks prior to randomization: Platelet count >= 100,000/mm\^3
• Within =< 8 weeks prior to randomization: Total bilirubin =< 1.5 mg/dL
• Within =< 8 weeks prior to randomization: Aspartate aminotransferase (AST) =< 2 times upper limit of normal(ULN)
• Within =< 8 weeks prior to randomization: Serum creatinine =< 1.5 mg/dL
• Within =< 8 weeks prior to randomization: Urine protein:creatinine ratio < 1.0 or 24-hour protein
• Within =< 8 weeks prior to randomization: Partial thromboplastin time (PTT) =< 1.5 times ULN
• Within =< 8 weeks prior to randomization: Left ventricle ejection fraction (LVEF) >= institutional limits of normal by multigated acquisition scan (MUGA) or echocardiogram (ECHO)
• Patients who have undergone breast conservation surgery must receive radiation; prior to randomization, the investigator must specify the planned radiation technique:
• Whole breast radiation (WBRT) after chemotherapy
• Accelerated partial breast radiation (APBI) after chemotherapy

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Providence Hospital — Mobile, Alabama, United States
• Alaska Regional Hospital — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Virginia G Piper Cancer Care-Del Camino — Scottsdale, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• PCR Oncology — Arroyo Grande, 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
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Washington Hospital — Fremont, California, United States
• California Cancer Associates for Research and Excellence (cCare) — Fresno, California, United States
• Glendale Memorial Hospital and Health Center — Glendale, California, United States
• Marin Cancer Care Inc — Greenbrae, California, United States
• Marin General Hospital — Greenbrae, California, United States
• Northeast Alabama Regional Medical Center — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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