Preoperative Dose-dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab in Operable Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

Dose dense chemotherapy, which is the term for Adriamycin and Cyclophosphamide (AC) followed by Taxol chemotherapy given every two weeks, is the standard chemotherapy for the treatment of ER+ or PR+ breast cancer. In this trial, the standard chemotherapy is being combined with bevacizumab. Bevacizumab is an antibody which works differently from the way other chemotherapy drugs work. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors by binding to a substance found on cancer cells called VEGF (vascular endothelial growth factor). Bevacizumab is approved by the FDA for the treatment of colorectal cancer and lung cancer. However, it is not approved for the treatment of breast cancer. Another goal of this research is to determine whether we can develop a way to identify tumors that will respond well to this study treatment.

Key facts

Study ID

NCT00546156

Run by

Ian E. Krop, MD, PhD

People needed

104

Starts

2007-10-01

Expected to finish

2012-12-01

Last updated by the study team

2021-05-18

Who can join

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

You may qualify if…

• Documented primary invasive breast cancer by histologic assessment
• Tumors must express estrogen (ER) and/or progesterone receptors (PR) by standard immunohistochemical methods. Tumors must be negative for HER2. There must be sufficient sample for further protocol-specified immunohistochemical analysis
• Patients must have high risk ER+ or PR+ breast cancer as defined by criteria listed in protocol
• 18 year of age or older
• Performance status of 0 or 1 by ECOG criteria
• Use of an effective means of contraception in subjects of childbearing potential
• Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to starting therapy.
• Patients taking exogenous sex-steroid hormone treatments for any reason at the time of diagnosis must discontinue all hormonal treatments at least 2 weeks prior to enrollment
• Patients must have preoperative treatment within 60 days of initial diagnosis of breast cancer
• No other malignancy that requires on-going treatment
• Normal organ function as outlined in the protocol

You may not qualify if…

• Prior cytotoxic chemotherapy or radiation for the current breast cancer
• Patients with inflammatory breast cancer
• HER2 positive disease defined as HER2-amplified by FISH or IHC 3+. HER2 2+ must be negative by FISH
• Known metastatic (Stage IV) disease
• Other investigational agents within 4 weeks prior to the start of study treatment
• Life expectancy of less than 6 months
• Peripheral neuropathy greater than or equal to grade 2
• Inadequately controlled hypertension
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• NYHA grade II or greater congestive heart failure
• History of prior myocardial infarction
• History of unstable angina within 12 months prior to study enrollment
• Any history of stroke or transient ischemic attack at any time
• Known CNS disease
• Significant vascular disease
• Symptomatic peripheral vascular disease
• Evidence of significant bleeding within 6 months of study; any serious non-healing wound, skin ulcers, or bone fracture; any abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the past 6 months; any major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during course of study.
• Known HIV positive
• Unwilling to undergo pretreatment biopsy and consent to acquisition of archival tissue
• Pregnant of lactating
• Known hypersensitivity to any component of bevacizumab

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber at Faulkner Hospital — Boston, Massachusetts, United States
• New Hampshire Oncology-Hematology PA — Hooksett, New Hampshire, United States

Full record on ClinicalTrials.gov

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