Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer

Completed · Phase 2

Conditions studied: Breast Neoplasms

In brief

This is a phase II, open-label, multicenter, pilot study of the safety and efficacy of two Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with node positive or high risk node negative breast cancer. The primary objective of this study was to evaluate the cardiac safety, and the secondary objectives were to evaluate safety and toxicity of participants treated with bevacizumab ± trastuzumab administered with 2 different docetaxel-based combination regimens. This study was originally designed to also evaluate disease-free survival (DFS) and overall survival (OS); however, based on a protocol amendment, follow-up was shortened from 10 years to 2 years, and the efficacy endpoints of disease free survival and overall survival were deleted from the protocol.

Key facts

Study ID

NCT00446030

Run by

Sanofi

People needed

127

Starts

2007-03-01

Expected to finish

2010-08-01

Last updated by the study team

2012-06-26

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants who met the following criteria were eligible for this study:
• Woman aged 18 to 70 years, inclusive
• Had histologically proven breast cancer with the most recent surgery done for breast cancer up to 60 days prior to study registration
• Had definitive surgical treatment - either mastectomy, or breast conserving surgery with axillary lymph node dissection (or sentinel lymph node biopsy) for operable breast cancer (T1-3, clinical N0-1, and M0)
• Must have been either "lymph node positive" or "high risk lymph node negative"
• Were lymph node positive participants who had at least 1 axillary lymph node involved by breast cancer. (with lymph node metastasis >0.2 mm)
• Were high risk lymph node negative participants had no lymph node involvement and at least 1 of the following factors:
• tumor size >2 cm
• estrogen receptor (ER) and progesterone receptor (PR) status negative
• histologic and/or nuclear Grade 2/3
• age <35 years
• Were participants with the Human Epidermal growth factor Receptor 2 (HER2/neu) status (positive or negative) known at the time of signing the informed consent
• Had the estrogen and progesterone receptor status known prior to study registration
• Had Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Had normal cardiac function, confirmed by left ventricular ejection fraction (LVEF) or shortening fraction (echocardiography [ECHO] or multiple-gated acquisition [MUGA] scan respectively)
• Had the following hematology criteria confirmed within 2 weeks prior to study registration:
• Absolute neutrophil count (ANC) >1,500/microL
• Platelets >100,000/microL
• Hemoglobin ≥ 9 g/dL
• Met hepatic function evaluation criteria for bilirubin and AST levels within 2 weeks prior to study registration
• Had completed staging work-up within 35 days (within 1 year for mammography or breast magnetic resonance imaging (MRI) prior to study registration
• May have had MammoSite® brachytherapy radiation when performed immediately following surgery and prior to receiving chemotherapy. The balloon catheter must have been removed at least 28 days prior to the start of study treatment
• May have had bilateral, synchronous breast cancer provided one primary tumor met the staging criteria
• Women of child bearing potential must have had a negative pregnancy test within 14 days prior to day 1 cycle 1
• Had consented to using an effective, non-hormonal method of contraception while receiving study treatment and for at least six (6) months following the last dose of bevacizumab, and must have been advised not to breast feed for at least six (6) months following the last dose of bevacizumab.

You may not qualify if…

• Participants with the following criteria were excluded from this study:
• Had prior systemic anticancer therapy for invasive breast cancer (immunotherapy,hormonotherapy, chemotherapy)
• Had prior anthracycline therapy, taxoids, or platinum salts for any malignancy
• Had prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy
• Was pregnant or lactating
• Had pre-existing motor or sensory neurotoxicity of a severity >Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 3.0
• Had cardiac disease or risk for same as follows:
• Any documented myocardial infarction
• Angina pectoris that required the use of anti-anginal medication
• Any history of documented congestive heart failure
• Grade 3 or Grade 4 cardiac arrhythmia (NCI CTCAE, version 3.0)
• Clinically significant valvular heart disease
• Had cardiomegaly
• Had poorly controlled hypertension, i.e., diastolic greater than 100 mmHg. (Participants who were well controlled on medication were eligible)
• Were currently receiving medications administered for cardiac arrhythmia, angina or congestive heart failure (e.g., digitalis, beta-blockers, calcium channel-blockers), that alter cardiac conduction, unless the medications were administered for other reasons (e.g., hypertension)
• Had other serious illness or medical conditions including
• History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that prohibited the understanding and giving of informed consent
• Active uncontrolled infection
• Active peptic ulcer
• Unstable diabetes mellitus
• with symptomatic, intrinsic lung disease resulting in dyspnoea at rest
• Clinically significant peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Urine protein:creatinine ratio >1.0 at screening
• History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, inflammatory bowel disease or other gastrointestinal condition increasing the risk of perforation within 6 months of beginning chemotherapy

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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