Phase 2
Completed N=214
Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer
Source: ClinicalTrials.gov NCT00365365 ↗Enrolled (actual)
214
Serious AEs
27.8%
Results posted
Sep 2012
Primary outcomePrimary: Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF) — 1; 3; 1 participants
Summary
This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants with node positive or high-risk node negative breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF) |
1; 3; 1 | — |
| SECONDARY Safety - Number of Participants With Adverse Events (AE) |
78; 75; 59; 23; 24; 12 | — |
| SECONDARY Disease-free Survival (DFS) Rate |
93.6; 95.9; 98.2; 87.1; 94.1; 96.3 | — |
Eligibility Criteria
The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Inclusion Criteria
- Women >/= 18 years of age.
- Histologically proven breast cancer with an interval between definitive breast surgery that includes axillary lymph node (LN) dissection or axillary nodal evaluation and study registration of 28 days after the date of definitive breast surgery and the participant must be recovered from any clinically significant toxicity thereof.)
- Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection (axillary lymph node evaluation can be either full axillary node dissection or sentinel LN evaluation followed by dissection if sentinel LN is positive) for operable breast cancer (pT1-4 [including inflammatory], pNO-3, and MO). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.
- Subjects must be either lymph node-positive (pN1-3) or lymph node-negative (pN0) with high-risk features as determined by Investigator.
- High-risk, lymph node-negative participants, (pN0) will be defined as subjects having invasive adenocarcinoma with either a negative sentinel node biopsy (pN0[sn]) OR negative lymph node dissection (pN0) disease AND tumor size > 2 cm or tumor size >/= 1 cm with at least one of the following factors:
- negative estrogen receptor (ER) and negative progesterone receptor (PR) status
- histologic and/or nuclear Grade 2-3; or
- age /= 1,500/μL
- Platelets >/= 100,000/μL
- Hemoglobin >/= 9 g/dL
- Hepatic function evaluation within 2 weeks prior to study entry:
- Total bilirubin 7 days following a minor surgical procedure. Chemotherapy may be given without bevacizumab in circumstances in which the participant has recovered sufficiently to receive chemotherapy but has not yet reached a 28 day time point at which bevacizumab could be administered.
Data sourced from ClinicalTrials.gov (NCT00365365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.