Phase 2
Completed N=18
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
Source: ClinicalTrials.gov NCT02005549 ↗Enrolled (actual)
18
Serious AEs
27.8%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With Pathological Complete Response (pCR) — 22.22 percentage of participants
Summary
This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pathological Complete Response (pCR) |
22.22 | — |
| SECONDARY Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR) |
72.22 | — |
| SECONDARY Percentage of Participants Undergoing Breast-Conserving Surgery |
83 | — |
Eligibility Criteria
Inclusion Criteria
- female patients, 18-70years of age;
- histologically-proven invasive breast cancer;
- no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
- no distant disease/secondary cancer.
Exclusion Criteria
- pregnant or lactating women;
- pre-operative local treatment for breast cancer;
- prior or concurrent systemic antitumor therapy;
- clinically significant cardiac disease.
Data sourced from ClinicalTrials.gov (NCT02005549). 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.