Clinical trial · Interventional
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
A Phase II Study of Bevacizumab With Docetaxel and Capecitabine in the Neoadjuvant Setting for Breast Cancer Patients
NCT02005549CI-TRIAL-00015067completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab [Avastin] | Drug | Bevacizumab | ALIAS |
| capecitabine [Xeloda] | Drug | Capecitabine | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Therapy
- interventionNames
- Drug: bevacizumab [Avastin]
- Drug: docetaxel
- Drug: capecitabine [Xeloda]
Primary outcomes (1)
- measure
- Percentage of Participants With Pathological Complete Response (pCR)
- timeFrame
- Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
- description
- pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.
Secondary outcomes (2)
- measure
- Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.