Clinical trial · Interventional
PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer
An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was put on hold then out of Medical Plan therefore cancelled
Summary
Brief summary (as posted)
This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab [Avastin] | Drug | Bevacizumab | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: bevacizumab [Avastin]
- Drug: docetaxel
Primary outcomes (1)
- measure
- Response rate, median progression free survival, overall survival
- timeFrame
- Event driven
Secondary outcomes (1)
- measure
- Adverse events
- timeFrame
- Throughout study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * male and female patients, \>=18 years of age; * stage IV, HER2 negative metastatic breast cancer; * candidate for taxane-based therapy; * ECOG performance status 0-2. Exclusion Criteria: * prior chemotherapy for metastatic breast cancer; * concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years; * suspicion of CNS metastasis; * clinically significant cardiovascular disease.
References
Publications (0)
Data not yet available