Clinical trial · Observational
Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer
Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy Plus Bevacizumab in Women With HER2-Negative Metastatic Breast Cancer. An Observational Study.
NCT01978977CI-TRIAL-00019366completedClinicalTrials.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)
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Avastin regimens
- description
- Patients who are going to receive chemotherapy plus Avastin (bevacizumab)
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events
- timeFrame
- Every 2 or 3 weeks up to 12 or 18 weeks
- description
- In this observational study investigators are going to assess standard schedules in which administration was every 2 or 3 weeks
Secondary outcomes (3)
- measure
- Number of Participants with Response Rate
- timeFrame
- Disease evaluation at Week 3 or at week 6
- description
- In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 or 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Age ≥18 years * Patients with histologically or cytologically confirmed, HER2-negative, metastatic Breast Cancer * No prior first line treatment for metastatic Breast Cancer * Previous hormonotherapy for metastatic Breast Cancer is allowed * One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria * ECOG performance status ≤2 * Adequate haematological, renal and hepatic function * Urine protein \<2+ (dipstick) * Life expectancy of ≥12 weeks Exclusion Criteria: * Previous first line treatment for metastatic colorectal cancer(progression \>12 months after the end of adjuvant treatment) * Previous radiotherapy to target lesions * Patients with brain metastases and/or cancerous meningitis * Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma * Patients participating in interventional clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.