Clinical trial · Interventional
Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer
Weekly Paclitaxel-carboplatin Plus Bevacizumab as First Line Therapy for Patients With Triple Negative (ER-,PR-,HER2-) Metastatic Breast Cancer. A Multicenter Phase I-II Study
NCT00691379CI-TRIAL-00024004completedPhase 1 / Phase 2ClinicalTrials.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 efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population
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 | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Paclitaxel/Carboplatin/Bevacizumab
- interventionNames
- Drug: Carboplatin
- Drug: Bevacizumab
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes (3)
- measure
- Toxicity profile
- timeFrame
- Toxicity assessment of each chemotherapy cycle
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed metastatic breast adenocarcinoma * No HER2 overexpression or gene amplification * Absent or low ER or PR expression * No previous therapy for metastatic breast cancer is allowed * Age 18-75 years * Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * Performance status (WHO) 0-2 * Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases) * adequate renal function (serum creatinine \<1.5 times the upper normal limit) * bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) * No radiation of measurable disease (except brain metastases) * No progressive brain metastases according to clinical or radiological criteria * No brain metastases without prior radiation therapy * Written informed consent Exclusion Criteria: * Active infection * History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * History of stroke * Anticoagulation therapy (except of low dose aspirin \<325mg) * Other invasive malignancy except nonmelanoma skin cancer * Psychiatric illness or social situation that would preclude study compliance * Pregnant or lactating women
References
Publications (1)
- DERIVEDSaloustros E, Nikolaou M, Kalbakis K, Polyzos A, Christofillakis C, Kentepozidis N, Pistamaltzian N, Kourousis C, Vamvakas L, Georgoulias V, Mavroudis D. Weekly Paclitaxel and Carboplatin Plus Bevacizumab as First-Line Treatment of Metastatic Triple-Negative Breast Cancer. A Multicenter Phase II Trial by the Hellenic Oncology Research Group. Clin Breast Cancer. 2018 Feb;18(1):88-94. doi: 10.1016/j.clbc.2017.10.013. Epub 2017 Oct 24. PMID 29153775