Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer

Hellenic Oncology Research Group

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Drug: Carboplatin

Drug: Bevacizumab

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00691379

CT/08.02

Details and patient eligibility

About

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

Full description

Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative) does not respond to hormonal or biological therapy with trastuzumab. However, triple negative breast cancers are highly sensitive to chemotherapy. The combination of paclitaxel and carboplatin administered on a weekly basis is active and well tolerated. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Enrollment

46 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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