Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

ARCAGY/ GINECO GROUP

Status and phase: Terminated; Phase 2

Conditions: Triple Negative Metastatic Breast Cancer

Treatments: Drug: Capecitabine; Drug: Bevacizumab; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01069796

A-Taxel (GINECO BR108)

Details and patient eligibility

About

Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female histologically confirmed adenocarcinoma of the breast ER-, PR-, HER2- disease
• Measurable disease
• Patients may received prior radiotherapy as adjuvant treatment or/and metastatic disease provided that they have progressive disease at study entry

Exclusion criteria

• Prior chemotherapy for metastatic disease
• HER2 positive and/or hormonal receptor positive

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Association bevacizumab paclitaxel capecitabine breast cancer

Experimental group

Description:

* bevacizumab 10 mg/kg in IV, D1 and D15 * paclitaxel 80mg/m2 in IV, D1 to D8 and D15 * capecitabine 1600mg/m2/D, per os, D1 to D5, Weeks 1,2 and 3

Treatment:

Drug: Bevacizumab

Drug: Capecitabine

Drug: Paclitaxel