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Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01069796
Enrollment
64
Registered
2010-02-17
Start date
2010-04-30
Completion date
2014-06-30
Last updated
2016-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple Negative Metastatic Breast Cancer

Keywords

triple negative, metastatic, breast cancer, First line chemotherapy

Brief summary

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).

Interventions

DRUGPaclitaxel

80 mg/m² weekly

DRUGBevacizumab

10 mg/kg d1 d15

DRUGCapecitabine

800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 & 3

Sponsors

ARCAGY/ GINECO GROUP
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
objective response rate36 months for recrutment and 30 months for follow up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026