PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer

Roche

Status and phase: Withdrawn; Phase 4

Conditions: Breast Cancer

Treatments: Drug: docetaxel; Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00774241

ML21343

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female patients, >=18 years of age;
• stage IV, HER2 negative metastatic breast cancer;
• candidate for taxane-based therapy;
• ECOG performance status 0-2.

Exclusion criteria

• prior chemotherapy for metastatic breast cancer;
• concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
• suspicion of CNS metastasis;
• clinically significant cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: docetaxel