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

An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00774241

Enrollment

Registered

2008-10-17

Start date

2010-01-31

Completion date

2013-11-30

Last updated

2016-11-02

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

Conditions

Breast Cancer

Brief summary

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.

Interventions

DRUGbevacizumab [Avastin]

15mg/kg iv every 3 weeks

DRUGdocetaxel

75mg/m2 every 3 weeks for 18 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Response rate, median progression free survival, overall survival	Event driven

Secondary

Measure	Time frame
Adverse events	Throughout study

Outcome results

None listed

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