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Phase II randomized trial of combination therapy of paclitaxel and bevacizumab versus paclitaxel, capecitabine and bevacizumab as first-line treatment for locally recurrent or metastatic breast cancer patients with HER2/neu negative tumor

Recruiting
Conditions
ocally recurrent or metastatic breast cancer patients with HER2/neu negative tumor
Registration Number
NL-OMON20125
Lead Sponsor
VU University medical centerProf. E. Boven, MD, PhD, medical oncologistDe Boelelaan 11171081 HV AmsterdamPhone: 020-444 4336E-mail: e.boven@vumc.nltogether with:Borstkanker Onderzoek Groep(BOOG) Dr. A.E. van Leeuwen-Stok, research-managerP.O. Box 9236, 1006 AE AmsterdamPhone: 020-346 2547Fax: 020-346 2525E-mail: boog@ikca.nl
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
312
Inclusion Criteria

1. Patients with histologically or cytologically confirmed, HER2/neu-negative, pre- or postmenopausal adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to resection and/or radiotherapy with curative intent.

2. Documented ER/PR status

Exclusion Criteria

* Previous treatment

•Previous chemotherapy for locally recurrent or metastatic breast cancer

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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