CompletedPhase 2

A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.

Spain72 participantsStarted 2007-12

Plain-language summary

This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * female patients, \>=18 years of age; * primary HER2-negative operable breast cancer; * tumor \>2cm in size; * ECOG performance status 0-1. Exclusion Criteria: * previous treatment for breast cancer; * metastatic disease; * current or recent (within 10 days of first dose of Avastin) use of aspirin (\>325mg/day) or full-dose anticoagulants for therapeutic purposes; * clinically significant cardiovascular disease.

What they're measuring

Percentage of Participants With Pathological Complete Response (pCR)

Timeframe: After Week 24 (surgery)

Trial details

NCT IDNCT00559754

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-09

Results submitted2014-05-16

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