TerminatedPhase 2

Bevacizumab in Combination With Chemotherapy in the Neo-adjuvant Setting for HER2 (-) Breast Cancer

Stopped: Due to poor accrual

Greece34 participantsStarted 2011-10

Plain-language summary

Investigators propose to study the efficacy of Bevacizumab plus systemic chemotherapy prior to surgery in order to make a locally advanced tumor operable. Treatment is thus expected to induce a maximum tumor shrinkage within a short period (usually 3-6 months). In addition Bevacizumab (Avastin) is to be administered as early as possible during the disease stages. The primary aim of this study is to evaluate the preliminary antitumor activity in terms of pathological complete responses (pCR) of bevacizumab in combination with chemotherapy.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. bilateral Mammography (before enrolment)
✓. histology
✓. grading
✓. hormone-receptor-status
✓. HER2 status negative (is defined as FISH/CISH negative or IHC0 or IHC1+, or IHC2+ and FISH/CISH negative)
✓. Hematology: Neutrophils ≥ 1.5 x 109/l, Platelets ≥ 100 x 109/l, Hemoglobin\>11 g/dl
✓. Hepatic function: Total bilirubin \< 1 x ULN, SGOT and SGPT \< 1.5 x ULN, Alkaline phosphatases \< 1.5 x ULN. In case of abnormal values, the liver function tests have to be repeated within 3 days before study treatment.
✓. Renal function: Creatinine \< 1 x ULN

What they're measuring

Number of Patients with Complete Response

Timeframe: On week 8 and 16

Trial details

NCT IDNCT01985841

SponsorHellenic Oncology Research Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

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