Protocol Title

A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens

Description

If a participant meets the eligibility criteria and agrees to take part, she will be randomly assigned to one of six treatment groups. She will have an equal chance of being in any of the six groups. Participants will receive treatment every 3 weeks for approximately 6 months before undergoing either a lumpectomy or a mastectomy. Participants on three of the treatment arms will receive treatment with bevacizumab every 3 weeks for an additional 10 doses.

Objectives

To determine whether adding capecitabine or gemcitabine to the standard treatment of docetaxel followed by doxorubicin and cyclophosphamide will increase the rate of pathologic complete response.

To determine if adding bevacizumab to these 3 treatments will increase the rate of pathologic complete response.

Eligibility

Patient is at least 18 years of age.

Patient’s diagnosis of invasive adenocarcinoma of the breast was made by core needle biopsy.

Patient’s tumor is palpable and at least 2.0 cm in size.

Patients of childbearing potential must have a negative pregnancy test and agree to use an accepted method of non-hormonal contraception

Patient must have adequate organ function and meet other guidelines for eligibility as specified by the protocol.

Contact

For the current eligibility status of and additional information about this clinical study, please contact Breastlink Clinical Research Group at 1-562-981-6101.

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