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Spots Global Cancer Trial Database for CETRA: Neoadjuvant Caelyx and Trastuzumab in Her-2 Positive Breast Cancer

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Trial Identification

Brief Title: CETRA: Neoadjuvant Caelyx and Trastuzumab in Her-2 Positive Breast Cancer

Official Title: Neoadjuvant Therapy With Trastuzumab and Docetaxel Followed by Trastuzumab, Caelyx (Liposomal Doxorubicin) and Cyclophosphamide in Operable or Locally Advanced Her-2 Positive Breast Cancer

Study ID: NCT00434031

Conditions

Breast Cancer

Study Description

Brief Summary: The purpose of this study is to evaluate the rate of pathologic complete response when giving docetaxel and trastuzumab followed by caelyx (liposomal doxorubicin), cyclophosphamide and trastuzumab before surgery in treating women with operable or locally advanced HER-2 positive breast cancer.

Detailed Description: Chemotherapy in association with trastuzumab, a monoclonal antibody, given before surgery, has been shown to reduce tumor size and permit better resection of HER-2 positive breast cancers. This study will evaluate the activity of a neoadjuvant treatment with docetaxel and trastuzumab given every 3 weeks for 4 cycles, followed by the combination of caelyx, cyclophosphamide and trastuzumab every 3 weeks for 4 cycles. Patients will undergo breast cancer surgery 2-5 weeks after the completion of neoadjuvant therapy. Adjuvant therapy after surgery will be given according to existing guidelines, and will include an additional 10 cycles of trastuzumab.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli, , Italy

Contact Details

Name: Andrea De Matteis, M.D.

Affiliation: NCI Naples, Division of Medical Oncology C

Role: PRINCIPAL_INVESTIGATOR

Name: Giuseppe D'Aiuto, M.D.

Affiliation: NCI Naples, Division of Surgical Oncology A

Role: PRINCIPAL_INVESTIGATOR

Name: Francesco Perrone, M.D., Ph.D.

Affiliation: NCI Naples, Clinical Trials Unit

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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