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

NCT ID: NCT00434031

Last Updated: 2012-07-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

trastuzumab

Intervention Type: DRUG

liposomal doxorubicin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histological diagnosis of breast cancer
• Stage II-IIIB (T0-1-2-3-4-N+-M0 or T2-3-4-N0-M0; according to TNM AJCC classification, 2002)
• Hyperexpression of HER-2/neu (HercepTest 3+ or positive FISH test)
• Age> 18 e < 65 years
• Left ventricular ejection fraction (LVEF) > or = 55%
• ECOG Performance Status 0-2
• Neutrophils > or = 2000/mm³, platelets > or = 100.000/mm³ , hemoglobin > or = 10 g/dl), GOT, GPT and bilirubin < 1.25 x the upper normal limit, creatinine < 1.25 x the upper normal limit.
• Life expectancy > 3 months
• Signed informed consent.

Exclusion Criteria

• Any prior treatment for breast cancer
• Metastatic disease (M1)
• Performance status (ECOG) > or = 3
• Current malignancy or history of prior malignancy within past 10 years (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ of the uterine cervix)
• Neutrophils < 2.000/mm³ , platelets < 100.000/mm³ , hemoglobin < 10 g/dl.
• Creatinine > 1.25 x the upper normal limit
• GOT and/or GPT and/or bilirubin >1.25 x the upper normal limit.
• Concomitant conditions that, in the investigator's opinion, contraindicate the use of the drugs in the protocol.
• Congestive heart failure or history of congestive heart failure, unstable angina pectoris, myocardial infarction, clinically significant valvulopathy or uncontrolled arrhythmias
• Active infection
• Incapacity or refusal to provide informed consent.
• Inability to comply with follow up
• Pregnant or nursing females.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Principal Investigators

Andrea De Matteis, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Division of Medical Oncology C

Giuseppe D'Aiuto, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Division of Surgical Oncology A

Francesco Perrone, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Clinical Trials Unit

Locations

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Napoli, , Italy

Countries

Italy

Other Identifiers

EudraCT number: 2006-003993-85

Identifier Type: -

Identifier Source: secondary_id

CETRA

Identifier Type: -

Identifier Source: org_study_id