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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Trastuzumab

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.