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

National Cancer Institute, Naples

Status and phase

Withdrawn

Phase 2

Conditions

Breast Cancer

Treatments

Drug: trastuzumab

Drug: cyclophosphamide

Drug: docetaxel

Drug: liposomal doxorubicin

Study type

Interventional

Funder types

Other

Identifiers

NCT00434031

EudraCT number: 2006-003993-85

CETRA

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.