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

Breast Cancer Clinical Trial

— CETRA  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00434031
• Other study ID #: CETRA
• Secondary ID: EudraCT number:
• Status: Withdrawn
• Phase: Phase 2
• First received: February 9, 2007
• Last updated: July 27, 2012
• Start date: September 2007

Study information

• Verified date: July 2012
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel

• cyclophosphamide

• trastuzumab

• liposomal doxorubicin

Locations

Country	Name	City	State
Italy	Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete pathologic response rate
Secondary	toxicity of neoadjuvant treatment
Secondary	predictive ability of noninvasive diagnostic methods for results of neoadjuvant treatment