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

July 27, 2012 updated by: National Cancer Institute, Naples

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
complete pathologic response rate

Secondary Outcome Measures

Outcome Measure
toxicity of neoadjuvant treatment
predictive ability of noninvasive diagnostic methods for results of neoadjuvant treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimate)

February 12, 2007

Study Record Updates

Last Update Posted (Estimate)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CETRA
  • EudraCT number: 2006-003993-85

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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