search
Back to results

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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
docetaxel
cyclophosphamide
trastuzumab
liposomal doxorubicin
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring locally advanced, stage II, stage IIIa, stage IIIb, HER-2 positive, primary

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Outcomes

Primary Outcome Measures

complete pathologic response rate

Secondary Outcome Measures

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

Full Information

First Posted
February 9, 2007
Last Updated
July 27, 2012
Sponsor
National Cancer Institute, Naples
search

1. Study Identification

Unique Protocol Identification Number
NCT00434031
Brief Title
CETRA: Neoadjuvant Caelyx and Trastuzumab in Her-2 Positive Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
lack of enrollment
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
locally advanced, stage II, stage IIIa, stage IIIb, HER-2 positive, primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Intervention Type
Drug
Intervention Name(s)
liposomal doxorubicin
Primary Outcome Measure Information:
Title
complete pathologic response rate
Secondary Outcome Measure Information:
Title
toxicity of neoadjuvant treatment
Title
predictive ability of noninvasive diagnostic methods for results of neoadjuvant treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea De Matteis, M.D.
Organizational Affiliation
NCI Naples, Division of Medical Oncology C
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuseppe D'Aiuto, M.D.
Organizational Affiliation
NCI Naples, Division of Surgical Oncology A
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D.
Organizational Affiliation
NCI Naples, Clinical Trials Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs