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

This study has been withdrawn prior to enrollment.
(lack of enrollment)
Sponsor:
Information provided by:
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00434031
First received: February 9, 2007
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: cyclophosphamide
Drug: trastuzumab
Drug: liposomal doxorubicin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

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

Enrollment: 0
Study Start Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434031

Locations
Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Andrea De Matteis, M.D. NCI Naples, Division of Medical Oncology C
Principal Investigator: Giuseppe D'Aiuto, M.D. NCI Naples, Division of Surgical Oncology A
Principal Investigator: Francesco Perrone, M.D., Ph.D. NCI Naples, Clinical Trials Unit
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00434031     History of Changes
Other Study ID Numbers: CETRA, EudraCT number: 2006-003993-85
Study First Received: February 9, 2007
Last Updated: July 27, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
locally advanced
stage II
stage IIIa
stage IIIb
HER-2 positive
primary

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Trastuzumab
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 20, 2014