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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00434031
Recruitment Status : Withdrawn (lack of enrollment)
First Posted : February 12, 2007
Last Update Posted : July 30, 2012
Information provided by:
National Cancer Institute, Naples

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Drug: cyclophosphamide Drug: trastuzumab Drug: liposomal doxorubicin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. complete pathologic response rate

Secondary Outcome Measures :
  1. toxicity of neoadjuvant treatment
  2. predictive ability of noninvasive diagnostic methods for results of neoadjuvant treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00434031

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Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131
Sponsors and Collaborators
National Cancer Institute, Naples
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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

Layout table for additonal information Identifier: NCT00434031     History of Changes
Other Study ID Numbers: CETRA
EudraCT number: 2006-003993-85
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological