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

NCT ID: NCT00434031

Last Updated: 2012-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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locally advanced stage II stage IIIa stage IIIb HER-2 positive primary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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docetaxel

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

trastuzumab

Intervention Type DRUG

liposomal doxorubicin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Naples

OTHER

Sponsor Role lead

Principal Investigators

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Andrea De Matteis, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Division of Medical Oncology C

Giuseppe D'Aiuto, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Division of Surgical Oncology A

Francesco Perrone, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Clinical Trials Unit

Locations

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Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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EudraCT number: 2006-003993-85

Identifier Type: -

Identifier Source: secondary_id

CETRA

Identifier Type: -

Identifier Source: org_study_id