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

Sponsored by:	National Cancer Institute, Naples
Information provided by:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT00434031

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Docetaxel Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

Estimated Enrollment:	30
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

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

Study ID Numbers:	CETRA, EudraCT number: 2006-003993-85
Study First Received:	February 9, 2007
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00434031
Health Authority:	Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:

locally advanced
stage II
stage IIIa

stage IIIb
HER-2 positive
primary

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Trastuzumab
Breast Neoplasms

Cyclophosphamide
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 13, 2009