VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer

This study is currently recruiting participants.

Verified by National Cancer Institute, Naples, February 2009

First Received: February 5, 2007 Last Updated: February 3, 2009 History of Changes

Sponsored by:	National Cancer Institute, Naples
Information provided by:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT00431704

Purpose

The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: vinorelbine Drug: carboplatin Drug: trastuzumab	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Vinorelbine Vinorelbine tartrate Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study

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

Primary Outcome Measures:

objective response rate
toxicity

Secondary Outcome Measures:

time to progression
overall survival

Estimated Enrollment:	39
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Detailed Description:

The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. Early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. In this phase II single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological or cytological diagnosis of breast cancer
Stage IV disease
None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted)
Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)
ECOG Performance Status 0-2
Age >18 and < 75 years
Left Ventricular Ejection Fraction (LVEF) >50%
Life expectancy >3 months
Signed informed consent

Exclusion Criteria:

Absence of measurable or evaluable disease
Life expectancy < 3 months
ECOG performance status > 2
History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ).
Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted)
Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dl
Creatinine > 1.5 x the upper normal limits
GOT and/or GPT > 2.5 x the upper normal limits and/or Bilirubin > 1.5 x the upper normal limits in absence of hepatic metastases
GOT and/or GPT > 5 x the upper normal limits and/or Bilirubin > 3 x the upper normal limits in presence of hepatic metastases
Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia
Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
Male gender
Pregnant or lactating women
Refusal or incapacity to provide informed consent
Inability to comply with follow up

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431704

Contacts

Contact: Francesco Perrone, M.D., Ph.D	+39 081 5903 ext 571	francesco.perrone@uosc.fondazionepascale.it
Contact: Alessandro Morabito, M.D.	+39 081 5903 ext 383	alessandro.morabito@uosc.fondazionepascale.it

Locations

Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C	Recruiting
Napoli, Italy, 80131
Principal Investigator: Andrea De Matteis, M.D.

Sponsors and Collaborators

National Cancer Institute, Naples

Investigators

Principal Investigator:	Andrea De Matteis, M.D.	NCI Naples, Division of Medical Oncology C
Principal Investigator:	Francesco Perrone, M.D., Ph.D.	NCI Naples, Clinical Trials Unit

More Information

No publications provided

Responsible Party:	NCI Naples ( Francesco Perrone )
Study ID Numbers:	VinCaT, EudraCT number: 2006-003994-28
Study First Received:	February 5, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00431704 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:

advanced
her-2 positive

Study placed in the following topic categories:

Vinorelbine
Skin Diseases
Trastuzumab
Breast Neoplasms

Carboplatin
Antineoplastic Agents, Phytogenic
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Vinorelbine
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Trastuzumab
Breast Neoplasms
Carboplatin
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009