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

NCT ID: NCT00431704

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vinorelbine, carboplatin, trastuzumab

Group Type: EXPERIMENTAL

vinorelbine

Intervention Type: DRUG

25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients

carboplatin

Intervention Type: DRUG

AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients

trastuzumab

Intervention Type: DRUG

8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression

Interventions

vinorelbine

25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients

Intervention Type: DRUG

carboplatin

AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients

Intervention Type: DRUG

trastuzumab

8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea De Matteis, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Division of Medical Oncology C

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

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Clinical Trials Unit

Locations

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Napoli, , Italy

Countries

Italy

Other Identifiers

2006-003994-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VinCaT

Identifier Type: -

Identifier Source: org_study_id