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

Metastatic Breast Cancer Clinical Trial

— VinCaT  

Official title:

Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00431704
• Other study ID #: VinCaT
• Secondary ID: 2006-003994-28
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2007
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• vinorelbine
25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients
• carboplatin
AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients
• trastuzumab
8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression

Locations

Country	Name	City	State
Italy	Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate		after 3 and 6 cycles of therapy
Primary	side effects		after every cycle of therapy
Secondary	time to progression		at 12 months, end of study
Secondary	overall survival		at 12 months, end of study