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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Carboplatin; Trastuzumab; Vinblastine; Vinorelbine

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