Metastatic Breast Cancer
Conditions
Keywords
advanced, her-2 positive
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.
Interventions
DRUGvinorelbine
25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients
DRUGcarboplatin
AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients
DRUGtrastuzumab
8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression
Sponsors
National Cancer Institute, Naples
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate | after 3 and 6 cycles of therapy |
| side effects | after every cycle of therapy |
Secondary
| Measure | Time frame |
|---|---|
| time to progression | at 12 months, end of study |
| overall survival | at 12 months, end of study |
Countries
Italy
Outcome results
None listed