Clinical trial NCT00431704: VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
Official title: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: advanced
her-2 positive
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2007-02-06
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: objective response rate
timeFrame: after 3 and 6 cycles of therapy
measure: side effects
timeFrame: after every cycle of therapy
Secondary outcomes:
measure: time to progression
timeFrame: at 12 months, end of study
measure: overall survival
timeFrame: at 12 months, end of study
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Study officials:
affiliation: NCI Naples, Division of Medical Oncology C
name: Andrea De Matteis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples, Clinical Trials Unit
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: