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

Primary Purpose

Metastatic Breast Cancer

Status
Active
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
vinorelbine
carboplatin
trastuzumab
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring advanced, her-2 positive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vinorelbine, carboplatin, trastuzumab

Arm Description

Outcomes

Primary Outcome Measures

objective response rate
side effects

Secondary Outcome Measures

time to progression
overall survival

Full Information

First Posted
February 5, 2007
Last Updated
March 23, 2023
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00431704
Brief Title
VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
Acronym
VinCaT
Official Title
Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
advanced, her-2 positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vinorelbine, carboplatin, trastuzumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Intervention Description
25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Intervention Description
8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression
Primary Outcome Measure Information:
Title
objective response rate
Time Frame
after 3 and 6 cycles of therapy
Title
side effects
Time Frame
after every cycle of therapy
Secondary Outcome Measure Information:
Title
time to progression
Time Frame
at 12 months, end of study
Title
overall survival
Time Frame
at 12 months, end of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea De Matteis, M.D.
Organizational Affiliation
NCI Naples, Division of Medical Oncology C
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D.
Organizational Affiliation
NCI Naples, Clinical Trials Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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