NCT00431704

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
16.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

16.2 years

First QC Date

February 5, 2007

Last Update Submit

March 23, 2023

Conditions

Metastatic Breast Cancer

Keywords

advancedher-2 positive

Outcome Measures

Primary Outcomes (2)

  • objective response rate

    after 3 and 6 cycles of therapy

  • side effects

    after every cycle of therapy

Secondary Outcomes (2)

  • time to progression

    at 12 months, end of study

  • overall survival

    at 12 months, end of study

Study Arms (1)

vinorelbine, carboplatin, trastuzumab

EXPERIMENTAL
Drug: vinorelbineDrug: carboplatinDrug: trastuzumab

Interventions

vinorelbineDRUG

25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients

vinorelbine, carboplatin, trastuzumab
carboplatinDRUG

AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients

vinorelbine, carboplatin, trastuzumab
trastuzumabDRUG

8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression

vinorelbine, carboplatin, trastuzumab

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

VinorelbineCarboplatinTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCoordination ComplexesOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Andrea De Matteis, M.D.

    NCI Naples, Division of Medical Oncology C

    PRINCIPAL INVESTIGATOR

  • Francesco Perrone, M.D., Ph.D.

    NCI Naples, Clinical Trials Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 6, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

IT(1)