NCT03979911

Brief Summary

This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.

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
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 22, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

June 7, 2019

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

April 17, 2019

Last Update Submit

June 6, 2019

Conditions

Breast NeoplasmsHER-2 Gene Amplification

Keywords

PertuzumabBreast Neoplasms/pathologyReal lifeTrastuzumabReceptor, ErbB-2/antagonists & inhibitors*Breast Neoplasms/drug therapy*Multicenter StudyTaxoidsAntibodies, Monoclonal, Humanized

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival

    time between inclusion and progression of the disease

    through study completion, an average of 1 year

  • overall survival

    time between inclusion and death

    through study completion, an average of 1 year

Secondary Outcomes (8)

  • comparison of the age of our population to those of the CLEOPATRA cohort

    at the inclusion

  • comparison of the % of patients who had a previous chemotherapy in our population to those of the CLEOPATRA cohort

    at the inclusion

  • comparison of the % of patients who had visceral metastasis in our population to those of the CLEOPATRA cohort

    at the inclusion

  • comparison of the % of patients who had brain metastasis in our population to those of the CLEOPATRA cohort

    at the inclusion

  • comparison of the % of patients who had positive hormonal receptors in our population to those of the CLEOPATRA cohort

    at the inclusion

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic breast cancer HER2 positive who received pertuzumab in combination with trastuzumab and taxane chemotherapy

You may qualify if:

  • metastatic breast cancer
  • HER2 positive
  • Received pertuzumab in combination with trastuzumab and taxane chemotherapy

You may not qualify if:

  • no HER2-positive breast cancer
  • no association with taxane chemotherapy
  • no metastatic breast cancer
  • refusal to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Helene SIMON

CONTACT

02-98-22-34-51helene.simon@chu-brest.fr

Paul Bore

CONTACT

paul.bore@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2019

First Posted

June 7, 2019

Study Start

January 22, 2019

Primary Completion

July 22, 2019

Study Completion

July 22, 2019

Last Updated

June 7, 2019

Record last verified: 2018-11

Locations

FR(1)