NCT02860585

Brief Summary

The objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 27, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

September 26, 2017

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

August 4, 2016

Last Update Submit

September 25, 2017

Conditions

Breast Neoplasms

Keywords

Metastatic breast cancerhigh-dose chemotherapyautologous haematopoietic progenitor cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Overall Survival according to Immunohistochemical subtypes .

    8 years

Secondary Outcomes (1)

  • Progression free Survival according to Immunohistochemical subtypes .

    8 years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female patients treated for Metastatic breast Cancer with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation at the Institut Paoli-Calmettesbetween 2003 and 2012

You may qualify if:

  • Age\>18 years
  • Metastatic breast Cancer
  • Treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation between 2003 and 2012

You may not qualify if:

  • Lack of follow-up data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Christian Chabannon, MD,PhD

    Institut Paoli-Calmettes

    STUDY DIRECTOR

  • Anthony Gonçalves, MD,PhD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Study Start

September 27, 2013

Primary Completion

February 29, 2016

Study Completion

February 29, 2016

Last Updated

September 26, 2017

Record last verified: 2016-08

Locations

FR(1)