Evaluation of Survival in Patients With Metastatic Breast... | NCT02860585

Studies
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation

NCT02860585

Sponsor

Institut Paoli-Calmettes

Status

Completed

Last Update Posted

Sep 26, 2017Actual

Enrollment

235Actual

Phase

Not provided

Conditions

Breast Neoplasms

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 27, 2013Actual

Primary Completion Date

Feb 29, 2016Actual

Completion Date

Feb 29, 2016Actual

First Submitted Date

Aug 4, 2016

First Submission Date that Met QC Criteria

Aug 4, 2016

First Posted Date

Aug 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2017

Last Update Posted Date

Sep 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

235Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival according to Immunohistochemical subtypes .		8 years

Secondary Outcomes

Measure	Description	Time Frame
Progression free Survival according to Immunohistochemical subtypes .		8 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Lack of follow-up data

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Chabannon, MD,PhD	Institut Paoli-Calmettes	Study Director
Anthony Gonçalves, MD,PhD	Institut Paoli-Calmettes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Paoli-Calmettes		Marseille		13009	France

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided