Retrospective Data Collection: Post Study Treatment Anticancer Therapy From IMELDA MO22223

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02383576
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study aims to understand better the effective results from the IMELDA MO22223 P-trial (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after study treatments were terminated possibly had an effect on efficacy results.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-09
• Study Start: 2015-04-30
• Primary Completion: 2016-01-22
• Study Completion: 2016-01-22
• Results First Submitted: 2017-04-19
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-06
• Last Update Submitted: 2017-09-06
• Results First Posted: 2018-04-13
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

Having been randomized in the IMELDA MO22223 P-trial

Exclusion Criteria

Not having been randomized in the IMELDA MO22223 P-trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy	Up to 78 months	Participants who had prematurely withdrawn from maintenance study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment	Up to 78 months	Participants who received further anti-cancer therapies after discontinuation of study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy	Up to 78 months	Time from last maintenance study medication to the start of any further anti-cancer therapy was reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Progression Free Survival (PFS)	Up to 78 months	PFS was defined as the time from start of the study to the first documented occurrence of disease progression. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Overall Survival	Up to 78 months	Overall survival was defined as the interval between start of the study and the date of death from any cause. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.

Trial Locations

Locations (32)

Crio - Centro Regional Integrado de Oncologia; 🇧🇷 Fortaleza, CE, Brazil

Instituto Nacional de Cancer - INCa; Oncologia; 🇧🇷 Rio de Janeiro, RJ, Brazil

Hospital de Caridade de Ijui; Oncologia; 🇧🇷 Ijui, RS, Brazil

Hospital das Clinicas - UFRGS; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Amaral Carvalho; 🇧🇷 Jau, SP, Brazil

Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia; 🇧🇷 Santo Andre, SP, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP; 🇧🇷 Sao Paulo, SP, Brazil

Hospital Santa Marcelina;Oncologia; 🇧🇷 Sao Paulo, SP, Brazil

HOPITAL JEAN MINJOZ; Oncologie; 🇫🇷 Besancon, France

Chg de Chartres Hopital Louis Pasteur; Pneumologie; 🇫🇷 Chartres, France

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