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

Completed

• Conditions: Breast Cancer
• Interventions: Other: No Intervention

• 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

Arm && Interventions

Group	Intervention	Description
Bevacizumab	No Intervention	Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Bevacizumab and Capecitabine	No Intervention	Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.

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Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy	Up to 78 months	Participants who had prematurely withdrawn from maintenance study treatment were reported.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)

Hospital Virgen de los Lirios; Servicio de Oncologia; 🇪🇸 Alcoy, Alicante, Spain

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia; 🇪🇸 Sabadell, Barcelona, Spain

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

Hospital Amaral Carvalho; 🇧🇷 Jau, SP, Brazil

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

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

Clinique Sainte Marguerite; Oncologie Medicale; 🇫🇷 Hyeres, France

HOPITAL TENON; Cancerologie Medicale; 🇫🇷 Paris, France

Clinique Francheville; Radiotherapie; 🇫🇷 Perigueux, France

Tata Memorial Hospital; Dept of Medical Oncology; 🇮🇳 Mumbai, Maharashtra, India

Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico; 🇮🇹 Genova, Liguria, Italy

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology; 🇮🇳 New Delhi, Delhi, India

Ospedale Antonio Perrino; Oncologia Medica; 🇮🇹 Brindisi, Puglia, Italy

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

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

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

Hacettepe Uni Medical Faculty Hospital; Oncology Dept; 🇹🇷 Sıhhiye, ANKARA, Turkey

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

Complejo Hospitalario la Mancha Centro;Servicio Oncologia; 🇪🇸 Alcazar de S. Juan, Ciudad Real, Spain

Hospital de Cruces; Servicio de Oncologia; 🇪🇸 Barakaldo, Vizcaya, Spain

Hospital Universitario la Fe; Servicio de Oncologia; 🇪🇸 Valencia, Spain

HOPITAL JEAN MINJOZ; Oncologie; 🇫🇷 Besancon, France

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

Centre Bourgogne, Service de Radiotherapie; 🇫🇷 Lille, France

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia; 🇪🇸 Malaga, Spain

Gazi Uni Medical Faculty Hospital; Oncology Dept; 🇹🇷 Ankara, Turkey

Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia; 🇪🇸 Toledo, Spain

Institut Curie; Oncologie Medicale; 🇫🇷 Paris, France

Institut D Oncologie Medical; 🇫🇷 Strasbourg, France

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia; 🇪🇸 Jaen, Spain

Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica; 🇮🇹 Napoli, Campania, Italy

Akdeniz University Medical Faculty; Medical Oncology Department; 🇹🇷 Antalya, Turkey