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

NCT02383576 | Completed Results

• 1 other identifier: MO29587
• Study Type: observational
• Target: 185
• Locations: 6 countries
• Sites: 32

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy

  Participants who had prematurely withdrawn from maintenance study treatment were reported.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.

  Up to 78 months

• Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment

  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.

  Up to 78 months

• Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy

  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.

  Up to 78 months

• Progression Free Survival (PFS)

  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.

  Up to 78 months

• Overall Survival

  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.

  Up to 78 months

Study Arms (2)

Bevacizumab

Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.

Other: No Intervention

Bevacizumab and Capecitabine

Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.

Other: No Intervention

Interventions

No Intervention OTHER

No intervention administered in this study.

Bevacizumab; Bevacizumab and Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All participants randomized in IMELDA (MO22223)

You may qualify if:

• Having been randomized in the IMELDA MO22223 P-trial

You may not qualify if:

• Not having been randomized in the IMELDA MO22223 P-trial

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (32)

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60336-550, Brazil

Location

Instituto Nacional de Cancer - INCa; Oncologia

Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

Location

Hospital de Caridade de Ijui; Oncologia

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-080, Brazil

Location

Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

Santo André, São Paulo, 09060-650, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Hospital Santa Marcelina;Oncologia

São Paulo, São Paulo, 08270-070, Brazil

Location

HOPITAL JEAN MINJOZ; Oncologie

Besançon, 25030, France

Location

Chg de Chartres Hopital Louis Pasteur; Pneumologie

Chartres, 28018, France

Location

Clinique Sainte Marguerite; Oncologie Medicale

Hyères, 83400, France

Location

Centre Bourgogne, Service de Radiotherapie

Lille, 59000, France

Location

Institut Curie; Oncologie Medicale

Paris, 75231, France

Location

HOPITAL TENON; Cancerologie Medicale

Paris, 75970, France

Location

Clinique Francheville; Radiotherapie

Périgueux, 24000, France

Location

Institut D Oncologie Medical

Strasbourg, 67000, France

Location

Tata Memorial Hospital; Dept of Medical Oncology

Mumbai, Maharashtra, 400012, India

Location

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Ospedale Antonio Perrino; Oncologia Medica

Brindisi, Apulia, 72100, Italy

Location

Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica

Napoli, Campania, 80131, Italy

Location

Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico

Genoa, Liguria, 16132, Italy

Location

Hospital Virgen de los Lirios; Servicio de Oncologia

Alcoy, Alicante, 03804, Spain

Location

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, 08208, Spain

Location

Complejo Hospitalario la Mancha Centro;Servicio Oncologia

Alcazar de S. Juan, Ciudad Real, 13600, Spain

Location

Hospital de Cruces; Servicio de Oncologia

Barakaldo, Vizcaya, 48903, Spain

Location

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

Jaén, 23007, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Málaga, 29010, Spain

Location

Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

Toledo, 45004, Spain

Location

Hospital Universitario la Fe; Servicio de Oncologia

Valencia, 46026, Spain

Location

Gazi Uni Medical Faculty Hospital; Oncology Dept

Ankara, 06500, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty; Medical Oncology Department

Antalya, 07070, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sıhhiye, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Reference Study ID Number: MO29587 www.roche.com/about_rouche/roche_worldwide.htm

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 9, 2015
• Study Start: April 30, 2015
• Primary Completion: January 22, 2016
• Study Completion: January 22, 2016
• Last Updated: April 13, 2018
• Results First Posted: April 13, 2018

Record last verified: 2017-09

Locations

ES (8); FR (8); IN (2); BR (8); IT (3); TU (3)