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

September 6, 2017 updated by: Hoffmann-La Roche

Retrospective Data Collection: Post Study Treatment Anticancer Therapy From All Randomized Patients Involved in IMELDA MO22223

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • CE
      • Fortaleza, CE, Brazil, 60336-550
        • CRIO - Centro Regional Integrado de Oncologia
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20560-120
        • Instituto Nacional de Cancer - INCa; Oncologia
    • RS
      • Ijui, RS, Brazil, 98700-000
        • Hospital de Caridade de Ijui; Oncologia
      • Porto Alegre, RS, Brazil, 90035-003
        • Hospital das Clinicas - UFRGS
    • SP
      • Jau, SP, Brazil, 17210-080
        • Hospital Amaral Carvalho
      • Santo Andre, SP, Brazil, 09060-650
        • Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • Sao Paulo, SP, Brazil, 08270-070
        • Hospital Santa Marcelina;Oncologia
  • France
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Chartres, France, 28018
        • Chg de Chartres Hopital Louis Pasteur; Pneumologie
      • Hyeres, France, 83400
        • Clinique Sainte Marguerite; Oncologie Medicale
      • Lille, France, 59000
        • Centre Bourgogne, Service de Radiotherapie
      • Paris, France, 75231
        • Institut Curie; Oncologie Medicale
      • Paris, France, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Perigueux, France, 24000
        • Clinique Francheville; Radiotherapie
      • Strasbourg, France, 67000
        • Institut D Oncologie Medical
  • India
    • Delhi
      • New Delhi, Delhi, India, 110085
        • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Hospital; Dept of Medical Oncology
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico
    • Puglia
      • Brindisi, Puglia, Italy, 72100
        • Ospedale Antonio Perrino; Oncologia Medica
  • Spain
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
      • Malaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
      • Toledo, Spain, 45004
        • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
      • Valencia, Spain, 46026
        • Hospital Universitario la Fe; Servicio de Oncologia
    • Alicante
      • Alcoy, Alicante, Spain, 03804
        • Hospital Virgen de los Lirios; Servicio de Oncologia
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Ciudad Real
      • Alcazar de S. Juan, Ciudad Real, Spain, 13600
        • Complejo Hospitalario la Mancha Centro;Servicio Oncologia
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces; Servicio de Oncologia
  • Turkey
      • Ankara, Turkey, 06500
        • Gazi Uni Medical Faculty Hospital; Oncology Dept
      • Antalya, Turkey, 07070
        • Akdeniz University Medical Faculty; Medical Oncology Department
      • Sıhhiye, ANKARA, Turkey, 06100
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All participants randomized in IMELDA (MO22223)

Description

Inclusion Criteria:

Having been randomized in the IMELDA MO22223 P-trial

Exclusion Criteria:

Not having been randomized in the IMELDA MO22223 P-trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bevacizumab
Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Other: No Intervention
No intervention administered in this study.
Bevacizumab and Capecitabine
Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Other: No Intervention
No intervention administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy
Time Frame: 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.
Up to 78 months
Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment
Time Frame: 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.
Up to 78 months
Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy
Time Frame: 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.
Up to 78 months
Progression Free Survival (PFS)
Time Frame: 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.
Up to 78 months
Overall Survival
Time Frame: 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.
Up to 78 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Reference Study ID Number: MO29587 www.roche.com/about_rouche/roche_worldwide.htm, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2015

Primary Completion (Actual)

January 22, 2016

Study Completion (Actual)

January 22, 2016

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 13, 2018

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • MO29587

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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