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Completed

NCT Number: NCT02383576

Retrospective Data Collection: Post Study Treatment Anticancer Therapy From 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Crio - Centro Regional Integrado de Oncologia, Fortaleza, Ceará, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Having been randomized in the IMELDA MO22223 P-trial

Exclusion criteria

Not having been randomized in the IMELDA MO22223 P-trial

Treatment and study plan

No intervention

Other

No intervention administered in this study.

Primary outcomes

  1. Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy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    Participants who had prematurely withdrawn from maintenance study treatment were reported.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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2015
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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