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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having been randomized in the IMELDA MO22223 P-trial Exclusion Criteria: Not having been randomized in the IMELDA MO22223 P-trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy | Participants who had prematurely withdrawn from maintenance study treatment were reported.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 |