Breast Cancer
Conditions
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.
Interventions
OTHERNo Intervention
No intervention administered in this study.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Having been randomized in the IMELDA MO22223 P-trial
Exclusion criteria
Not having been randomized in the IMELDA MO22223 P-trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy | Up to 78 months | Participants who had prematurely withdrawn from maintenance study treatment were reported.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. |
Countries
Brazil, France, India, Italy, Spain, Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed. | 0 |
| Bevacizumab and Capecitabine Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative/Other | 2 | 4 |
| Overall Study | Death | 53 | 33 |
| Overall Study | Investigator's Decision | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 1 |
| Overall Study | Withdrew Consent | 1 | 6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Up to 78 months
Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Overall Survival | 22.3 months |
| Bevacizumab and Capecitabine | Overall Survival | 36.5 months |
Primary
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.
Time frame: Up to 78 months
Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy | 93.2 percentage of participants |
| Bevacizumab and Capecitabine | Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy | 84.7 percentage of participants |
Primary
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.
Time frame: Up to 78 months
Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment | 94.9 percentage of participants |
| Bevacizumab and Capecitabine | Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment | 91.5 percentage of participants |
Primary
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.
Time frame: Up to 78 months
Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Progression Free Survival (PFS) | 4.3 months |
| Bevacizumab and Capecitabine | Progression Free Survival (PFS) | 12.2 months |
Primary
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.
Time frame: Up to 78 months
Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy | 22.5 days |
| Bevacizumab and Capecitabine | Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy | 23.5 days |