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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed. |
| |
| Bevacizumab and Capecitabine | Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No intervention administered in this study. |
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| 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| Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy | Participants who had prematurely withdrawn from maintenance study treatment were reported.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. |
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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
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All participants randomized in IMELDA (MO22223)
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| Name | Affiliation | Role |
|---|---|---|
| Reference Study ID Number: MO29587 www.roche.com/about_rouche/roche_worldwide.htm | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crio - Centro Regional Integrado de Oncologia | Fortaleza | Ceará | 60336-550 | Brazil | ||
| Instituto Nacional de Cancer - INCa; Oncologia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed. |
| FG001 | Bevacizumab and Capecitabine | Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Up to 78 months |
| Rio de Janeiro |
| Rio de Janeiro |
| 20560-120 |
| Brazil |
| Hospital de Caridade de Ijui; Oncologia | Ijuà | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210-080 | Brazil |
| Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia | Santo André | São Paulo | 09060-650 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Hospital Santa Marcelina;Oncologia | São Paulo | São Paulo | 08270-070 | Brazil |
| HOPITAL JEAN MINJOZ; Oncologie | Besançon | 25030 | France |
| Chg de Chartres Hopital Louis Pasteur; Pneumologie | Chartres | 28018 | France |
| Clinique Sainte Marguerite; Oncologie Medicale | Hyères | 83400 | France |
| Centre Bourgogne, Service de Radiotherapie | Lille | 59000 | France |
| Institut Curie; Oncologie Medicale | Paris | 75231 | France |
| HOPITAL TENON; Cancerologie Medicale | Paris | 75970 | France |
| Clinique Francheville; Radiotherapie | Périgueux | 24000 | France |
| Institut D Oncologie Medical | Strasbourg | 67000 | France |
| Tata Memorial Hospital; Dept of Medical Oncology | Mumbai | Maharashtra | 400012 | India |
| Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology | New Delhi | National Capital Territory of Delhi | 110085 | India |
| Ospedale Antonio Perrino; Oncologia Medica | Brindisi | Apulia | 72100 | Italy |
| Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica | Naples | Campania | 80131 | Italy |
| Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico | Genoa | Liguria | 16132 | Italy |
| Hospital Virgen de los Lirios; Servicio de Oncologia | Alcoy | Alicante | 03804 | Spain |
| Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | 08208 | Spain |
| Complejo Hospitalario la Mancha Centro;Servicio Oncologia | Alcazar de S. Juan | Ciudad Real | 13600 | Spain |
| Hospital de Cruces; Servicio de Oncologia | Barakaldo | Vizcaya | 48903 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaén | 23007 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Málaga | 29010 | Spain |
| Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia | Toledo | 45004 | Spain |
| Hospital Universitario la Fe; Servicio de Oncologia | Valencia | 46026 | Spain |
| Gazi Uni Medical Faculty Hospital; Oncology Dept | Ankara | 06500 | Turkey (Türkiye) |
| Akdeniz University Medical Faculty; Medical Oncology Department | Antalya | 07070 | Turkey (Türkiye) |
| Hacettepe Uni Medical Faculty Hospital; Oncology Dept | Sıhhiye, Ankara | 06100 | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
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It is a retrospective collection of additional anti-cancer medications that participants might have taken after a progression free survival (PFS) event in the main Imelda study. Demographic data was not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed. |
| BG001 | Bevacizumab and Capecitabine | Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | years | ||||||||||||||||||||
| Sex: Female, Male |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of participants | Up to 78 months |
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| 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. | 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. | Posted | Number | percentage of participants | Up to 78 months |
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| 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. | 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. | Posted | Median | Full Range | days | Up to 78 months |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | months | Up to 78 months |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | months | Up to 78 months |
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This study only collected retrospective data on anti-cancer therapies taken by patients after the end of the IMELDA (MO22223) P-trial and no adverse event data was collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab | Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed. | 0 | 0 | 0 | 0 | ||
| EG001 | Bevacizumab and Capecitabine | Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed. | 0 | 0 | 0 | 0 |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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