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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383576
• Other study ID #: MO29587
• Status: Completed
• First received: March 4, 2015
• Last updated: September 6, 2017
• Start date: April 30, 2015
• Est. completion date: January 22, 2016

Study information

• Verified date: September 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: January 22, 2016
• Est. primary completion date: January 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Having been randomized in the IMELDA MO22223 P-trial

Exclusion Criteria:

Not having been randomized in the IMELDA MO22223 P-trial

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• No Intervention
No intervention administered in this study.

Locations

Country	Name	City	State
Brazil	Crio - Centro Regional Integrado de Oncologia	Fortaleza	CE
Brazil	Hospital de Caridade de Ijui; Oncologia	Ijui	RS
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Instituto Nacional de Cancer - INCa; Oncologia	Rio de Janeiro	RJ
Brazil	Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia	Santo Andre	SP
Brazil	Hospital Santa Marcelina;Oncologia	Sao Paulo	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
France	HOPITAL JEAN MINJOZ; Oncologie	Besancon
France	Chg de Chartres Hopital Louis Pasteur; Pneumologie	Chartres
France	Clinique Sainte Marguerite; Oncologie Medicale	Hyeres
France	Centre Bourgogne, Service de Radiotherapie	Lille
France	HOPITAL TENON; Cancerologie Medicale	Paris
France	Institut Curie; Oncologie Medicale	Paris
France	Clinique Francheville; Radiotherapie	Perigueux
France	Institut D Oncologie Medical	Strasbourg
India	Tata Memorial Hospital; Dept of Medical Oncology	Mumbai	Maharashtra
India	Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology	New Delhi	Delhi
Italy	Ospedale Antonio Perrino; Oncologia Medica	Brindisi	Puglia
Italy	Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico	Genova	Liguria
Italy	Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica	Napoli	Campania
Spain	Complejo Hospitalario la Mancha Centro;Servicio Oncologia	Alcazar de S. Juan	Ciudad Real
Spain	Hospital Virgen de los Lirios; Servicio de Oncologia	Alcoy	Alicante
Spain	Hospital de Cruces; Servicio de Oncologia	Barakaldo	Vizcaya
Spain	Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia	Jaen
Spain	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Malaga
Spain	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona
Spain	Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia	Toledo
Spain	Hospital Universitario la Fe; Servicio de Oncologia	Valencia
Turkey	Gazi Uni Medical Faculty Hospital; Oncology Dept	Ankara
Turkey	Akdeniz University Medical Faculty; Medical Oncology Department	Antalya
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye, ANKARA

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Brazil,  France,  India,  Italy,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 78 months
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.	Up to 78 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.	Up to 78 months
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.	Up to 78 months
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.	Up to 78 months