Clinical trial NCT02383576: Retrospective Data Collection: Post Study Treatment Anticancer Therapy From IMELDA MO22223
Official title: Retrospective Data Collection: Post Study Treatment Anticancer Therapy From All Randomized Patients Involved in IMELDA MO22223
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-03-09
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants randomized in IMELDA (MO22223)

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.


Eligibility criteria: Inclusion Criteria:

Having been randomized in the IMELDA MO22223 P-trial

Exclusion Criteria:

Not having been randomized in the IMELDA MO22223 P-trial

Primary outcomes:
measure: Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy
timeFrame: Up to 78 months
measure: Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment
timeFrame: Up to 78 months
measure: Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy
timeFrame: Up to 78 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 78 months
measure: Overall Survival
timeFrame: Up to 78 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Crio - Centro Regional Integrado de Oncologia
state: CE
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa; Oncologia
state: RJ
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui; Oncologia
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: SP
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Santa Marcelina;Oncologia
state: SP
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Chartres
country: France
facility: Chg de Chartres Hopital Louis Pasteur; Pneumologie
city: Hyeres
country: France
facility: Clinique Sainte Marguerite; Oncologie Medicale
city: Lille
country: France
facility: Centre Bourgogne, Service de Radiotherapie
city: Paris
country: France
facility: Institut Curie; Oncologie Medicale
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Perigueux
country: France
facility: Clinique Francheville; Radiotherapie
city: Strasbourg
country: France
facility: Institut D Oncologie Medical
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
state: Delhi
city: Mumbai
country: India
facility: Tata Memorial Hospital; Dept of Medical Oncology
state: Maharashtra
city: Napoli
country: Italy
facility: Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica
state: Campania
city: Genova
country: Italy
facility: Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico
state: Liguria
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino; Oncologia Medica
state: Puglia
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios; Servicio de Oncologia
state: Alicante
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Alcazar de S. Juan
country: Spain
facility: Complejo Hospitalario la Mancha Centro;Servicio Oncologia
state: Ciudad Real
city: Barakaldo
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Oncologia
city: Ankara
country: Turkey
facility: Gazi Uni Medical Faculty Hospital; Oncology Dept
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty; Medical Oncology Department
city: Sıhhiye, ANKARA
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Study officials:
affiliation: Hoffmann-La Roche
name: Reference Study ID Number: MO29587 www.roche.com/about_rouche/roche_worldwide.htm
role: STUDY_DIRECTOR
References: