Vern-sur-seiche, France
Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients
Phase
3Span
558 weeksSponsor
UNICANCERSarcelles
Recruiting
Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy
The purpose of the CARLHA-2 study is to determine if the combination of apalutamide with 6 months of LHRH agonists and radiotherapy results in an improvement of progression-free survival (PFS) in comparison to the combination of 6 months of LHRH agonists with radiotherapy in high-risk postprostatectomy biochemically relapsed prostate cancer patients. Radical prostatectomy must have been done at least 6 months before inclusion and is not part of this study. Patients after radical prostatectomy and biochemical relapse will be randomized in a 1:1 ratio to receive either 6 months of LHRH agonists + SRT or 6 months of LHRH agonists + SRT + 6 months of apalutamide. The stratification variables include Gleason score, prostate-specific antigen (PSA), negative resection margins, extension to seminal vesicle(s), and PSA doubling time.
Phase
3Span
729 weeksSponsor
UNICANCERSarcelles
Recruiting
DESTINY Breast Respond HER2-low Europe
This non-interventional study will investigate the effectiveness withT-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No drug product will be administered as part of this study. Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.
Phase
N/ASpan
254 weeksSponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanySarcelles
Recruiting
Sarcelles
Recruiting
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
Included patients will be followed until the end of study, death or lost to follow-up even if ribociclib and ET are discontinued. The end of the study is defined as 3 years after the first visit of the last patient included (Last Patient First Visit [LPFV]). The total duration of the study will be 4 years and half (18 months of inclusion + 3 years of follow-up). Thus, a patient included at the beginning of the inclusion period will be followed for 4 years and half and a patient included at the end of the inclusion period will be followed for at least 3 years.
Phase
N/ASpan
290 weeksSponsor
Novartis PharmaceuticalsSarcelles
Recruiting