Abstract 1113
Background
Ribociclib in combination with endocrine therapy (ET) is the current standard of care in first-line for HR+/HER2- aBC. An increasing proportion of patients who are candidates for ribociclib are older (≥70 years of age). The number of older patients who have participated thus far in ribocicib trials is, however, small, and little data is available on the tolerability of ribociclib in this population, particularly among frail older patients. Previous trials, moreover, do not usually include older patient-specific methods of evaluation (comprehensive geriatric assessment). RIBOB addresses the issue of efficacy and tolerability of ribociclib in older patients, including frail patients and patients with multiple comorbidities as is frequent in clinical practice.
Trial design
Ribob is a prospective, open lable, single arm trial which will evaluate the clinical efficacy, overall safety and tolerability of ribociclib in combination with letrozole in older women (≥70 years) with HR+/HER2- aBC and no prior hormonal treatment for advanced disease (as per approved indication). Frail patients, patients with comorbidities and patients with altered laboratory tests for whom treatment is deemed adequate and safe by the local investigator are eligible. Exclusion criteria include patients with uncontrolled brain lesions and QTc interval prolongation. A total of 150 patients will be enrolled for treatment with Letrozole (2.5 mg once daily) + ribociclib 600 mg (day 1 to 21 in a 28 day cycle) until progression, intolerable toxicity or patient/physician decision to withdraw. Study end-points include PFS, OS, safety and functionality, which will be evaluated through EORTC QLQ-C30 (modified) and EORTC IL15 questionnaires as well comprehensive geriatric assessment at baseline, 3 months and 1 year. Translational research will include the collection of plasma samples which will be obtained to evaluate aging biomarkers and thymidine kinase and their impact on efficacy and toxicity. Recruitment is open since January/2019.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
UZ Leuven.
Funding
Novartis.
Disclosure
N.F. Ponde: Research grant / Funding (self), Travel Grant: Novartis. L. Decoster: Research grant / Funding (self): Boehringer-Ingelheim; Research grant / Funding (self): Roche; Research grant / Funding (self): BMS. E. de Azambuja: Speaker Bureau / Expert testimony, Research grant / Funding (self): Roche; Research grant / Funding (self): GSK. G. Jerusalem: Honoraria (self), Research grant / Funding (self): Novartis; Honoraria (self), Research grant / Funding (self): Roche; Honoraria (self), Research grant / Funding (self): Amgen; Honoraria (self), Research grant / Funding (self): BMS; Honoraria (self): Pfizer; Honoraria (self): Puma; Honoraria (self): Daiichi-Sankyo; Honoraria (self): AZ; Honoraria (self): Lilly; Honoraria (self): Celgene; Research grant / Funding (self): MSD. P. Vuylsteke: Research grant / Funding (self): Roche. H. Wildiers: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Novartis; Advisory / Consultancy, Research grant / Funding (self): Roche; Advisory / Consultancy: Celldex; Advisory / Consultancy, Research grant / Funding (self): Pfizer; Advisory / Consultancy, Research grant / Funding (self): PUMA. All other authors have declared no conflicts of interest.
Resources from the same session
5747 - The routine use of sentinel lymph node biopsy in high risk DCIS lesions is not justified
Presenter: Fanny Preat
Session: Poster Display session 2
Resources:
Abstract
1837 - Oncological impact of re-excision for positive margin status after breast conserving surgery in invasive breast cancer
Presenter: Kenjiro Jimbo
Session: Poster Display session 2
Resources:
Abstract
4347 - Pneumonitis and fibrosis after breast cancer radiation.
Presenter: Jarle Karlsen
Session: Poster Display session 2
Resources:
Abstract
2280 - Prognosis of mastectomy with reconstruction after neoadjuvant chemotherapy: a nationwide study in Korean Breast Cancer Society
Presenter: Sungmin Park
Session: Poster Display session 2
Resources:
Abstract
804 - A negative prognosis of radiotherapy-induced lower lymphocyte to monocyte ratio in patients with breast cancer
Presenter: Chang-ik Yoon
Session: Poster Display session 2
Resources:
Abstract
2701 - Patient data to monitor clinical patterns in early and advanced breast cancer in Europe
Presenter: Francesco Giusti
Session: Poster Display session 2
Resources:
Abstract
1437 - A critical appraisal of quality indicators of breast cancer treatment in Belgium
Presenter: Didier Verhoeven
Session: Poster Display session 2
Resources:
Abstract
1534 - Predictors of adherence among post-menopausal women receiving adjuvant endocrine therapy for breast cancer in Ontario, Canada
Presenter: Phillip Blanchette
Session: Poster Display session 2
Resources:
Abstract
4363 - Evaluation of endocrine therapy and patients preferences in early breast cancer: results of Elena study
Presenter: Emilia Montagna
Session: Poster Display session 2
Resources:
Abstract
2679 - Baseline Quality of life (QoL) and chemotherapy related toxicities (CRT) in localized breast cancer (BC) patients (pts): the French multicentric prospective CANTO cohort study
Presenter: Idlir Licaj
Session: Poster Display session 2
Resources:
Abstract