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
714 - The feasibility and efficacy of gonadotropin-releasing hormone agonists for prevention of chemotherapy-induced ovarian insufficiency in patient with malignant ovarian germ cell tumors
Presenter: Min Kyu Kim
Session: Poster Display session 2
Resources:
Abstract
1753 - Ex vivo cytotoxicity and in vivo antitumor activity of a novel highly selective STAT3 inhibitor YHO-1701 for ovarian and endometrial cancer
Presenter: Kosei Hasegawa
Session: Poster Display session 2
Resources:
Abstract
3739 - Mutational landscapes and tumor mutational burden expression in endometrial cancer
Presenter: Yingli Zhang
Session: Poster Display session 2
Resources:
Abstract
2109 - Clinical features and frequency of mismatch repair protein deficiency in ovarian clear cell and endometrioid carcinoma patients.
Presenter: Kazuhiro Takehara
Session: Poster Display session 2
Resources:
Abstract
4554 - Prospective study evaluating white adipose tissue inflammation and clinicopathologic features in endometrial cancer
Presenter: Lea Moukarzel
Session: Poster Display session 2
Resources:
Abstract
3645 - Cancer-specific survival with or without adjuvant chemotherapy in high-risk stage I endometrial cancer
Presenter: Jenny Ko
Session: Poster Display session 2
Resources:
Abstract
3394 - Pembrolizumab in Patients with MSI-H Advanced Endometrial Cancer from the KEYNOTE-158 Study
Presenter: David Omalley
Session: Poster Display session 2
Resources:
Abstract
3388 - Who drops out of cervical cancer screening? Results from the EDIFICE 6 survey
Presenter: Thibault de La Motte Rouge
Session: Poster Display session 2
Resources:
Abstract
2485 - Identification of a RNA-Seq Based Signature to Improve Prognostic for Uterine Sarcoma
Presenter: Jian-Guo Zhou
Session: Poster Display session 2
Resources:
Abstract
1049 - The Effect Of Multiple Interventions For Women At Risk For Cervical Cancer On Their Health Responsibility, Beliefs Regarding Cervical Cancer, And Having Screening: A Randomized Controlled Experiment
Presenter: Busra Altinel
Session: Poster Display session 2
Resources:
Abstract