FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer (FACILE)
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|ClinicalTrials.gov Identifier: NCT03944434|
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : March 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Ribociclib Drug: Aromatase Inhibitors, non steroideal Drug: LHRH agonist||Phase 2|
Elderly patients are generally more susceptible to the side effects of active treatments. Patients entered in clinical trials, especially the elderly, are not completely representative of the "real" population because of selection process. The lack of data collected from a real population turns the indication of treatment a challenging task and expose older patients to a risk of under treatment (fear of excessive toxicity because of the lack of data).
With the aim of covering this gap, we are planning to run a phase II trial evaluating the feasibility of delivering the combination of ribociclib plus NSAI as first-line treatment specifically in a population of breast cancer patients aged ≥70 years.
• The treatment feasibility will be evaluated as the proportion of patients not having experienced disease progression (PD), still on treatment with ribociclib plus NSAI 6 months after the first drug administration
- Treatment adherence
- Safety and tolerability
- Patient reported outcomes (PROs)
- Overall response rate (ORR)
- Progression free survival (PFS)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||194 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Multicenter, Single Arm Trial to Assess the Feasibility of First Line Ribociclib in Combination With a Non Steroidal Aromatase Inhibitor in Elderly Patients With Hormone Receptor Positive/HER2 Negative Advanced Breast Cancer|
|Actual Study Start Date :||December 27, 2018|
|Estimated Primary Completion Date :||June 27, 2022|
|Estimated Study Completion Date :||November 27, 2025|
Experimental: single arm
patients will receive anastrozole tablets (1 mg once daily) or letrozole tablets (2.5 mg once daily) + ribociclib tablets (600 mg day 1 to 21 in a 28 day cycle). Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, physician's decision, patient's refusal/consent withdrawal, or lost to follow-up.
A LHRH agonist (triptorelin 3,75 mg or leuprolide 3,75 mg or goserelin 3,6 mg, as injectable intramuscular (i.m.) or subcutaneous (s.c.) implant every 28 days) will be used in men.
ribociclib 600 mg/day orally
Other Name: Kisqali
Drug: Aromatase Inhibitors, non steroideal
letrozole 2.5 mg/day orally or anastrozole 1 mg/day orally
Drug: LHRH agonist
Triptorelin 3,75 mg or Leuprolide 3,75 mg or goserelin 3,6 mg, as injectable.
- Treatment feasibility [ Time Frame: 6 months ]The treatment feasibility will be evaluated as the proportion of patients not having experienced disease progression (PD), still on treatment with ribociclib plus NSAI 6 months after the first drug administration
- Patient Diary [ Time Frame: 36 months ]Diary to self-report data regarding taking medication and to evaluate treatment adherence
- Incidence of Treatment-Emergent adverse events and serious adverse events (Safety and tolerability) [ Time Frame: 36 months ]Adverse events (AE), AE of special interest and serious adverse events (SAE). CTCAE V. 5.0 will be adopted.
- Patient reported outcomes (PROs) [ Time Frame: 36 months ]PROs using Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire, score: 0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much;
- Overall response rate (ORR) [ Time Frame: 36 months ]ORR as defined by RECIST 1.1 for patients with measurable disease
- Progression free survival (PFS) [ Time Frame: 36 months ]PFS as defined by RECIST 1.1 based on investigator' assessment
- Number of comorbities (impact on study inclusion) [ Time Frame: 30 months ]Number of comorbidities and relative grading will be collected using Cumulative Illness Rating Scale- Geriatric (CIRS-G) (for patients not included into the study due to comorbities).SCORE: 0- No problem , 1- Current mild problem or past significant problem, 2- Moderate disability or morbidity/requires first line therapy, 3- Severe/ constant significant disability/ uncontrollable chronic problems, 4- Extremely severe/ immediate treatment required/ end organ failure/ severe impairment in function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944434
|Contact: Donata Cavaciocchi, MSfirstname.lastname@example.org|
|Contact: Emanuela Risi, MDemail@example.com|
|Principal Investigator:||Laura Biganzoli, MD||Hospital of Prato|