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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer

Clinicaltrials.gov identifier NCT03944434

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted June 24, 2019

Study Description

Brief summary:

Phase II, multicenter, single arm trial to assess the feasibility of first line ribociclib in combination with a non steroidal aromatase inhibitor in women or men aged 70 years-old or older, with hormone receptor positive/HER2 negative advanced breast cancer

  • Condition or Disease:Breast Cancer
  • Intervention/Treatment: Drug: Aromatase Inhibitors, non steroideal
    Drug: LHRH agonist
    Drug: Ribociclib
  • Phase: Phase 2
Detailed Description

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. Primary endpoint: • 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 Secondary endpoints: - Treatment adherence - Safety and tolerability - Patient reported outcomes (PROs) - Overall response rate (ORR) - Progression free survival (PFS)

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 194 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • 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 2018
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: November 2025
Arms and interventions
Arm Intervention/treatment
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.
Drug: Ribociclib
ribociclib 600 mg/day orally

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.
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • Secondary Outcome Measures: 1. Patient Diary [ Time Frame: 36 months ]
    Diary to self-report data regarding taking medication and to evaluate treatment adherence
  • 2. 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.
  • 3. 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;
  • 4. Overall response rate (ORR) [ Time Frame: 36 months ]
    ORR as defined by RECIST 1.1 for patients with measurable disease
  • 5. Progression free survival (PFS) [ Time Frame: 36 months ]
    PFS as defined by RECIST 1.1 based on investigator' assessment
  • 6. 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
Eligibility Criteria
  • Ages Eligible for Study: 70 Years and older (Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients male or female, aged 70 years-old or older at the time of informed consent.

2. Patients with advanced (locoregionally recurrent or metastatic) breast cancer not
amenable to curative therapy.

3. Measurable or not measurable but evaluable disease according to RECIST criteria 1.1

4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen
receptor positive and/or progesterone receptor positive breast cancer by local

5. Patient has a HER2 negative breast cancer defined as a negative in situ hybridization
test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization
(FISH, CISH, or SISH) test is required by local laboratory testing.

6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

7. Patient has an estimated life expectancy of > 24 weeks.

8. Patient has adequate bone marrow and organ function as defined by all of the following
laboratory values (as assessed by local laboratory):

1. Absolute neutrophil count ≥1.5 x 109/L

2. Platelets ≥ 100 x 109/L

3. Hemoglobin ≥ 9.0 g/dL

4. Potassium, sodium, calcium corrected for serum albumin and magnesium within
normal limits or corrected to within normal limits with supplements before first
dose of the study medication

5. INR ≤ 1.5

6. Serum creatinine <1.5 mg/dl or creatinine clearance ≥50mL/min 7. Total bilirubin < ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN. 8. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be < 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN. 9. Patient must have a 12-lead ECG values with all of the following parameters at screening: 1. QTcF interval at screening 160 or <90 mmHg 12. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug: 1. Concomitant medications, herbal supplements, and/or fruits (e.g. grapefruit, pummeloes, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4/5, 2. Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. 13. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. NOTE: - The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)

Contacts and Locations

Contact: Donata Cavaciocchi, MS +390574802531 donata.cavaciocchi@uslcentro.toscana.it

Contact: Emanuela Risi, MD +390574802522 emanuela.risi@uslcentro.toscana.it


Italy, Please Select:
Hospital of Prato

Sponsors and Collaborators

Fondazione Sandro Pitigliani



Principal Investigator: Laura Biganzoli, MD Hospital of Prato

More Information