Condition or disease | Intervention/treatment | Phase |
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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.
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:
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 194 participants |
Allocation: | N/A |
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 27, 2018 |
Estimated Primary Completion Date : | June 27, 2022 |
Estimated Study Completion Date : | November 27, 2025 |
Arm | Intervention/treatment |
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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
Other Name: Kisqali
Drug: Aromatase Inhibitors, non steroideal letrozole 2.5 mg/day orally or anastrozole 1 mg/day orally
Other Names:
Drug: LHRH agonist Triptorelin 3,75 mg or Leuprolide 3,75 mg or goserelin 3,6 mg, as injectable.
Other Names:
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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has adequate bone marrow and organ function as defined by all of the following laboratory values (as assessed by local laboratory):
Patient must have a 12-lead ECG values with all of the following parameters at screening:
Exclusion Criteria:
NOTE:
Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.
2. Patient has a known hypersensitivity to any of the excipients of ribociclib or NSAI 3. Patient in concurrently using other anti-cancer therapy. 4. Patient who has not had resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
5. Patient who has received extended-field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to start of treatment, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). Patient from whom ≥ 25% of the bone marrow has been previously irradiated are also excluded 6. Patient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
7. Patient with central nervous system (CNS) metastases unless they meet all of the following criteria:
Clinically stable CNS lesions at the time of study treatment initiation and not receiving steroids and/or enzyme-inducing anti-epileptic medications for the management of brain metastases for at least 2 weeks.
8. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
9. Patient has a known history of HIV infection (testing not mandatory). 10. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgement, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.) 11. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
i. Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia ii. Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (within 5 half-lives or 7 days prior to starting study drug) iii. Inability to determine the QTcF interval on screening f. Systolic Blood Pressure (SBP) >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:
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:
Contact: Donata Cavaciocchi, MS | +390574802531 | donata.cavaciocchi@uslcentro.toscana.it | |
Contact: Emanuela Risi, MD | +390574802522 | emanuela.risi@uslcentro.toscana.it |
Italy | |
Hospital of Prato | Recruiting |
Prato, Please Select:, Italy, 59100 | |
Contact: Laura Biganzoli, MD +390574802531 laura.biganzoli@uslcentro.toscana.it | |
Contact: Emanuela Risi, MD PhD +390574802522 emanuela.risi@uslcentro.toscana.it |
Principal Investigator: | Laura Biganzoli, MD | Hospital of Prato |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 9, 2019 | ||||||||
First Posted Date ICMJE | May 9, 2019 | ||||||||
Last Update Posted Date | December 10, 2020 | ||||||||
Actual Study Start Date ICMJE | December 27, 2018 | ||||||||
Estimated Primary Completion Date | June 27, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer | ||||||||
Official Title ICMJE | 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 | ||||||||
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 | ||||||||
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:
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | Breast Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | 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. Interventions:
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
194 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | November 27, 2025 | ||||||||
Estimated Primary Completion Date | June 27, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
NOTE:
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Sex/Gender ICMJE |
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Ages ICMJE | 70 Years and older (Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Italy | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03944434 | ||||||||
Other Study ID Numbers ICMJE | FACILE | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Fondazione Sandro Pitigliani | ||||||||
Study Sponsor ICMJE | Fondazione Sandro Pitigliani | ||||||||
Collaborators ICMJE | Novartis | ||||||||
Investigators ICMJE |
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PRS Account | Fondazione Sandro Pitigliani | ||||||||
Verification Date | June 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |