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 FACILE: FeAsibility of first-line riboCIclib in oLdEr patients with advanced breast cancer - FACILE

FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI - ONLUS0 sites194 target enrollmentJanuary 20, 2021

ConditionsHR+, HER2 negative advanced breast cancer MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKisqali

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HR+, HER2 negative advanced breast cancer
Sponsor: FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI - ONLUS
Enrollment: 194
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 20, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI - ONLUS

Eligibility Criteria

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 laboratory.
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

•Patients eligible for this study must not meet any of the following criteria:
•1\.Patient has received prior treatment with chemotherapy or hormonal therapy (except for neoadjuvant/ adjuvant chemotherapy), or any CDK4/6 inhibitor.
•\-Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease\-free interval must be greater than 12 months from the completion of treatment until study entry.
•\-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.