Combined treatment (hormone and biological therapy) for patients with advanced breast cancer with hormone (HR) positive and HER2 negative receptors

Phase 1

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

• Registration Number: EUCTR2018-002514-12-IT
• Lead Sponsor: FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI - ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-20
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 194

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
F.1.3.1 Number of subjects for this age range 194

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.
NOTE:
-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To assess the feasibility of first-line treatment with ribociclib plus NSAI in a cohort of older patients with advanced breast cancer. ;Secondary Objective: •Treatment adherence <br>•Safety and tolerability <br>•Patient reported outcomes (PROs)<br>•Overall response rate (ORR)<br>•Progression free survival (PFS) <br>;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 6 months after the first drug administration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Treatment adherence ;Timepoint(s) of evaluation of this end point: 6 months after the first drug administration