Study of the safety and efficacy of ribociclib 400mg in combination with endocrine therapy for the treatment of pre- and postmenopausal women with HR+, HER2- advanced breast cancer who received no previous therapy for advanced disease.

Phase 1

• Conditions: HR-positive, HER2-negative advanced breast cancer; MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; MedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: LLTClassification code 10073289Term: Premenopausal breast cancerSystem Organ Class: 100000004864

• Registration Number: EUCTR2018-004234-15-LT
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

-Patient has advanced (loco-regionally recurrent or metastatic) breast cancer not amenable to curative therapy.
-Patient has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PgRpositive breast cancer based on the most recently
analyzed tissue sample, and all tested by local laboratory.
-Patient has 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 and based on the most recently analyzed tissue sample.
-Patient must have measurable disease, i.e., at least one measurable lesion according to RECIST version 1.1. (a lesion in a previously irradiated site may only be counted as a target lesion if there is clear evidence of progression since the irradiation).
-Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
-Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the central
laboratory:
QTc interval at screening < 450 ms (using Fridericia’s correction)
Mean resting heart rate 50 to 90 bpm (determined from the ECG)
-Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must
have confirmed negative serum pregnancy test (for ß-hCG) within 14 days prior to randomization.
Women of CBP must be willing to use highly effective methods of contraception.

Please refer to Section 5.1 of the protocol for full details on inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 263
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 87

Exclusion Criteria

-Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator’s judgment.
-Patient who received any prior systemic anti-cancer therapy (including endocrine therapy, chemotherapy, prior CDK4/6 inhibitors) for aBC.
Patients who received neo-/adjuvant therapy for breast cancer are eligible.
-Patient is concurrently using other anti-cancer therapy.
-Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major toxicities.
-Patient has received extended-field radiotherapy = 4 weeks or limited field radiotherapy = 2 weeks prior to randomization, and 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 has a concurrent malignancy or malignancy within 3 years of the randomization date, with the exception of adequately treated basal or squamous cell skin carcinoma, or curatively resected cervical carcinoma in situ.
-Patients with central nervous system (CNS) involvement unless they meet specific stability criteria.
-Patient has clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
-Patient is currently receiving or has received systemic corticosteroids = 2 weeks prior to starting study drug, and has not fully recovered from side effects of such treatment.

Please refer to Section 5.2 of the protocol for details on exclusion criteria.

Study & Design

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