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: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10073289Term: Premenopausal breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-22
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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 PgR-positive 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:
- QTcF interval at screening < 450 ms (QT interval 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