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: 20.1Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10073289Term: Premenopausal breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Last Update Posted: 30 June 2019

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.
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.
i)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
-Other protocol-defined inclusion/exclusion may apply.

Study & Design

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