Trial Outcomes & Findings for A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib (NCT NCT03050398)

Results Overview

Mutations of genes that were relevant to HR+ and the CDK4/6 pathway such as but not limited to CCND1, CDKN2A, PIK3CA and PTEN to identify the potential mechanisms of progression.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

8 participants

Primary outcome timeframe

Baseline, time of progression approximately 24 months

Results posted on

2020-05-28

Participant Flow

All patients had to have met all eligibility criteria and to have been enrolled into the CLEE011A2404 core study. Patients were offered the opportunity to consent and enroll into this optional companion study.

Participant milestones

Participant milestones
Measure	Ribociclib + Letrozole ribociclib with letrozole
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Ribociclib + Letrozole ribociclib with letrozole
Overall Study Study terminated by sponsor	8

Baseline Characteristics

A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ribociclib + Letrozole n=8 Participants ribociclib with letrozole
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	6 participants n=5 Participants
Race/Ethnicity, Customized Black	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, time of progression approximately 24 months

Population: No samples were analyzed

Mutations of genes that were relevant to HR+ and the CDK4/6 pathway such as but not limited to CCND1, CDKN2A, PIK3CA and PTEN to identify the potential mechanisms of progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, time of progression approximately 24 months

Population: No samples were analyzed

Change in mutations would have been assessed based on baseline samples and compared across diverse races/ethnicities with HR+ HER2- advanced breast cancer - specifically Caucasian, African America, Hispanic, Native American and Pacific Islander.

Outcome measures

Outcome data not reported

Adverse Events

Ribociclib + Letrozole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 888-669-6682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER