Clinical trial NCT03050398: A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
Official title: A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: HR-positive
HER2-negative
Advanced breast cancer
LEE011
ribociclib
letrozole
femara
CDK
CDK4
CDK6
CDK4/6
CDK4/6 inhibitor
Phase III
Phase IIIb
ER-positive
PR-positive
Postmenopausal
Premenopausal
Men
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-02-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.

Detailed description: This was a multicenter, non-treatment based companion sample collection protocol conducted in the US only. This protocol sought to evaluate the aberrations of common pathways for newly diagnosed HR+/HER2- advanced breast cancer tumors and responses to ribociclib in diverse patient populations. This companion sample collection protocol was available for all US patients enrolled on CLEE011A2404 (CompLEEment-1) and did not alter the planned treatment. Tumor collection required for this study occurred at two time points: at baseline/screening and upon the development of progressive disease as shown in the protocol. Patients eligible for this companion study were required to sign an optional additional consent form at the time of enrolling into the core trial.

After eight patients had consented and samples had been taken, it was determined that the companion study protocol had not been properly initiated or monitored at the sites. This was determined to be a significant GCP violation and the clinical team made the decision to terminate the trial. In addition to the GCP issues, enrollment had been closed to the core study so enrolling additional patients was no longer possible. The limited number of samples would not provide any meaningful analysis. The samples were never analyzed. The study was not terminated due to safety or efficacy concerns. Samples collected were either destroyed or will be retained for up to 15 years based upon the decision of the patient.

Eligibility criteria: Inclusion Criteria:

* Written informed consent was to have been obtained prior to any baseline/screening procedures.
* Patients eligible for this companion sample collection protocol sample collection protocol must have met all inclusion in CLEE011A2404.

Exclusion Criteria:

* Patients eligible for this companion sample collection protocol must not have met any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:
* Patients without either fresh or archival tumor tissue accessible.

Primary outcomes:
measure: Identify Mutations of Genes From Tissue Samples Between Baseline and Time to Progression to Determine Modes of Resistance to Ribociclib After Disease Progression
timeFrame: Baseline, time of progression approximately 24 months
Secondary outcomes:
measure: Compare the Differences in Mutations Across Various Races / Ethnicities Based on Baseline Samples
timeFrame: Baseline, time of progression approximately 24 months
Other outcomes:
Locations:
city: Sedona
country: United States
facility: Arizona Oncology Associates PC HAL
state: Arizona
city: Long Beach
country: United States
facility: Pacific Shores Medical Group SC
state: California
city: Charlotte
country: United States
facility: Oncology Speciialists of Charlotte
state: North Carolina
city: Florence
country: United States
facility: McLeod Center for Cancer Treatment and Research
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care of South Carolina
state: South Carolina
city: Bellingham
country: United States
facility: PeaceHealth St Joseph Medical Center
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: