Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Breast Cancer
Unknown Primary
18 - 100 Years, Male and Female
CLEE011O12001 (primary)
NCI-2025-04264
2022-503001-38-00
Summary
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to
characterize the efficacy and safety of the combination of ribociclib and standard
adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a
close to clinical practice patient population with HR-positive (HR+), HER2-negative
(HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer
(EBC).
Objectives
The study consists of Screening, Treatment, and Follow-up periods.
- Treatment Period: all participants who complete screening will receive ribociclib
400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with
daily ET for 36 months (approximately 39 cycles) from the date of first dose. The
Treatment Period starts when the patient receives their first dose of ribociclib and
ends at the time of the 30-day Safety Follow-up. All treated participants should
have a Safety Follow-up call conducted 30 days after the last dose of study
treatment.
- Follow-up period: participants will be followed from 30 days after study treatment
(i.e., ribociclib) completion/discontinuation (i.e. 30-day Safety Follow-up) until
death, withdrawal of consent, lost to follow-up, or until 48 months after the last
participant has received their first dose of study treatment (i.e. End of Study
[EOS]), whichever occurs first.
Eligibility
- Participant is an adult, male or female = 18 years of age at the time of informed consent form signature (IC).
- Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.
- Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (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 based on the most recently analyzed tissue sample.
- Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.
- For participants with prior ET treatment > 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.
- The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.
- Participant has no contraindication to receive adjuvant ET in the study.
- Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:
- Anatomic Stage Group III, or
- Anatomic Stage Group IIB, or
- A subset of Anatomic Stage Group IIA.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
- Participant has adequate bone marrow and organ function.
- ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:
- QTcF interval at Screening < 450 msec (QT interval using Fridericia's correction).
- Mean resting heart rate 50-99 beats per minute (determined from the ECG). Key
Treatment Sites in Georgia
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