Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

About the study

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).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:

Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC).
Participant has HER2-negative breast cancer.
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.
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).

EXCLUSION CRITERIA

Key Exclusion Criteria:

Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.
Participant has any other concurrent severe and/or uncontrolled medical condition.
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.

Other inclusion/exclusion criteria may apply