Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2030-06-28
• Target enrollment: 0
• Participant gender: All

Summary

A open-label, multicenter, phase IIIb, single-arm trial is to evaluate the efficacy of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in close to real world patient population with HR-positive, HER2-negative, Anatomic Stage Group III, IIB or a subset of Stage IIA early Breast Cancer (EBC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Goserelin; Letrozole; Leuprolide

Criteria

Inclusion Criteria:

• Participant is an adult, male or female ≥ 18 years of age at the time of informed consent signature.

• Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer

• 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 enrolment should occur within 24 months and the participant has at least 3 years remaining of endocrine adjuvant therapy.

• Participant is allowed up to 24 months of prior ET with a capping of 1000 participants who have taken prior ET between 12 and 24 months prior to first study treatment (C1D1). Participant should have at least 3 years remaining of planned ET at first treatment dose (C1D1).

• Patient 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 II or III.

• Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2.

• Participant has adequate bone marrow and organ function.

Exclusion Criteria:

• Participant with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.

• Participant is concurrently using other anti-neoplastic 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.