Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Trial Title: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

NCT ID: NCT05827081

Condition: Early Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Letrozole
Leuprolide
Exemestane
Goserelin

Conditions: Keywords:
HR+
HER2-
EBC
Early breast cancer
Premenopausal
Postmenopausal
Male breast cancer
Ribociclib
LEE011
NSAI
ET
Endocrine therapy
Goserelin

Study type: Interventional

Study phase: Phase 3

Overall status: Suspended

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Ribociclib
Description: Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
Arm group label: Ribociclib + endocrine therapy

Intervention type: Drug
Intervention name: Letrozole
Description: Letrozole 2.5 mg orally once daily continuously
Arm group label: Ribociclib + endocrine therapy

Intervention type: Drug
Intervention name: Ansastrozole
Description: Anastrozole 1 mg orally once daily continuously.
Arm group label: Ribociclib + endocrine therapy

Intervention type: Drug
Intervention name: Goserelin
Description: Goserelin administered subcutaneously at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used
Arm group label: Ribociclib + endocrine therapy

Intervention type: Drug
Intervention name: Leuprolide
Description: Leuprolide administered subcutaneously at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used
Arm group label: Ribociclib + endocrine therapy

Intervention type: Drug
Intervention name: Exemestane
Description: Exemestane 25 mg once daily continuously
Arm group label: Ribociclib + endocrine therapy

Summary: An open-label, multicenter, phase IIIb, single-arm study to evaluate the safety and efficacy of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a wide patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, II (subset) or I (high-risk subset as exploratory cohort) early Breast Cancer (EBC)

Criteria for eligibility:
Criteria:
Key Inclusion Criteria: - 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 enrollment should occur within 36 months of prior ET start date and the participant should have at least 3 years remaining of endocrine adjuvant therapy. For participants with prior ET treatment > 12 months, the investigator should rule out disease recurrence prior to enrollment. The number of participants with prior ET between 12 and 36 months will be capped at 1000. - Participant has no contraindication for the adjuvant ET in the study. - Participant after complete surgical resection with the final surgical specimen microscopic margins free from tumor and in one of below categories: - Anatomic Stage Group III - Anatomic Stage Group II (subset) - Anatomic Stage Group I (high-risk subset as exploratory cohort) - Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2. - Participant has adequate bone marrow and organ function. Key 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. Other inlcusion/exclusion criteria may apply

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Novartis Investigative Site

Address:
City: Gateshead
Zip: 2290
Country: Australia

Start date: February 28, 2024

Completion date: September 20, 2030

Lead sponsor:
Agency: Novartis Pharmaceuticals
Agency class: Industry

Source: Novartis

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05827081