Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (Adjuvant WIDER)

Novartis

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Early Breast Cancer

Treatments: Drug: Goserelin; Drug: Ansastrozole; Drug: Ribociclib; Drug: Letrozole; Drug: Leuprolide; Drug: Exemestane

Study type: Interventional

Funder types: Industry

Identifiers

NCT05827081

CLEE011O12001

Details and patient eligibility

About

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)

Enrollment: 3,100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,100 participants in 1 patient group

Ribociclib + endocrine therapy

Experimental group

Description:

Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy (ET) for 36 months (approximately 39 cycles). ET consists of: * For postmenopausal women: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously. * For pre/perimenopausal women, and men: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously, combined with goserelin 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) or leuprolide 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)

Treatment:

Drug: Exemestane

Drug: Leuprolide

Drug: Letrozole

Drug: Ansastrozole

Drug: Ribociclib

Drug: Goserelin