Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy

Conditions

• HER2 Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ribociclib 400mg — DRUG
  400 mg (2 x 200 mg tablets by mouth) once daily on days 1 to 21 of a 28-day cycle, followed by seven days off ribociclib (Days 22 to 28).
• Letrozole 2.5mg — DRUG
  Letrozole will be administered as an endocrine therapy. The regimen will differ depending on the demographic of the patient. For postmenopausal women: Letrozole 2.5 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously.
• Anastrazole 1mg — DRUG
  For postmenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously.
• Goserelin 3.6 MG — DRUG
  For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, concurrently with goserelin 3.6 mg monthly injection.
• Adjuvant chemotherapy — RADIATION
  Adjuvant chemotherapy dose modifications in Arm 2 will be per institutional guidelines and investigator discretion.

Study Details

This is a Phase II, two-arm, single center, patient preference study designed to evaluate the impact of omitting adjuvant chemotherapy in moderate to high-anatomical risk, low-genomic risk (men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and RS 26-30, or T1-3N1 and RS 26-30, or T1-3N2 and RS ≤ 25),

Key Dates

Start date

Jul 9, 2025

Status verified

May 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ribociclib + Optimized Endocrine Therapy
  Combination of ribociclib and optimized endocrine therapy
• Experimental: Adjuvant Chemotherapy + Ribociclib & Optimized Endocrine Therapy
  Adjuvant chemotherapy followed by a combination of ribociclib and optimized endocrine therapy

Primary Outcome Measure

Discontinuation rate of ribociclib in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer [ Time Frame: Within one year of treatment ]

Central Contacts

• Stephanie Ladd
  954-895-0576
  [email protected]

Locations (1)

Find similar trials in New Haven, CT

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