ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Hormone Receptor-positive Breast Cancer; Metastatic Breast Cancer; HER2-negative Breast Cancer; Recurrent Breast Cancer

Treatments: Drug: letrozole; Drug: abemaciclib; Drug: ONO-4578; Drug: Palbociclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06570031

ONO-4578-06

Details and patient eligibility

About

This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, HER2-negative breast cancer.

Enrollment: 46 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with postmenopausal metastatic or recurrent breast cancer
2. Patients with ECOG Performance Status 0 to 1
3. ER-positive, PgR-positive and HER2-negative patients

Exclusion criteria

1. Patients are unable to swallow oral medications
2. Patients with severe complication

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

ONO-4578 + letrozole + palbociclib

Experimental group

Treatment:

Drug: Palbociclib

Drug: ONO-4578

Drug: letrozole

ONO-4578 + letrozole + abemaciclib

Experimental group

Treatment:

Drug: ONO-4578

Drug: abemaciclib

Drug: letrozole