Asciminib in HER2+ Breast Cancer Brain Metastases

Conditions

• HER2+ Metastatic Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Asciminib and Trastuzumab — COMBINATION_PRODUCT
  Each study treatment cycle will last 21 days. Asciminib will be taken orally every day during the treatment period at the dose determined as the MTD during the safety lead-in in combination with trastuzumab at a standard dose of 6mg/kg IV. Asciminib dose will begin at 80 mg daily (dose level 1), with a potential range from 40 mg daily (dose level -1A, with trastuzumab) to 200 mg bid (dose level 3, with trastuzumab) depending on the results of the safety lead-in. Trastuzumab will be given intravenously (IV) or subcutaneously (SQ) on Day 1 of each 21 day cycle.

Study Details

The purpose of this study is to evaluate the intracranial response rate of a combination of asciminib/trastuzumab for the treatment of patients with metastatic HER2+ breast cancer with brain metastases.

Key Dates

First listed

Aug 22, 2025

Start date

Jul 7, 2026

Status verified

Jul 2026

Primary completion

Nov 1, 2030

Completion

Nov 1, 2032

Study Design

Enrollment

42 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Asciminib Trastuzumab
  Combination of asciminib and trastuzumab

Primary Outcome Measure

Number of participants with a dose-limiting toxicity at each dose level [ Time Frame: Day 1 of treatment until 30 days post last dose ]

Central Contacts

• Carey Anders, MD
  919-471-8344
  [email protected]
• Breast Clinic
  919-660-1278
  [email protected]

Locations (1)

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