Sac-TMT for Active TNBC Brain Metastases

Conditions

• Metastatic Triple Negative Breast Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Sacituzumab tirumotecan — DRUG
  Sacituzumab tirumotecan should begin within three days of registration. For all study interventions administered based on weight, the participant's weight at screening or at cycle 1, day 1 should be used to calculate the initial dose. The participant's weight will be determined before each dose of sacituzumab tirumotecan. If, at any time throughout the course of treatment, the participant's weight changes by ≥10% from baseline, the dose will be recalculated using this new weight and will be considered the new baseline for all subsequent dosing calculations. The dose(s) of study intervention(s) should be recalculated as needed throughout the study. Dose adjustments for changes in body weight \<10% are permitted per institutional standards. Sacituzumab tirumotecan will be administered by IV infusion on days 1, and 15 of each 28-day cycle. The duration of the sacituzumab tirumotecan infusions should be 90 minutes (±15 minutes), and infusion-related AEs will be monitored.

Study Details

This is a multi-site prospective single-arm open-label phase 2 clinical trial including 20 participants with metastatic TNBC and active brain metastases to be treated with sacituzumab tirumotecan 4 mg/kg IV on Days 1, and 15 of every 28-day cycle until disease progression, unacceptable toxicities, consent withdrawal, or death.

Key Dates

Start date

May 31, 2026

Status verified

Mar 2026

Primary completion

May 31, 2028

Completion

May 31, 2029

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Sacituzumab tirumotecan
  Sacituzumab tirumotecan will be administered by IV infusion on days 1, and 15 of each 28-day cycle. The duration of the sacituzumab tirumotecan infusions should be 90 minutes (±15 minutes), and infusion-related AEs will be monitored.

Primary Outcome Measure

Intracranial response rate determined by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) in patients with metastatic triple-negative breast cancer and brain metastases. [ Time Frame: At screening and every 8 weeks during the treatment period (up to one year) ]

Central Contacts

• Laura Kane
  773-369-6904
  [email protected]

Locations (1)

Find similar trials in New Haven, CT

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