About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

An individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent.

Individuals who are unable to provide informed consent may be included if a Legally Authorized Representative (LAR) is available and able to provide consent on their behalf.

Histologically and/or cytologically confirmed metastatic triple-negative breast cancer defined by estrogen receptor (ER) expression <10%, progesterone receptor expression <10% and HER2-negative status, defined by 0, 1+ or 2+ FISH negative by immunohistochemistry (IHC) by standard pathology.

Newly diagnosed untreated brain metastases or brain metastases progressing after prior local therapy (including surgery and/or radiation therapy).

Disqualifiers

Prior use of sacituzumab tirumotecan.

Known hypersensitivity to sacituzumab tirumotecan or any of the drug components

Other concomitant anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates.

A history of uncontrolled seizures (more than two seizures within 28 days prior to registration), CNS disorders, or psychiatric disability judged by the treating investigator to be clinically significant and adversely affecting compliance with study drug.

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Sacituzumab tirumotecanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

To determine the intracranial efficacy of sacituzumab tirumotecan in patients with metastatic triple-negative breast cancer and brain metastases. RANO-BM evaluates treatment response by categorizing results into Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)

Time frame

At screening and every 8 weeks during the treatment period (up to one year)

Secondary outcomes

1

Intracranial clinical benefit rate by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) in patients with metastatic triple-negative breast cancer and brain metastases.

To determine the intracranial and extracranial efficacy of sacituzumab tirumotecan in patients with metastatic triple-negative breast cancer and brain metastases. RANO-BM evaluates treatment response by categorizing results into Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).

Time frame

At baseline and every 8 weeks during the treatment period (up to 1 year)

2

Extracranial objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in patients with metastatic triple-negative breast cancer and brain metastases

To determine the intracranial and extracranial efficacy of sacituzumab tirumotecan in patients with metastatic triple-negative breast cancer and brain metastases. The RECIST 1.1 scale assesses cancer treatment response in clinical trials. It defines four response categories-Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD)-based on the sum of the longest diameters of target lesions.

Time frame

At baseline and every 8 weeks during the treatment period (up to 1 year)

3

Extracranial clinical benefit rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in patients with metastatic triple-negative breast cancer and brain metastases

To determine the intracranial and extracranial efficacy of sacituzumab tirumotecan in patients with metastatic triple-negative breast cancer and brain metastases. The RECIST 1.1 scale assesses cancer treatment response in clinical trials. It defines four response categories-Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD)-based on the sum of the longest diameters of target lesions.

Time frame

At baseline and every 8 weeks during the treatment period (up to 2 years)

4

Intracranial progression-free survival in patients with metastatic triple-negative breast cancer and brain metastases

To determine the survival benefit of sacituzumab tirumotecan in patients with metastatic triple-negative breast cancer and brain metastases.

Time frame

Every 12 weeks during the survival follow up phase (until death or lost to follow up. Participants will be followed for up to 1 year after completing or stopping protocol treatment)

Sac-TMT for Active TNBC Brain Metastases

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts