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Sacituzumab Govitecan and Zimberelimab with Radiation for Metastatic Triple Negative Breast Cancer with Brain Metastases

This study is testing a combination of treatments for metastatic triple negative breast cancer that has spread to the brain. It's looking at the safety and effectiveness of Sacituzumab Govitecan and Zimberelimab, along with Stereotactic Radiation (SRS), compared to Sacituzumab Govitecan alone. You might be able to join if you are at least 18 years old and have triple negative breast cancer that has spread to your brain. The study aims to see how well this combination controls the cancer (Progression Free Survival) and if there are any serious side effects (Neurologic Toxicity). This study is currently recruiting about 31 participants, but the exact status is unclear.

Study design
This is a Phase I/II study, meaning it will first look at safety and then at how well the treatment works. It will involve about 31 participants.
What's involved
Sacituzumab Govitecan will be given on days 1 and 8 of 21-day cycles. Zimberelimab will be given every 3 weeks, starting about one week after Stereotactic Radiation (SRS).
Compensation
Not stated in the trial record.
Follow-up
The study will measure neurologic toxicity for up to 9 weeks and progression-free survival for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06238921

Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

Recruiting
PHASE1Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~31 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:Stereotactic RadiationZimberelimabSacituzumab govitecan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Neurologic Toxicity
Measured over Up to 9 Weeks
+1 more outcome measured

Conditions

Breast Cancer
Triple Negative Breast Cancer

Explore related trials

Triple-negative breast cancer

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Kamran Ahmed, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Michelle DeJesus
[email protected]
813-745-6911
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated Informed Consent Form (ICF).
Stated willingness to comply with all study procedures and availability for the duration of the study.
Age ≥ 18.
Triple negative breast cancer; to fulfill the requirement of triple negative disease, a breast cancer must express (≤ 10%), by immunohistochemistry (IHC), of the hormone receptors (estrogen receptor \[ER\] and progesterone receptor \[PR\]).
Breast cancer as documented by extracranial tumor biopsy with brain metastases documented from MRI brain imaging or intracranial surgical pathology.
Eligible for Stereotactic radiosurgery (SRS) to brain metastases or to the post-operative bed.
Measurable brain disease per RANO-BM criteria1 that can be measured in at least one dimension as ≥ 0.5 cm for both intact brain metastases and post-operative cavities.
Maximum diameter of the largest intact brain metastases ≤ 4 cm.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Symptomatic patients having undergone surgery or on stable doses of steroids ≤ 8 mg/day dexamethasone will be enrolled.
Prior treatment with taxane based chemotherapy with anthracyclines.
Individuals with prior SRS/fractioned stereotactic radiotherapy (FSRT) treatment will be allowed if active measurable disease has not previously been treated with radiation therapy.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the administration of each dose of study agent.
Male and female patients of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.

Exclusion

Presence of leptomeningeal disease.
Women who are pregnant or breastfeeding.
Known history of HIV-1 or 2 with detectable viral load.
Active, known, or suspected autoimmune disease. Patients with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded. Exceptions are patients with type I diabetes mellitus, hypothyroidism only requiring thyroid replacement therapy, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Met any of the following criteria for cardiac disease:
Any patient requiring supplemental oxygen therapy.
Have an active serious infection requiring antibiotics.
Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.
Patients with prior history of non-breast cancer malignancies are excluded except in the case of adequately treated basal cell cancer, squamous cell skin cancer, chronic lymphocytic leukemia, or other cancers in remission not receiving active therapy for ≥ 2 years.
Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or that would interfere with the interpretation of safety results.
Major surgery or significant traumatic injury that has not been recovered from by 14 days before the initiation of study drug.
Have had a prior anticancer biologic agent within 4 weeks prior to enrollment or have had prior chemotherapy, targeted small molecule therapy within 2 weeks prior to enrollment and have not recovered.
Have previously received topoisomerase 1 inhibitors in the setting of brain metastases.
Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.
Have active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
History of allergy or hypersensitivity to any of the study drugs or study drug components.
Prisoners or individuals who are involuntarily incarcerated.
Individuals who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

What this trial measures

  • Phase I: Neurologic ToxicityUp to 9 Weeks

    Neurologic Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5). A Neurologic Toxicity will be defined as any Grade 3 or higher toxicity that occurs during the Dose Limiting Toxicity evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition. * Symptomatic radionecrosis, defined by surgical pathology or multidisciplinary evaluation. * Grade ≥ 3 headaches * Grade ≥ 3 memory impairment * New onset grade ≥ 3 seizures

  • Phase II: Progression Free Survival (PFS)Up to 12 Months

    Evaluate the PFS of SG and zimberelimab with SRS among patients with metastatic triple negative breast cancer. PFS is time from the date of start of treatment to the investigator-determined date of progression or death due to any cause, whichever occurs first.