Breast CancerPhase 1/2NCT06238921
Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases
A Phase 1/2 study testing Stereotactic Radiation, Zimberelimab and Sacituzumab govitecan in people with Breast Cancer and Triple Negative Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Stereotactic Radiation, Zimberelimab and Sacituzumab govitecan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to Feb 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- Myocardial infarction or unstable angina pectoris within 6 months of enrollment
- History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation
- New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kamran Ahmed, MD contact
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Michelle DeJesus, 813-745-6911, Michelle.DeJesus@moffitt.org
Kamran Ahmed, MD
About this study
Official title: Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)
This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Stereotactic Radiation, Zimberelimab, Sacituzumab govitecan
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiationRadiation
Stereotactic Radiation to intact brain metastases or post-operative cavity.
ZimberelimabDrug
One week +/- 4 days following receipt of SRS, zimberelimab 360 mg IV will be administered. This will be followed by zimberelimab 360 mg IV every 3 weeks.
Sacituzumab govitecanDrug
Also called Trodelvy
SG will be administered on days 1 and 8 (10 mg/kg) of 21 day treatment cycles. This will be one week +/- 4 days following receipt of SRS for the first dose.
| Study group | Role | What they receive |
|---|---|---|
| SG + Zimberelimab with SRS | Experimental | Treatment will be initiated with SRS followed 1 week later by SG on days 1 and 8 (10mg/kg) with zimberelimab on day 1 (360 mg IV) repeated every 3 weeks follow-up imaging response assessments will be conducted at q9 week intervals. Receives: Radiation: Stereotactic Radiation; Drug: Zimberelimab; Drug: Sacituzumab govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Neurologic Toxicity
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
Measured: Up to 9 Weeks
Phase II: Progression Free Survival (PFS)
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.
Measured: Up to 12 Months
Secondary outcomes (5)
Phase II: Intracranial Progression Free Survival (PFS)
Time from the date of start of treatment to the investigator-determined date of progression (determined by Response Assessment in Neuro-Oncology (RANO)) or death due to any cause, whichever occurs first.
Progression is measured by a ≥ 20% increase in sum longest distance relative to nadir in target lesions and unequivocal or progressive disease in non-target lesions.
Measured: Up to 12 Months
Phase II: Extracranial Progression Free Survival (PFS)
PFS will be measured from the date of start of treatment to the investigator-determined date of progression (determined by Immune-related Response Evaluation Criterial in Solid Tumors (irRECIST)) or death due to any cause, whichever occurs first.
Progression is defined as ≥ 20% increase in tumor burden.
Measured: Up to 33 Months
Phase II: Overall Survival (OS)
OS will be measured from the date of start of treatment to death.
Measured: Up to 33 Months
Phase II: Local Brain Control
Number of participants with Local Brain Control will be determined from irradiated lesions according to RANO criteria.
Measured: Up to 33 Months
Phase II: Distant Brain Control
Number of participants with Distant Brain Control will be determined by the development of new lesions outside the irradiated area.
Measured: Up to 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start19 Dec 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Kamran Ahmed, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238921
- Sponsor's protocol ID
- MCC-21676
- Status last verified
- Dec 2025
- First submitted
- 25 Jan 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)
- ClinicalTrials.gov ID
- NCT06238921
- Acronym / sponsor ID
- MCC-21676
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SG + Zimberelimab with SRS | Experimental | Radiation: Stereotactic Radiation, Drug: Zimberelimab, Drug: Sacituzumab govitecanTreatment will be initiated with SRS followed 1 week later by SG on days 1 and 8 (10mg/kg) with zimberelimab on day 1 (360 mg IV) repeated every 3 weeks follow-up imaging response assessments will be conducted at q9 week intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic RadiationStereotactic Radiation to intact brain metastases or post-operative cavity. | Radiation | SG + Zimberelimab with SRS |
| ZimberelimabOne week +/- 4 days following receipt of SRS, zimberelimab 360 mg IV will be administered. This will be followed by zimberelimab 360 mg IV every 3 weeks. | Drug | SG + Zimberelimab with SRS |
| Sacituzumab govitecanAlso: TrodelvySG will be administered on days 1 and 8 (10 mg/kg) of 21 day treatment cycles. This will be one week +/- 4 days following receipt of SRS for the first dose. | Drug | SG + Zimberelimab with SRS |
Primary outcome
Phase I: Neurologic Toxicity
Time frame: Up 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)
Time frame: 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.
5 secondary outcomes
Phase II: Intracranial Progression Free Survival (PFS)
Time frame: Up to 12 Months
Phase II: Extracranial Progression Free Survival (PFS)
Time frame: Up to 33 Months
Phase II: Overall Survival (OS)
Time frame: Up to 33 Months
Phase II: Local Brain Control
Time frame: Up to 33 Months
Phase II: Distant Brain Control
Time frame: Up to 33 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kamran Ahmed, MD contact
Kamran Ahmed, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic Radiation, Zimberelimab and Sacituzumab govitecan in people with Breast Cancer and Triple Negative Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle DeJesus (813-745-6911, Michelle.DeJesus@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Neurologic Toxicity (time frame: Up to 9 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.