Metastatic Breast CancerPhase 2STORMNCT07368543
Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer
A Phase 2 study testing Sacituzumab Govitecan and Trastuzumab Deruxtecan in people with Metastatic Breast Cancer, run by Fudan University.
Trial summary
Currently, no phase III RCT has directly compared SG and T-DXd sequencing strategies, and the predictive role of biomarkers remains unclear. Additionally, there is no standard scoring system for Trop-2 expression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Sacituzumab Govitecan and Trastuzumab Deruxtecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2026to 1 Dec 2028
- Phase
- Phase 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
- Patients who meet all of the following criteria are eligible for inclusion in this study:
- Male or female, age ≥18 years.
- ECOG performance status ≤2, with an estimated life expectancy of >3 months.
- Histologically confirmed unresectable or metastatic breast cancer that is:HER2 IHC 1+ triple-negative breast cancer, or HR-positive/HER2-ultralow or HER2 IHC 1+ breast cancer.
- Planned to receive monotherapy with Sacituzumab Govitecan and Trastuzumab Deruxtecan.
- For triple-negative breast cancer: prior systemic therapy lines ≥1.
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- For HR-positive/HER2-negative metastatic breast cancer: prior endocrine therapy is required. Prior chemotherapy, immunotherapy, or targeted therapy is allowed; 0-2 lines of chemotherapy in the advanced/metastatic setting are permitted.
- Prior treatment-related adverse events have recovered to ≤Grade 1 per NCI CTCAE v5.0 (except for alopecia, non-clinically significant or asymptomatic laboratory abnormalities).
- Presence of at least one measurable or evaluable lesion.
- Willingness to provide archival or fresh tumor tissue samples for multi-omics analysis, including:
- Baseline prior to ADC1 treatment,
- After 2 cycles of ADC1 therapy,
- At progression on ADC1 therapy or baseline prior to ADC2 therapy,
- At progression on ADC2 therapy.
- FFPE tissue blocks are preferred over unstained slides. Patients must consent to tumor biopsy; if tissue is unavailable, biopsy is not feasible, or the patient declines biopsy, eligibility may be discussed and approved by the investigator.
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50% within 28 days before treatment.
- Adequate organ function within 7 days prior to treatment initiation:
- Bone marrow: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L (no transfusion or blood component use within 14 days before first dose; no growth factor support within 7 days before first dose).
- Liver: total bilirubin ≤1.5 × ULN (or <3 × ULN if Gilbert's syndrome or documented liver metastases present); ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present).
- Renal: serum creatinine ≤1.5 × ULN OR creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula).
- Coagulation: INR ≤1.5 × ULN and aPTT ≤1.5 × ULN (unless therapeutically anticoagulated).
- Voluntarily signed informed consent form and willingness to comply with the study protocol.
- Willingness to provide complete clinical medical record data.
Who cannot join
- Patients meeting any of the following criteria will be excluded from the study:
- Contraindication or known hypersensitivity to sacituzumab govitecan, trastuzumab deruxtecan, or any of their components (including topoisomerase I inhibitors).
- Prior treatment with sacituzumab govitecan, trastuzumab deruxtecan, or any other drug targeting the same molecular pathway.
- History of another primary malignancy, except for:
- Malignancy treated with curative intent with no evidence of active disease for ≥2 years prior to study intervention and with low risk of recurrence, or
- Adequately treated carcinoma in situ of the cervix, stage I endometrioid carcinoma of the uterus, or non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma).
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- Active infection or uncontrolled systemic disease, including but not limited to:
- Active HIV, HBV, or HCV infection,
- Active autoimmune disease,
- Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage,
- Severe or uncontrolled cardiac disease requiring treatment,
- Poorly controlled diabetes or hypertension despite medical therapy.
- Participation in another investigational drug trial within 4 weeks prior to the first study treatment (observational studies are permitted) or major surgery within 4 weeks prior to the first study treatment.
- Prior anticancer therapy within specified timeframes:
- Chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 4 weeks before the first study treatment,
- Anticancer endocrine therapy or traditional Chinese medicine with antitumor intent within 2 weeks before the first study treatment.
- History of or current interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, or other clinically significant pulmonary disorders.
- Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at baseline; patients (male or female) who are unwilling to use effective contraception throughout the study period.
- Known neurological or psychiatric disorders (e.g., epilepsy, dementia) or cognitive impairment that would compromise understanding of the study objectives, compliance, or ability to provide informed consent; or significant peripheral neuropathy.
- Primary central nervous system (CNS) tumor or untreated/symptomatic CNS metastases. Patients with asymptomatic, stable CNS metastases not requiring steroids or specific CNS-directed therapy for at least 4 weeks prior to screening may be eligible.
- Any other condition deemed unsuitable for participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sequencing Sacituzumab Govitecan vs. Trastuzumab Deruxtecan in HER2-LOw/TROP2-High Metastatic Breast Cancer: A Randomized Phase II Study
Currently, no phase III RCT has directly compared SG and T-DXd sequencing strategies, and the predictive role of biomarkers remains unclear. Additionally, there is no standard scoring system for Trop-2 expression. The ASCENT trial utilized an H-score method (H-score = 3×%IHC3+ + 2×%IHC2+ + 1×%IHC1+), with scores <100, 100-200, and >200 defining low, medium, and high Trop-2 expression, respectively.This prospective study aims to: 1) Evaluate the efficacy of SG vs. T-DXd in HER2-low/Trop-2-high metastatic breast cancer, prioritizing SG for Trop-2-high patients and T-DXd for others. 2) Compare sequential treatment outcomes-T-DXd after SG failure versus SG after T-DXd failure-to inform ADC sequencing in HER2-low disease. Up to one intervening therapy is allowed before sequencing. 3) Identify biomarkers of ADC efficacy and resistance through quantitative protein analysis to optimize patient selection.
Read the detailed description
This investigator-initiated study aims to evaluate the efficacy of sequential treatment with sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) in patients with HER2 IHC 1+ /Trop-2-high metastatic breast cancer. It will also explore the correlation between changes in tumor-associated protein expression levels and ADC efficacy, and investigate mechanisms of ADC resistance.
The study will establish a multicenter cohort of patients treated with SG/T-DXd:
Cohort A (Triple-Negative Breast Cancer, TNBC): Includes patients with unresectable locally advanced or metastatic triple-negative breast cancer (HER2 IHC 1+) who have received ≥1 prior line of systemic therapy for metastatic disease. Prior to enrollment, all patients will undergo Trop-2 expression testing. Patients identified as Trop-2-high will be randomized 1:1 to either:SG Treatment (Trop-2 Group), orT-DXd Treatment (HER2 Group). The initially administered ADC is designated as ADC1. Upon disease progression, patients may cross over to receive the other ADC as sequential therapy (designated as ADC2). One intervening non-ADC therapy (e.g., targeted therapy, chemotherapy) is permitted prior to cross-over. Randomization will maintain a 1:1 allocation between the Trop-2 and HER2 groups.
Cohort B (HR+/HER2-ultralow or HER2 IHC 1+ Breast Cancer): Includes patients with unresectable locally advanced or metastatic HR+/HER2-ultralow or HER2 IHC 1+ breast cancer who have progressed on prior endocrine therapy. Prior to enrollment, all patients will undergo Trop-2 expression testing. Patients identified as Trop-2-high will be randomized 1:1 to either:SG Treatment (Trop-2 Group), orT-DXd Treatment (HER2 Group).
Upon progression, patients may cross over to receive the other ADC as sequential therapy. One intervening non-ADC therapy (e.g., targeted therapy, chemotherapy) is permitted prior to cross-over. Randomization will maintain a 1:1 allocation between the Trop-2 and HER2 groups.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Sacituzumab Govitecan, Trastuzumab Deruxtecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab GovitecanDrug
Recommended Dose: 10 mg/kg administered by intravenous infusion on Days 1 and 8 of each 21-day treatment cycle. Continue treatment until disease progression or unacceptable toxicity.
Trastuzumab DeruxtecanDrug
Dosage and Administration: The recommended dose is 5.4 mg/kg administered by intravenous infusion once every 3 weeks (21-day cycles). Continue treatment until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Triple-Negative Breast Cancer) | Experimental | Patients with HER2 IHC 1+ metastatic triple-negative breast cancer (TNBC); Receives: Drug: Sacituzumab Govitecan; Drug: Trastuzumab Deruxtecan |
| Cohort B (HR+/HER2 IHC 1+ and Ultralow Metastatic Breast Cancer) | Experimental | Patients with HR-positive/HER2 IHC 1+ and HER2 ultralow metastatic breast cancer (MBC) who have failed endocrine therapy. Receives: Drug: Sacituzumab Govitecan; Drug: Trastuzumab Deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival 1 (PFS1)
Progression-Free Survival 1 (PFS1):Time from the initiation of the first ADC (ADC1) therapy to the first occurrence of disease progression (PD) or death from any cause, whichever occurs earlier.
Measured: Until progression, assessed up to approximately 24 months
Secondary outcomes (5)
Progression-Free Survival 2 (PFS2)
Progression-Free Survival 2 (PFS2): Time from initiation of the second ADC (ADC2) therapy to the first occurrence of disease progression (PD) or death from any cause, whichever occurs earlier.
Measured: Until progression, assessed up to approximately 24 months
Objective Response Rate (ORR1, ORR2)
Objective Response Rate (ORR1, ORR2): Proportion of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
Measured: Until progression, assessed up to approximately 24 months
Disease Control Rate (DCR
Disease Control Rate (DCR): Proportion of patients with best overall response of CR, PR, or stable disease (SD) according to RECIST 1.1 criteria.
Measured: Baseline through end of study, assessed up to 24 months]
Overall Survival (OS)
Overall Survival (OS): Time from treatment initiation to death from any cause.
Measured: Until death, assessed up to approximately 24 months
Safety Endpoints
Safety Endpoints: Include adverse event profiles, incidence rates, dose reductions, treatment delays, and discontinuations due to adverse events.
Measured: Up to follow-up period, approximately 24 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start16 Jan 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368543
- Sponsor's protocol ID
- 2510331-4
- Acronym
- STORM
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequencing Sacituzumab Govitecan vs. Trastuzumab Deruxtecan in HER2-LOw/TROP2-High Metastatic Breast Cancer: A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT07368543
- Acronym / sponsor ID
- STORM / 2510331-4
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 16 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Jan 2026 (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.
Currently, no phase III RCT has directly compared SG and T-DXd sequencing strategies, and the predictive role of biomarkers remains unclear. Additionally, there is no standard scoring system for Trop-2 expression. The ASCENT trial utilized an H-score method (H-score = 3×%IHC3+ + 2×%IHC2+ + 1×%IHC1+), with scores <100, 100-200, and >200 defining low, medium, and high Trop-2 expression, respectively.This prospective study aims to: 1) Evaluate the efficacy of SG vs. T-DXd in HER2-low/Trop-2-high metastatic breast cancer, prioritizing SG for Trop-2-high patients and T-DXd for others. 2) Compare sequential treatment outcomes-T-DXd after SG failure versus SG after T-DXd failure-to inform ADC sequencing in HER2-low disease. Up to one intervening therapy is allowed before sequencing. 3) Identify biomarkers of ADC efficacy and resistance through quantitative protein analysis to optimize patient selection.
Detailed description
This investigator-initiated study aims to evaluate the efficacy of sequential treatment with sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) in patients with HER2 IHC 1+ /Trop-2-high metastatic breast cancer. It will also explore the correlation between changes in tumor-associated protein expression levels and ADC efficacy, and investigate mechanisms of ADC resistance.
The study will establish a multicenter cohort of patients treated with SG/T-DXd:
Cohort A (Triple-Negative Breast Cancer, TNBC): Includes patients with unresectable locally advanced or metastatic triple-negative breast cancer (HER2 IHC 1+) who have received ≥1 prior line of systemic therapy for metastatic disease. Prior to enrollment, all patients will undergo Trop-2 expression testing. Patients identified as Trop-2-high will be randomized 1:1 to either:SG Treatment (Trop-2 Group), orT-DXd Treatment (HER2 Group). The initially administered ADC is designated as ADC1. Upon disease progression, patients may cross over to receive the other ADC as sequential therapy (designated as ADC2). One intervening non-ADC therapy (e.g., targeted therapy, chemotherapy) is permitted prior to cross-over. Randomization will maintain a 1:1 allocation between the Trop-2 and HER2 groups.
Cohort B (HR+/HER2-ultralow or HER2 IHC 1+ Breast Cancer): Includes patients with unresectable locally advanced or metastatic HR+/HER2-ultralow or HER2 IHC 1+ breast cancer who have progressed on prior endocrine therapy. Prior to enrollment, all patients will undergo Trop-2 expression testing. Patients identified as Trop-2-high will be randomized 1:1 to either:SG Treatment (Trop-2 Group), orT-DXd Treatment (HER2 Group).
Upon progression, patients may cross over to receive the other ADC as sequential therapy. One intervening non-ADC therapy (e.g., targeted therapy, chemotherapy) is permitted prior to cross-over. Randomization will maintain a 1:1 allocation between the Trop-2 and HER2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Triple-Negative Breast Cancer) | Experimental | Drug: Sacituzumab Govitecan, Drug: Trastuzumab DeruxtecanPatients with HER2 IHC 1+ metastatic triple-negative breast cancer (TNBC); |
| Cohort B (HR+/HER2 IHC 1+ and Ultralow Metastatic Breast Cancer) | Experimental | Drug: Sacituzumab Govitecan, Drug: Trastuzumab DeruxtecanPatients with HR-positive/HER2 IHC 1+ and HER2 ultralow metastatic breast cancer (MBC) who have failed endocrine therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female, age ≥18 years.
- ECOG performance status ≤2, with an estimated life expectancy of >3 months.
- Histologically confirmed unresectable or metastatic breast cancer that is:HER2 IHC 1+ triple-negative breast cancer, or HR-positive/HER2-ultralow or HER2 IHC 1+ breast cancer.
- Planned to receive monotherapy with Sacituzumab Govitecan and Trastuzumab Deruxtecan.
- For triple-negative breast cancer: prior systemic therapy lines ≥1.
Key exclusion criteria (21 listed)
- Contraindication or known hypersensitivity to sacituzumab govitecan, trastuzumab deruxtecan, or any of their components (including topoisomerase I inhibitors).
- Prior treatment with sacituzumab govitecan, trastuzumab deruxtecan, or any other drug targeting the same molecular pathway.
- History of another primary malignancy, except for:
- Active infection or uncontrolled systemic disease, including but not limited to:
- Participation in another investigational drug trial within 4 weeks prior to the first study treatment (observational studies are permitted) or major surgery within 4 weeks prior to the first study treatment.
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 |
|---|---|---|
| Sacituzumab GovitecanRecommended Dose: 10 mg/kg administered by intravenous infusion on Days 1 and 8 of each 21-day treatment cycle. Continue treatment until disease progression or unacceptable toxicity. | Drug | Cohort A (Triple-Negative Breast Cancer), Cohort B (HR+/HER2 IHC 1+ and Ultralow Metastatic Breast Cancer) |
| Trastuzumab DeruxtecanDosage and Administration: The recommended dose is 5.4 mg/kg administered by intravenous infusion once every 3 weeks (21-day cycles). Continue treatment until disease progression or unacceptable toxicity. | Drug | Cohort A (Triple-Negative Breast Cancer), Cohort B (HR+/HER2 IHC 1+ and Ultralow Metastatic Breast Cancer) |
Primary outcome
Progression-Free Survival 1 (PFS1)
Time frame: Until progression, assessed up to approximately 24 months
Progression-Free Survival 1 (PFS1):Time from the initiation of the first ADC (ADC1) therapy to the first occurrence of disease progression (PD) or death from any cause, whichever occurs earlier.
5 secondary outcomes
Progression-Free Survival 2 (PFS2)
Time frame: Until progression, assessed up to approximately 24 months
Objective Response Rate (ORR1, ORR2)
Time frame: Until progression, assessed up to approximately 24 months
Disease Control Rate (DCR
Time frame: Baseline through end of study, assessed up to 24 months]
Overall Survival (OS)
Time frame: Until death, assessed up to approximately 24 months
Safety Endpoints
Time frame: Up to follow-up period, approximately 24 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 28 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Govitecan and Trastuzumab Deruxtecan in people with Metastatic Breast Cancer, run by Fudan University.
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 23 inclusion and 21 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: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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 Jian Zhang, MD (8664175590 ext. 85000, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival 1 (PFS1) (time frame: Until progression, assessed up to approximately 24 months). 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 28 Jan 2026.