Triple -Negative Breast CancerPhase 2NCT07007780
Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC
A Phase 2 study testing Sacituzumab Tirumotecan in people with Triple -Negative Breast Cancer, run by Xijing Hospital.
Trial summary
To explore the application of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC, a multicenter, Phase II clinical study of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC is proposed. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple -Negative Breast Cancer
- What is being tested?
- Sacituzumab Tirumotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 30 Aug 2027
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Female subjects aged ≥18 years and ≤70 years at the time of signing the informed consent form.
- ECOG Performance Status: 0-1.
- Life Expectancy: Estimated survival of not less than 3 months.
- Measurable Disease: Presence of at least one measurable lesion according to RECIST 1.1 criteria.
- Histopathological Diagnosis: Invasive breast cancer, staged as T1c N1-2 or T2-4 N0-2 according to the AJCC classification.
- TNBC Confirmation: Confirmed as TNBC based on histology and/or cytology, and meeting the following criteria:
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- HER2-negative: IHC score of 0 or 1+; if IHC is 2+, confirmed negative by fluorescence in situ hybridization (FISH).
- ER and PR-negative: IHC showing <1% of cells expressing hormone receptors; in case of multiple pathological results, the molecular subtype of the last biopsy is considered the final subtype.
- No Prior Systemic Anti-cancer Treatment: No prior systemic anti-cancer treatment.
- Availability of Tissue Samples: Availability of tissue samples for biomarker testing.
- Adequate Organ and Marrow Function: (No transfusions, recombinant human thrombopoietin, or colony-stimulating factor within 2 weeks before the first dose), defined as follows:
- Hematology: Absolute neutrophil count (NEUT#) ≥1.5×10^9/L; platelets (PLT) ≥100×10^9/L; hemoglobin ≥9 g/dL.
- Liver Function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); total bilirubin (TBIL) ≤1.5×ULN.
- Renal Function: Creatinine clearance (Ccr) ≥60 ml/min (Cockcroft-Gault formula is provided in the appendix).
- Coagulation Function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤1.5×ULN.
- Cardiac Function: Left ventricular ejection fraction (LVEF) ≥50% as shown by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
- Contraception: For female subjects of childbearing potential and male subjects with partners of childbearing potential, agreement to use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose.
- Voluntary Participation: Willingness to participate in the study, signing the informed consent form, having good compliance, and willingness to cooperate with follow-up
Who cannot join
- Patients with metastatic breast cancer (Stage IV).
- Baseline left ventricular ejection fraction (LVEF) <50% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at screening, or other significant cardiovascular diseases, or a history of Class III or IV cardiomyopathy described by the New York Heart Association on the same side as the invasive breast cancer.
- Chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiotherapy for the currently diagnosed breast cancer before enrollment.
- Previous treatment targeting TROP2 or treatment with a topoisomerase I inhibitor.
- A history of other malignancies within the past 5 years, excluding cured cervical in situ carcinoma, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
- Known allergy to the study drug or its components.
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- A history of immunodeficiency or organ transplantation.
- Documented severe dry eye syndrome, severe meibomian gland disease, and/or blepharitis, or a history of corneal diseases that may impede delayed corneal healing.
- A history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current ILD or non-infectious pneumonia, or suspicious ILD or non-infectious pneumonia at screening that cannot be excluded by imaging studies; clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within 3 months before dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or a history of pneumonectomy.
- Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as Type I diabetes, hypothyroidism requiring only thyroid hormone replacement, adrenal or pituitary insufficiency requiring only physiologic doses of glucocorticoid replacement).
- Active infection requiring systemic treatment within 2 weeks before the first dose.
- Any comorbidities that, in the investigator's judgment, pose a serious risk to patient safety or may affect the patient's ability to complete the study, including but not limited to uncontrolled hypertension, severe diabetes, active infections, etc.
- Any condition or other circumstances that the investigator believes may interfere with the evaluation of the study drug, the safety of the subject, or the interpretation of the study results, or any other condition that the investigator deems unsuitable for participation in this study.
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: A Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC
To explore the application of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC, a multicenter, Phase II clinical study of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Sacituzumab Tirumotecan and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.
Read the detailed description
This study is a multicenter, Phase II clinical trial, planning to enroll 35 eligible early-stage TNBC patients who meet the inclusion and exclusion criteria. Patients will receive neoadjuvant treatment with Sacituzumab Tirumotecan monotherapy before surgery at a dose of 5mg/kg, with a dosing schedule of once every 2 weeks for a total of 12 weeks. Imaging assessments will be conducted every 4 weeks during the neoadjuvant treatment phase. After the neoadjuvant treatment is completed, surgery will be performed within 4 weeks of the last study drug administration. Whether to receive adjuvant treatment after surgery will be determined by the investigator. The primary endpoint of the study is the pathological complete response (pCR) rate. Secondary endpoints include objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety.
- Conditions
- Triple -Negative Breast Cancer
- Being tested
- Sacituzumab Tirumotecan
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab TirumotecanDrug
Sacituzumab Tirumotecan monotherapy before surgery at a dose of 5mg/kg, with a dosing schedule of once every 2 weeks for a total of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Neadjuvant Sacituzumab Tirumotecan | Experimental | Neadjuvant Sacituzumab Tirumotecan Receives: Drug: Sacituzumab Tirumotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
Measured: At the end of Cycle 1 (each cycle is 14 days)
Secondary outcomes (3)
adverse effects
Serious adverse effect occur within neoadjuvant chemotherapy
Measured: through each neoadjuvant chemotherapy Cycle (each cycle is 14 days)]
Objective Reaponse Rate(ORR)
Measured: At the end of every cycle (each cycle is 14 days)
Event-free survival (EFS)
Defined as the time from treatment initiation to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, or death from any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start20 Aug 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple -Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007780
- Sponsor's protocol ID
- KY20252174-F-1
- Status last verified
- Jul 2025
- First submitted
- 26 May 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC
- ClinicalTrials.gov ID
- NCT07007780
- Acronym / sponsor ID
- KY20252174-F-1
- Conditions
- Triple -Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 6 Jun 2025 (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.
To explore the application of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC, a multicenter, Phase II clinical study of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Sacituzumab Tirumotecan and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.
Detailed description
This study is a multicenter, Phase II clinical trial, planning to enroll 35 eligible early-stage TNBC patients who meet the inclusion and exclusion criteria. Patients will receive neoadjuvant treatment with Sacituzumab Tirumotecan monotherapy before surgery at a dose of 5mg/kg, with a dosing schedule of once every 2 weeks for a total of 12 weeks. Imaging assessments will be conducted every 4 weeks during the neoadjuvant treatment phase. After the neoadjuvant treatment is completed, surgery will be performed within 4 weeks of the last study drug administration. Whether to receive adjuvant treatment after surgery will be determined by the investigator. The primary endpoint of the study is the pathological complete response (pCR) rate. Secondary endpoints include objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neadjuvant Sacituzumab Tirumotecan | Experimental | Drug: Sacituzumab TirumotecanNeadjuvant Sacituzumab Tirumotecan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age: Female subjects aged ≥18 years and ≤70 years at the time of signing the informed consent form.
- ECOG Performance Status: 0-1.
- Life Expectancy: Estimated survival of not less than 3 months.
- Measurable Disease: Presence of at least one measurable lesion according to RECIST 1.1 criteria.
- Histopathological Diagnosis: Invasive breast cancer, staged as T1c N1-2 or T2-4 N0-2 according to the AJCC classification.
Key exclusion criteria (13 listed)
- Patients with metastatic breast cancer (Stage IV).
- Baseline left ventricular ejection fraction (LVEF) <50% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at screening, or other significant cardiovascular diseases, or a history of Class III or IV cardiomyopathy described by the New York Heart Association on the same side as the invasive breast cancer.
- Chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiotherapy for the currently diagnosed breast cancer before enrollment.
- Previous treatment targeting TROP2 or treatment with a topoisomerase I inhibitor.
- A history of other malignancies within the past 5 years, excluding cured cervical in situ carcinoma, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
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 TirumotecanSacituzumab Tirumotecan monotherapy before surgery at a dose of 5mg/kg, with a dosing schedule of once every 2 weeks for a total of 12 weeks | Drug | Neadjuvant Sacituzumab Tirumotecan |
Primary outcome
Pathological complete response rate (pCR)
Time frame: At the end of Cycle 1 (each cycle is 14 days)
3 secondary outcomes
adverse effects
Time frame: through each neoadjuvant chemotherapy Cycle (each cycle is 14 days)]
Objective Reaponse Rate(ORR)
Time frame: At the end of every cycle (each cycle is 14 days)
Event-free survival (EFS)
Time frame: Up to 2 years
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 29 Jul 2025.
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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 Tirumotecan in people with Triple -Negative Breast Cancer, run by Xijing Hospital.
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 18 inclusion and 13 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 29 Jul 2025. 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 NanLin Li (+86 13709113279, nanlin-74@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: At the end of Cycle 1 (each cycle is 14 days)). 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 29 Jul 2025.