Adjuvant Drug TherapyPhase 3STARTERNCT07628504

Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA Mutations

A Phase 3 study testing Sacituzumab Tirumotecan (sac-TMT) and Capecitabine in people with Adjuvant Drug Therapy, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

The goal of this clinical trial is to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT) sequential capecitabine versus single-agent capecitabine as adjuvant intensified therapy in patients with high-risk early-stage triple-negative breast cancer (TNBC) without BRCA mutations. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Adjuvant Drug Therapy
What is being tested?: Sacituzumab Tirumotecan (sac-TMT) and Capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 420 participants
Where: 1 siteChina
Study dates: 18 May 2026to 30 Mar 2035
Phase: Phase 3
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female aged ≥ 18 years old.
Diagnosis of operable primary invasive breast cancer.
Negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER2), defined as follows: ER-negative is defined as <10 % positive tumor cells by immunohistochemistry (IHC); PR-negative is defined as <10 % positive tumor cells by IHC; HER2-negative is defined as IHC score of 0 or 1+, or IHC score of 2+ with negative (non-amplified) results confirmed by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH).
Non-mutated for BRCA1/2 genes.
Patients must satisfy any one of the following conditions:
Baseline clinical lymph node-positive (cLN+) or pathological lymph node-positive (pN+) status with non-pathological complete response (non-pCR), who have completed adequate neoadjuvant therapy (at least 6 cycles of chemotherapy containing anthracycline and/or taxane, with or without PD-1 inhibitor immunotherapy).

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Pathological lymph node-positive (pN+) status without prior neoadjuvant therapy, who have undergone adequate surgery, adjuvant chemotherapy (at least 6 cycles of taxane- and/or anthracycline-containing regimen with or without carboplatin), and adjuvant radiotherapy (if applicable).
No evidence of distant metastasis shown by imaging examinations performed within 3 months prior to randomization.
Adequate organ and bone marrow function.
Acute toxicities from any prior therapy have recovered to baseline levels or resolved to Grade ≤ 1 per NCI CTCAE Version 5.0 (excluding adverse events deemed non-safety risks at the investigator's discretion).
Post-menopausal status or documented non-childbearing potential. For women of childbearing potential, urine pregnancy tests must be negative at post-surgery screening and baseline visits. All participants and their male partners of childbearing potential must use effective medical contraception from the date of informed consent signature until 6 months after the last dose of study treatment.
Voluntarily participate in the study, provide written informed consent, and be able to comply with protocol-specified visits and procedures.

Who cannot join

Patients with Stage T4 disease, including those with inflammatory breast cancer;
Patients with Stage N3 disease;
Patients with positive supraclavicular or internal mammary lymph nodes;
Previous history of breast cancer;
Significant cardiovascular diseases such as baseline left ventricular ejection fraction (LVEF) < 50% assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan at screening, or New York Heart Association (NYHA) Class III or IV cardiomyopathy;
Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors;

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History of other malignant neoplasms within the past 5 years, excluding cured carcinoma in situ of the cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma;
Known hypersensitivity to study drugs and their components, history of immunodeficiency, or history of organ transplantation;
History of non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy, current ILD or non-infectious pneumonia, or suspected ILD/non-infectious pneumonia that cannot be ruled out by imaging at screening; clinically significant severe pulmonary impairment secondary to concomitant pulmonary diseases, including but not limited to any underlying pulmonary disorders (e.g., pulmonary embolism within 3 months prior to first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) or any autoimmune, connective tissue, or inflammatory diseases potentially involving the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), or prior pneumonectomy;
Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disorders that hinder delayed corneal healing;
Active autoimmune diseases requiring systemic therapy within the past 2 years (hormone replacement therapy is not considered systemic therapy, e.g., type 1 diabetes mellitus, hypothyroidism managed with thyroid hormone replacement only, adrenal or pituitary insufficiency managed with physiological-dose glucocorticoid replacement only);
Active infections requiring systemic therapy within 2 weeks prior to the first dose;
Patients with malabsorption syndromes affecting glucuronosyltransferase (Gl) function, history of gastric or small bowel resection, or inability to swallow capecitabine tablets;
Concomitant severe diseases that jeopardize patient safety or interfere with study completion as judged by the investigator, including but not limited to uncontrolled hypertension, severe diabetes mellitus, and active infections;
Any other conditions rendering the patient ineligible for study participation in the investigator's opinion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Fudan University Shanghai Cancer Center, Shanghai, Shanghai 200032
Shanghai, Shanghai Municipality, 200032
Keda Yu Professor, +86-021-64175590, yukeda@fudan.edu.cn

Other trials in China

About this study

Official title: Sacituzumab Tirumotecan (Sac-TMT) Sequential Capecitabine Versus Capecitabine as Adjuvant Regimen for Triple-Negative Breast Cancer With Early-Stage, High-Risk, Non-BRCA Mutated Status: A Phase III, Randomized, Controlled, Open-Label, Multicenter Clinical Trial

The main questions it aims to answer are:

Does sacituzumab tirumotecan (sac-TMT) sequential capecitabine improve survival outcomes compared with capecitabine monotherapy in this patient population?
What is the safety profile of sacituzumab tirumotecan (sac-TMT)-containing adjuvant therapy versus capecitabine monotherapy? Researchers will compare the sacituzumab tirumotecan (sac-TMT)-sequential-capecitabine experimental arm with the capecitabine-alone control arm to see if the experimental regimen provides superior adjuvant anti-tumor efficacy with acceptable safety.

Participants will be randomized in a 1:1 to Receive assigned study treatment as follows:

Experimental arm: Sacituzumab tirumotecan (sac-TMT) 4 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles, followed by sequential capecitabine at stratified doses; patients with prior PD-1/L1 inhibitor exposure will continue PD-1/L1 inhibitor therapy for up to 1 year Control arm: Capecitabine monotherapy at stratified doses; patients with prior PD-1/L1 inhibitor exposure will continue PD-1/L1 inhibitor therapy for up to 1 year

Conditions: Adjuvant Drug Therapy
Being tested: Sacituzumab Tirumotecan (sac-TMT), Capecitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sacituzumab Tirumotecan (sac-TMT)Drug
Sacituzumab Tirumotecan (sac-TMT) is administered intravenously at a dose of 4 mg/kg on Day 1 of each 3-week cycle for a total of 8 cycles.
CapecitabineDrug
Capecitabine is administered orally with stratified doses based on prior neoadjuvant therapy status: for patients who received neoadjuvant therapy, capecitabine is given at 1000-1250 mg/m² twice daily on a 2-week-on-1-week-off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given at 650 mg/m² twice daily for 1 year.

Study groups in NCT07628504
Study group	Role	What they receive
Arm A (Sac-TMT)	Experimental	Sacituzumab Tirumotecan (sac-TMT) is administered intravenously at a dose of 4 mg/kg on Day 1 of each 3-week cycle for a total of 8 cycles. Following completion of the 8 cycles, sequential capecitabine therapy may be administered at the investigator's discretion, with stratified dosing regimens as follows: for patients who received neoadjuvant therapy, capecitabine is given orally at 1000-1250 mg/m² twice daily, on a 2-week on/1-week off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given orally at 650 mg/m² twice daily for 1 year. Patients who received PD-1/L1 inhibitor therapy during the neoadjuvant phase shall continue PD-1/L1 inhibitor treatment for up to 1 year in total. Receives: Drug: Sacituzumab Tirumotecan (sac-TMT)
Arm B (capecitabine)	Active comparator	Capecitabine is administered orally with stratified doses based on prior neoadjuvant therapy status: for patients who received neoadjuvant therapy, capecitabine is given at 1000-1250 mg/m² twice daily on a 2-week-on-1-week-off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given at 650 mg/m² twice daily for 1 year. Patients who received PD-1/L1 inhibitor therapy during the neoadjuvant phase shall continue PD-1/L1 inhibitor treatment until completion of 1-year total duration. Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease-Free Survival (DFS)
Disease-Free Survival (DFS), defined as the time from randomization to disease recurrence or death from any cause, whichever occurs first.
Measured: 3-year DFS

Secondary outcomes (3)

Distant Disease-Free Survival (DDFS)
Measured: from the first dose administration to the first occurrence of distant metastasis or death due to breast cancer, whichever occurs first.up to 5 years
Overall survival
Measured: from the first dose administration to death from any cause of the participant.up to 5 years
Adverse events (AEs)
Measured: 90 days after the last administration of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202630 Mar 2035

First posted5 Jun 2026
Study start18 May 2026 (estimated)
Primary completion30 Mar 2030 (estimated)
Study completion30 Mar 2035 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Adjuvant Drug TherapyStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 420 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07628504
Sponsor's protocol ID: SCHBCC-N0113
Acronym: STARTER
Status last verified: Jun 2026
First submitted: 25 May 2026
Last updated: 5 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sacituzumab Tirumotecan (Sac-TMT) Sequential Capecitabine Versus Capecitabine as Adjuvant Regimen for Triple-Negative Breast Cancer With Early-Stage, High-Risk, Non-BRCA Mutated Status: A Phase III, Randomized, Controlled, Open-Label, Multicenter Clinical Trial
ClinicalTrials.gov ID: NCT07628504
Acronym / sponsor ID: STARTER / SCHBCC-N0113
Conditions: Adjuvant Drug Therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 420 participants (estimated)
Lead sponsor: Fudan UniversityUniversity, hospital or other
Study start: 18 May 2026 (estimated)
Primary completion: 30 Mar 2030 (estimated)
Study completion: 30 Mar 2035 (estimated)
First posted: 5 Jun 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.

The main questions it aims to answer are:

Does sacituzumab tirumotecan (sac-TMT) sequential capecitabine improve survival outcomes compared with capecitabine monotherapy in this patient population?
What is the safety profile of sacituzumab tirumotecan (sac-TMT)-containing adjuvant therapy versus capecitabine monotherapy? Researchers will compare the sacituzumab tirumotecan (sac-TMT)-sequential-capecitabine experimental arm with the capecitabine-alone control arm to see if the experimental regimen provides superior adjuvant anti-tumor efficacy with acceptable safety.

Participants will be randomized in a 1:1 to Receive assigned study treatment as follows:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A (Sac-TMT)	Experimental	Drug: Sacituzumab Tirumotecan (sac-TMT)Sacituzumab Tirumotecan (sac-TMT) is administered intravenously at a dose of 4 mg/kg on Day 1 of each 3-week cycle for a total of 8 cycles. Following completion of the 8 cycles, sequential capecitabine therapy may be administered at the investigator's discretion, with stratified dosing regimens as follows: for patients who received neoadjuvant therapy, capecitabine is given orally at 1000-1250 mg/m² twice daily, on a 2-week on/1-week off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given orally at 650 mg/m² twice daily for 1 year. Patients who received PD-1/L1 inhibitor therapy during the neoadjuvant phase shall continue PD-1/L1 inhibitor treatment for up to 1 year in total.
Arm B (capecitabine)	Active comparator	Drug: CapecitabineCapecitabine is administered orally with stratified doses based on prior neoadjuvant therapy status: for patients who received neoadjuvant therapy, capecitabine is given at 1000-1250 mg/m² twice daily on a 2-week-on-1-week-off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given at 650 mg/m² twice daily for 1 year. Patients who received PD-1/L1 inhibitor therapy during the neoadjuvant phase shall continue PD-1/L1 inhibitor treatment until completion of 1-year total duration.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Female aged ≥ 18 years old.
Diagnosis of operable primary invasive breast cancer.
Negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER2), defined as follows: ER-negative is defined as <10 % positive tumor cells by immunohistochemistry (IHC); PR-negative is defined as <10 % positive tumor cells by IHC; HER2-negative is defined as IHC score of 0 or 1+, or IHC score of 2+ with negative (non-amplified) results confirmed by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH).
Non-mutated for BRCA1/2 genes.
Patients must satisfy any one of the following conditions:

Key exclusion criteria (15 listed)

Patients with Stage T4 disease, including those with inflammatory breast cancer;
Patients with Stage N3 disease;
Patients with positive supraclavicular or internal mammary lymph nodes;
Previous history of breast cancer;
Significant cardiovascular diseases such as baseline left ventricular ejection fraction (LVEF) < 50% assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan at screening, or New York Heart Association (NYHA) Class III or IV cardiomyopathy;

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 Tirumotecan (sac-TMT)Sacituzumab Tirumotecan (sac-TMT) is administered intravenously at a dose of 4 mg/kg on Day 1 of each 3-week cycle for a total of 8 cycles.	Drug	Arm A (Sac-TMT)
CapecitabineCapecitabine is administered orally with stratified doses based on prior neoadjuvant therapy status: for patients who received neoadjuvant therapy, capecitabine is given at 1000-1250 mg/m² twice daily on a 2-week-on-1-week-off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given at 650 mg/m² twice daily for 1 year.	Drug	Arm B (capecitabine)

Primary outcome

Disease-Free Survival (DFS)
Time frame: 3-year DFS
Disease-Free Survival (DFS), defined as the time from randomization to disease recurrence or death from any cause, whichever occurs first.

3 secondary outcomes

Distant Disease-Free Survival (DDFS)
Time frame: from the first dose administration to the first occurrence of distant metastasis or death due to breast cancer, whichever occurs first.up to 5 years
Overall survival
Time frame: from the first dose administration to death from any cause of the participant.up to 5 years
Adverse events (AEs)
Time frame: 90 days after the last administration of study treatment

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 Jun 2026.
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.

Fudan University Shanghai Cancer Center, Shanghai, Shanghai 200032

Shanghai, China

+86-021-64175590

yukeda@fudan.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab Tirumotecan (sac-TMT) and Capecitabine in people with Adjuvant Drug Therapy, run by Fudan University at 1 site in China.

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 12 inclusion and 15 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 5 Jun 2026. 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 China. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) (time frame: 3-year DFS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07628504.

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 Jun 2026.