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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer

Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer: A Multicenter Randomized Controlled Clinical Trial

Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer (NCT07401537) is a Phase 2 interventional studying Triple -Negative Breast Cancer and Breast Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Triple-negative breast cancer (TNBC), defined by the lack of ER, PR and HER2 expression, is refractory to endocrine therapy and anti-HER2 agents. Chemotherapy was once the mainstay for advanced TNBC, but its limited efficacy necessitates optimized therapeutic strategies. TNBC's high TIL infiltration and elevated PD-L1 expression confer sensitivity to immune checkpoint inhibitors (ICIs), with ICI-chemotherapy combinations initially establishing first-line standard status. Emerging clinical evidence shows that ICI-antibody-drug conjugate (ADC) combinations outperform ICI-chemotherapy regimens, yet immune-related adverse events (irAEs) remain a critical clinical challenge. Expert consensus recommends continuing ICI therapy in advanced TNBC patients achieving CR, PR or SD after ICI-based combination therapy until disease progression or intolerable toxicity. Mechanistically, once ICIs reach target receptor saturation, dose escalation or high-frequency administration fails to boost efficacy but raises toxicity risk. Thus the investigators hypothesize that an ICI maintenance strategy with fixed dose and extended intervals can preserve efficacy, reduce toxicity, improve patient compliance, enhance quality of life and alleviate economic burden for advanced TNBC patients with CR/PR/SD after ICI-chemotherapy or ICI-ADC treatment.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Triple -Negative Breast Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 416 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntary consent to participate in this study and signing of the willing to sign a consent form form. 2. The age of the signatory of the willing to sign a consent form form should be ≥18 years old and ≤70 years old. 3. Advanced (locally recurrent inoperable or metastatic) TNBC confirmed by histology or cytology, defined as ER-negative, PR-negative, and HER2-negative. 4. PD-L1 IHC detection in tumor tissue with a CPS score ≥1. 5. Have received first-line standard immunotherapy combined with chemotherapy or immunotherapy combined with ADC and completed 6 cycles, with the last dose administered no more than 28 days before randomization. 6. The therapeutic efficacy was confirmed as CR, PR or SD after 6-cycle standard treatment according to the RECIST v1.1 criteria. 7. Plan to continue receiving immunotherapy. 8. An Eastern Cooperative Oncology Group performance-status score of 0 or 1. 9. The expected survival period exceeds 12 weeks. 10. your organs (liver, kidneys, etc.) are working well enough based on blood tests:. 11. No mental or intellectual abnormalities. 12. Willing and able to comply with the trial protocol during the trial period. 13. Female subjects of childbearing potential must agree to use highly effective contraceptive measures starting at least 7 days before the first dose and continuing until 24 weeks after the last dose. The serum pregnancy test result must be negative within 7 days prior to the first dose. Who Should NOT Join This Trial: 1. Untreated active brain metastases or meningeal metastases. 2. Concomitant other malignant tumors with progression within the recent 5 years or requiring active treatment (excluding adequately treated and controlled carcinoma in situ and non-melanoma skin cancer). 3. Concomitant severe non-malignant diseases that would affect the patient's compliance or put the patient at risk. 4. Concomitant active infection. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Voluntary consent to participate in this study and signing of the informed consent form. 2. The age of the signatory of the informed consent form should be ≥18 years old and ≤70 years old. 3. Advanced (locally recurrent inoperable or metastatic) TNBC confirmed by histology or cytology, defined as ER-negative, PR-negative, and HER2-negative. 4. PD-L1 IHC detection in tumor tissue with a CPS score ≥1. 5. Have received first-line standard immunotherapy combined with chemotherapy or immunotherapy combined with ADC and completed 6 cycles, with the last dose administered no more than 28 days before randomization. 6. The therapeutic efficacy was confirmed as CR, PR or SD after 6-cycle standard treatment according to the RECIST v1.1 criteria. 7. Plan to continue receiving immunotherapy. 8. An Eastern Cooperative Oncology Group performance-status score of 0 or 1. 9. The expected survival period exceeds 12 weeks. 10. Adequate organ function:. 11. No mental or intellectual abnormalities. 12. Willing and able to comply with the trial protocol during the trial period. 13. Female subjects of childbearing potential must agree to use highly effective contraceptive measures starting at least 7 days before the first dose and continuing until 24 weeks after the last dose. The serum pregnancy test result must be negative within 7 days prior to the first dose. Exclusion Criteria: 1. Untreated active brain metastases or meningeal metastases. 2. Concomitant other malignant tumors with progression within the recent 5 years or requiring active treatment (excluding adequately treated and controlled carcinoma in situ and non-melanoma skin cancer). 3. Concomitant severe non-malignant diseases that would affect the patient's compliance or put the patient at risk. 4. Concomitant active infection. 5. Receiving other anti-tumor therapies or participating in other interventional clinical trials. 6. Inflammatory breast cancer. 7. Dementia, intellectual disability, or any mental disorders that hinder the understanding of the informed consent form. 8. History of allergic reactions to any components of the study drugs or existing contraindications to their use. 9. Presence of any active autoimmune diseases or history of autoimmune diseases. 10. Presence of poorly controlled clinical cardiac symptoms or diseases, such as:1) Heart failure of NYHA class II or above;2) Unstable angina pectoris;3) Myocardial infarction occurring within 1 year;4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 11. Presence of grade ≥3 toxicities related to prior treatments that restrict the continuation of maintenance therapy. 12. History of immunodeficiency, including HIV positivity, active HBV/HCV infection, other acquired or congenital immunodeficiency diseases, and history of organ or allogeneic stem cell transplantation. 13. Vaccination with live vaccines within 4 weeks prior to the administration of study drugs or planned vaccination during the study period. 14. Prior administration of irinotecan, topotecan, or any other topoisomerase I inhibitors (including investigational topoisomerase I inhibitors), or known history of allergies to the above-mentioned drugs. 15. Use of systemic glucocorticoids at a dose exceeding 10 mg/day of prednisone equivalent within 14 days prior to the administration of study drugs, or planned long-term use of the above dose during the study period (topical, inhaled, or short-term (≤7 days) pulse doses ≤10 mg/day of prednisone equivalent, or physiological dose replacement therapy are allowed for inclusion). 16. Need for use of any immunosuppressants within 14 days prior to the administration of study drugs or planned use during the study period. 17. Pregnant or lactating women, or women of childbearing potential who refuse to accept contraceptive measures. 18. Patients who are difficult or impossible to follow up. 19. Subjects judged by the investigator to have conditions that may affect compliance or other circumstances making them unsuitable for inclusion.

Treatments Being Tested

DRUG

Extended-Dose Interval Immunotherapy

During the maintenance therapy phase, the dose of PD-1 inhibitors is maintained at the same level as in the standard treatment phase, with the dosing interval extended to every 6 weeks (q6w).

DRUG

Standard-Dose Interval Immunotherapy

During the maintenance therapy phase, the dosage and dosing interval of PD-1 inhibitors are consistent with those in the standard therapy phase, administered every 3 weeks (q3w).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Breast Tumor Center, Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07401537), the sponsor (Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07401537 clinical trial studying?

Triple-negative breast cancer (TNBC), defined by the lack of ER, PR and HER2 expression, is refractory to endocrine therapy and anti-HER2 agents. Chemotherapy was once the mainstay for advanced TNBC, but its limited efficacy necessitates optimized therapeutic strategies. TNBC's high TIL infiltration and elevated PD-L1 expression confer sensitivity to immune checkpoint inhibitors (ICIs), with ICI-chemotherapy combinations initially establishing first-line standard status. Emerging clinical evidence shows that ICI-antibody-drug conjugate (ADC) combinations outperform ICI-chemotherapy regimens, y… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07401537?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07401537?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07401537. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07401537. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.