Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07401537

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

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-02-10

416

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary consent to participate and signing informed consent form.
  • Age between 18 and 70 years.
  • Advanced (locally recurrent inoperable or metastatic) triple-negative breast cancer confirmed by histology or cytology, defined as ER-negative, PR-negative, and HER2-negative.
  • PD-L1 immunohistochemistry detection in tumor tissue with a combined positive score (CPS) of 1 or higher.
  • Completed 6 cycles of first-line standard immunotherapy combined with chemotherapy or immunotherapy combined with antibody-drug conjugates, with the last dose given no more than 28 days before randomization.
  • Therapeutic efficacy confirmed as complete response (CR), partial response (PR), or stable disease (SD) after 6-cycle standard treatment according to RECIST v1.1 criteria.
  • Plan to continue receiving immunotherapy.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • Expected survival period exceeds 12 weeks.
  • Adequate organ function.
  • No mental or intellectual abnormalities.
  • Willing and able to comply with trial protocol during the study period.
  • Female subjects of childbearing potential must agree to use highly effective contraception starting at least 7 days before first dose and continuing until 24 weeks after last dose, with a negative serum pregnancy test within 7 days prior to first dose.
Not Eligible

You will not qualify if you...

  • Untreated active brain or meningeal metastases.
  • Other malignant tumors progressing within the last 5 years or requiring active treatment (excluding adequately treated carcinoma in situ and non-melanoma skin cancer).
  • Severe non-malignant diseases affecting compliance or increasing risk.
  • Active infections.
  • Receiving other anti-tumor therapies or participating in other interventional clinical trials.
  • Inflammatory breast cancer.
  • Dementia, intellectual disability, or mental disorders preventing informed consent.
  • History of allergic reactions to study drug components or contraindications to their use.
  • Active or history of autoimmune diseases.
  • Poorly controlled cardiac conditions including heart failure NYHA class II or above, unstable angina, recent myocardial infarction, or significant arrhythmias.
  • Grade 3 or higher toxicities from prior treatments limiting maintenance therapy.
  • History of immunodeficiency including HIV, active hepatitis B or C, other immunodeficiencies, or prior organ/stem cell transplant.
  • Vaccination with live vaccines within 4 weeks before study drug administration or planned during study.
  • Prior use or allergy to irinotecan, topotecan, or other topoisomerase I inhibitors.
  • Use of systemic glucocorticoids over 10 mg/day prednisone equivalent within 14 days before study drug or planned long-term use above this dose.
  • Need for immunosuppressants within 14 days before study drug or planned use during study.
  • Pregnant or breastfeeding women or women refusing contraceptive measures.
  • Difficulty or inability to follow up.
  • Any condition judged by investigator as unsuitable for participation.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Breast Tumor Center, Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

J

Jieqiong Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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