Triple -Negative Breast CancerPhase 2NCT07401537
Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer
A Phase 2 study testing Extended-Dose Interval Immunotherapy and Standard-Dose Interval Immunotherapy in people with Triple -Negative Breast Cancer and Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Triple -Negative Breast Cancer, Breast Cancer
- What is being tested?
- Extended-Dose Interval Immunotherapy and Standard-Dose Interval Immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 31 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary consent to participate in this study and signing of the informed consent form.
- The age of the signatory of the informed consent form should be ≥18 years old and ≤70 years old.
- Advanced (locally recurrent inoperable or metastatic) TNBC confirmed by histology or cytology, defined as ER-negative, PR-negative, and HER2-negative.
- PD-L1 IHC detection in tumor tissue with a CPS score ≥1.
- 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.
- The therapeutic efficacy was confirmed as CR, PR or SD after 6-cycle standard treatment according to the RECIST v1.1 criteria.
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- Plan to continue receiving immunotherapy.
- An Eastern Cooperative Oncology Group performance-status score of 0 or 1.
- The expected survival period exceeds 12 weeks.
- Adequate organ function:.
- No mental or intellectual abnormalities.
- Willing and able to comply with the trial protocol during the trial period.
- 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 cannot join
- Untreated active brain metastases or meningeal metastases.
- 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).
- Concomitant severe non-malignant diseases that would affect the patient's compliance or put the patient at risk.
- Concomitant active infection.
- Receiving other anti-tumor therapies or participating in other interventional clinical trials.
- Inflammatory breast cancer.
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- Dementia, intellectual disability, or any mental disorders that hinder the understanding of the informed consent form.
- History of allergic reactions to any components of the study drugs or existing contraindications to their use.
- Presence of any active autoimmune diseases or history of autoimmune diseases.
- 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.
- Presence of grade ≥3 toxicities related to prior treatments that restrict the continuation of maintenance therapy.
- 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.
- Vaccination with live vaccines within 4 weeks prior to the administration of study drugs or planned vaccination during the study period.
- 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.
- 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).
- Need for use of any immunosuppressants within 14 days prior to the administration of study drugs or planned use during the study period.
- Pregnant or lactating women, or women of childbearing potential who refuse to accept contraceptive measures.
- Patients who are difficult or impossible to follow up.
- Subjects judged by the investigator to have conditions that may affect compliance or other circumstances making them unsuitable for inclusion.
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, 1 recruiting
- Recruiting
Breast Tumor Center, Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Jieqiong Liu, 086-13922272706, liujieqiong01@163.com
About this study
Official title: 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
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
- Triple -Negative Breast Cancer, Breast Cancer
- Being tested
- Extended-Dose Interval Immunotherapy, Standard-Dose Interval Immunotherapy
- Keywords
- Immune-checkpoint inhibitors, Dose Interval
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-Dose Interval ImmunotherapyDrug
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).
Standard-Dose Interval ImmunotherapyDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Extended-Dose Interval | Experimental | During the maintenance therapy phase, the dose of PD-1 inhibitors is consistent with that of the standard therapy phase, administered every 6 weeks (q6w); the dose of chemotherapy or TROP2-ADC drugs is consistent with that of the standard therapy phase, administered every 3 weeks (q3w). Receives: Drug: Extended-Dose Interval Immunotherapy |
| Standard-Dose Interval | Active comparator | During the maintenance therapy phase, the dosages of PD-1 inhibitors, chemotherapy, or TROP2-ADC drugs are maintained at the same levels as those in the standard treatment phase, administered every 3 weeks (q3w). Receives: Drug: Standard-Dose Interval Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mPFS
Refers to the time from randomization date to the first observation of disease progression (based on RECIST v1.1 criteria) or death from any cause, whichever occurs first.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Secondary outcomes (10)
mOS
The time from randomization date to any cause of death date.
Measured: From date of randomization until the date of death from any cause, assessed up to 3 years.
DoR
Refers to the time from the date of achieving CR or PR to the first disease progression (PD) or death from any cause, whichever occurs first.
Measured: From date of achieving CR or PR until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
DDC
Refers to the time from the date of achieving CR, PR, or SD to the first evaluation as PD or death from any cause, whichever occurs first.
Measured: From date of achieving CR, PR, or SD until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Assessment of quality of life via the EORTC QLQ-C30 questionnaire.
Patient reported outcomes via the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30). It contains 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), a global health and quality of life scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact). The global health and quality of life scale uses a 7-point scale scoring with anchors (1=very poor and 7=excellent); the other items are scored on a 4 point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much).
Measured: 3 years.
Assessment of quality of life via the EORTC QLQ-BR42 questionnaire.
Patient reported outcomes via the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 42 (EORTC QLQ-BR42). It consists of 42 items that formed ten scales (Breast Symptoms, Body Image, Sexual Functioning, Arm Symptoms, Systemic Chemotherapy Side Effects, Hand/Feet Symptoms/Neuropathy, Skeletal Symptoms Scale, Endocrine Symptoms, Breast Satisfaction, Vaginal Symptoms) and 3 single items (Weight Gain, Sexual Enjoyment, and Future Perspective). The items are scored on a 4 point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much).
Measured: 3 years.
Assessment of quality of life via the EQ-5D-5L questionnaire.
Patient reported outcomes via the 5-level EuroQol-5D (EQ-5D-5L questionnaire). It consists of 5 health state dimensions: mobility, self-care, usual activities, pain, and anxiety. Each dimension is rated on a five-point scale from 1 (extreme problem) to 5 (no problem). It also includes a vertical visual analog scale with a graded scoring system: 0 represents the worst imaginable health status, while 100 represents the best.
Measured: 3 years.
Assessment of quality of life via the HADS questionnaire.
Patient reported outcomes via the Hospital anxiety and depression scale (HADS). It is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Each item is rated on a 4-point Likert scale (0 = "not at all", 1 = "a little", 2 = "quite a bit", and 3 = "very much"), with higher scores indicating more distress.
Measured: 3 years.
Assessment of quality of life via the FCRI questionnaire.
Patient reported outcomes via the Fear of Cancer Recurrence Inventory (FCRI). The scale is assessed using a 5-point Likert scale, where level 0 indicates "never or not at all" and level 4 indicates "a lot or always".
Measured: 3 years.
AE
Incidence and severity of adverse events
Measured: 3 years.
Cost-Utility Analysis
Measured by incremental cost-effectiveness ratio (ICER), expressed as the cost per quality-adjusted life year (QALY) gained.
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start31 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Outcomes assessor
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieqiong Liu, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401537
- Sponsor's protocol ID
- SYSKY-2025-962-02
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2026
- Last updated
- 10 Feb 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07401537
- Acronym / sponsor ID
- SYSKY-2025-962-02
- Conditions
- Triple -Negative Breast Cancer, Breast Cancer
- Keywords
- Immune-checkpoint inhibitors, Dose Interval
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended-Dose Interval | Experimental | Drug: Extended-Dose Interval ImmunotherapyDuring the maintenance therapy phase, the dose of PD-1 inhibitors is consistent with that of the standard therapy phase, administered every 6 weeks (q6w); the dose of chemotherapy or TROP2-ADC drugs is consistent with that of the standard therapy phase, administered every 3 weeks (q3w). |
| Standard-Dose Interval | Active comparator | Drug: Standard-Dose Interval ImmunotherapyDuring the maintenance therapy phase, the dosages of PD-1 inhibitors, chemotherapy, or TROP2-ADC drugs are maintained at the same levels as those in the standard treatment phase, administered every 3 weeks (q3w). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntary consent to participate in this study and signing of the informed consent form.
- The age of the signatory of the informed consent form should be ≥18 years old and ≤70 years old.
- Advanced (locally recurrent inoperable or metastatic) TNBC confirmed by histology or cytology, defined as ER-negative, PR-negative, and HER2-negative.
- PD-L1 IHC detection in tumor tissue with a CPS score ≥1.
- 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.
Key exclusion criteria (19 listed)
- Untreated active brain metastases or meningeal metastases.
- 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).
- Concomitant severe non-malignant diseases that would affect the patient's compliance or put the patient at risk.
- Concomitant active infection.
- Receiving other anti-tumor therapies or participating in other interventional clinical trials.
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 |
|---|---|---|
| Extended-Dose Interval ImmunotherapyDuring 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 | Extended-Dose Interval |
| Standard-Dose Interval ImmunotherapyDuring 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). | Drug | Standard-Dose Interval |
Primary outcome
mPFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Refers to the time from randomization date to the first observation of disease progression (based on RECIST v1.1 criteria) or death from any cause, whichever occurs first.
10 secondary outcomes
mOS
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 years.
DoR
Time frame: From date of achieving CR or PR until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
DDC
Time frame: From date of achieving CR, PR, or SD until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Assessment of quality of life via the EORTC QLQ-C30 questionnaire.
Time frame: 3 years.
Assessment of quality of life via the EORTC QLQ-BR42 questionnaire.
Time frame: 3 years.
Assessment of quality of life via the EQ-5D-5L questionnaire.
Time frame: 3 years.
Assessment of quality of life via the HADS questionnaire.
Time frame: 3 years.
Assessment of quality of life via the FCRI questionnaire.
Time frame: 3 years.
AE
Time frame: 3 years.
Cost-Utility Analysis
Time frame: 3 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 10 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extended-Dose Interval Immunotherapy and Standard-Dose Interval Immunotherapy in people with Triple -Negative Breast Cancer and Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 13 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 10 Feb 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 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 Jieqiong Liu (86-13922272706, liujieqiong01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mPFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.). 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 10 Feb 2026.