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Advanced Breast CancerPhase 22025-370NCT07540533

A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer

A Phase 2 study testing Toripalimab and TPC in people with Advanced Breast Cancer, run by Henan Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To evaluate the efficacy and safety of toripalimab in combination with investigator-selected chemotherapy in patients with recurrent or metastatic HER2-negative breast cancer who have failed prior systemic therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Breast Cancer
What is being tested?
Toripalimab and TPC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteChina
Study dates
20 Jan 2026to Aug 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation: the subject must give written informed consent, be compliant, and agree to attend all follow-up visits.
  • Age ≥ 18 years.
  • ECOG performance-status score ≤ 1 and life expectancy ≥ 3 months.
  • Histologically or cytologically confirmed HER2-negative breast cancer (HER2-negative is defined as either IHC 0, IHC 1+, or IHC 2+ with a negative in-situ-hybridisation [ISH] result).
  • For subjects with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC):
  • Must have experienced progression during/after at least one prior systemic regimen for recurrent/metastatic disease (recurrence ≤ 12 months after neoadjuvant/adjuvant therapy counts as first-line failure).
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  • Cohort assignment by prior immune-checkpoint-inhibitor (ICI) exposure:
  • Cohort A - ICI-pretreated:
  • If ICI was given in adjuvant setting, recurrence must occur ≥ 12 months after completion of immunotherapy.
  • If ICI was given in neoadjuvant or metastatic setting, best overall response must have met clinical-benefit criteria (PR, CR, or SD > 24 weeks).
  • Cohort B - ICI-naïve: no prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other antibody targeting T-cell co-stimulatory or checkpoint pathways.
  • For subjects with hormone-receptor-positive (HR+) breast cancer:
  • Must have progressed after ≥ 2 prior endocrine regimens in the recurrent/metastatic setting (unless investigator judges no endocrine benefit), and
  • Must have progressed after ≥ 1 prior systemic chemotherapy for recurrent/metastatic disease (recurrence ≤ 12 months after adjuvant/neoadjuvant therapy counts as first-line failure).
  • At least one measurable lesion per RECIST v1.1.
  • Adequate organ function, defined as:
  • Haematology (no transfusion within 14 days):
  • Haemoglobin ≥ 9 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
  • Platelet count ≥ 100 × 10⁹/L . Serum chemistry:
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  • Total bilirubin ≤ 1.5 × ULN, or if total bilirubin > ULN then direct bilirubin ≤ ULN
  • ALT and AST ≤ 2.5 × ULN
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min
  • Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days before first dose and must use highly effective contraception from first dose until 6 months after last dose.
  • WOCBP is defined as any sexually mature female who has not undergone hysterectomy or bilateral oophorectomy and who has not experienced natural amenorrhoea for ≥ 24 consecutive months (including women with treatment-induced amenorrhoea).Men whose partners are WOCBP must also use effective contraception during the same period.

Who cannot join

  • Uncontrolled central-nervous-system metastases (symptomatic or requiring corticosteroids or mannitol for symptom control).
  • Clinically significant or uncontrolled cardiac disease within 6 months before first dose, including congestive heart failure, angina, myocardial infarction, or ventricular arrhythmia.
  • Malignancy within 5 years before first dose, except adequately treated basal-cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Active autoimmune disease requiring systemic therapy within 2 years before first dose, except vitiligo, type-1 diabetes, or residual hypothyroidism due to autoimmune thyroiditis managed with hormone replacement only.
  • Uncontrolled pleural, pericardial, or ascitic fluid requiring repeated drainage.
  • Documented human immunodeficiency virus (HIV) infection.
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  • Documented hepatitis-B infection or active hepatitis-C infection.
  • Prior hypersensitivity to any component or excipient of the investigational product(s).
  • Any condition judged by the investigator to render the patient unsuitable for trial participation.

Trial locations and contacts

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

Min Yan, Chief physician contact

+86-15713857388

ym200678@126.com

Meng wei Zhang, Associate Chief Physician contact

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Min Yan, Chief physician, +86-15713857388, ym200678@126.com

    Meng wei Zhang, Associate Chief Physician

    Recruiting

Other trials in China

About this study

To evaluate the efficacy and safety of toripalimab in combination with investigator-selected chemotherapy in patients with recurrent or metastatic HER2-negative breast cancer who have failed prior systemic therapy.

Being tested
Toripalimab, TPC

What participants receive

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

  • ToripalimabDrug

    Toripalimab

  • TPCDrug

    Treatment of Physician's Choice

Study groups in NCT07540533
Study groupRoleWhat they receive
Cohort AExperimentalCohort A: triple-negative breast cancer (TNBC) previously treated with immune-checkpoint inhibitors (ICI);
Receives: Drug: Toripalimab; Drug: TPC
Cohort BExperimentalCohort B: TNBC without prior ICI exposure;
Receives: Drug: Toripalimab; Drug: TPC
Cohort CExperimentalCohort C: HR-positive/HER2-negative breast cancer.
Receives: Drug: Toripalimab; Drug: TPC

What is being measured

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

  1. ORR by investigator

    ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.

    Measured: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks

Secondary outcomes (5)

  1. PFS

    PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression).

    Measured: up to 3 years

  2. DCR

    DCR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1.

    Measured: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks

  3. DoR

    DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.

    Measured: up to 3 years

  4. OS

    OS is the time from the date of first dose until the date of death by any cause.

    Measured: up to 3 years

  5. Safety (Proportion of AEs)

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE.

    Measured: from time of informed consent provided to 30 days after the last dose of study therapy

Timeline

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

  1. First posted20 Apr 2026
  2. Study start20 Jan 2026
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07540533
Sponsor's protocol ID
2025-370
Acronym
2025-370
Status last verified
Apr 2026
First submitted
30 Dec 2025
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab and TPC in people with Advanced Breast Cancer, run by Henan Cancer Hospital 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 26 inclusion and 9 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 20 Apr 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 Min Yan, Chief physician (+86-15713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR by investigator (time frame: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks). 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 NCT07540533.

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 20 Apr 2026.

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