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

NCT07540533 | Recruiting Phase 2

• 1 other identifier: 2025-370
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• PFS

  up to 3 years

• DCR

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

• DoR

  up to 3 years

• OS

  up to 3 years

• Safety (Proportion of AEs)

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

Study Arms (3)

Cohort A

EXPERIMENTAL

Cohort A: triple-negative breast cancer (TNBC) previously treated with immune-checkpoint inhibitors (ICI);

Drug: Toripalimab; Drug: TPC

Cohort B

EXPERIMENTAL

Cohort B: TNBC without prior ICI exposure;

Drug: Toripalimab; Drug: TPC

Cohort C

EXPERIMENTAL

Cohort C: HR-positive/HER2-negative breast cancer.

Drug: Toripalimab; Drug: TPC

Interventions

Toripalimab DRUG

Toripalimab

Cohort A; Cohort B; Cohort C

TPC DRUG

Treatment of Physician's Choice

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• \- 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• Min Yan, Chief physician

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Yan, Chief physician

CONTACT

+86-15713857388; ym200678@126.com

Meng wei Zhang, Associate Chief Physician

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: April 20, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)