TNBC - Triple-Negative Breast CancerPhase 2NCT07256964
Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer
A Phase 2 study testing Toripalimab, PCb-EC and PCb in people with TNBC - Triple-Negative Breast Cancer, run by Henan Cancer Hospital.
Trial summary
This study aims to evaluate the efficacy and safety of a PD-1 inhibitor combined with different chemotherapy regimens (PCb-EC and PCb), in order to develop a superior and well-tolerated neoadjuvant therapeutic strategy for patients with triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Toripalimab, PCb-EC and PCb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 26 Nov 2025to 31 Dec 2033
- 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
- Age: 18-70 years.
- Disease Status: Clinical pathological confirmation of cT2-cT4d, or cT1c with axillary lymph node metastasis.
- Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma.
- Definition of Triple-Negative Breast Cancer:
- ER and PR negative (IHC nuclear staining <10%).
- Her-2 negative (IHC 0 or 1+ without FISH, or IHC 2+ with FISH demonstrating no amplification).
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- Measurable Disease: Presence of clinically measurable lesion(s) confirmed by ultrasound, mammography, or optional MRI within 1 month prior to randomization.
- Adequate Organ and Bone Marrow Function (within 1 month prior to chemotherapy), indicating no contraindications for chemotherapy:
- Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L
- Hemoglobin (Hb) ≥ 90 g/L
- Platelet count (PLT) ≥ 100 × 10⁹/L
- Total Bilirubin (TBIL) < 1.5 × ULN (Upper Limit of Normal)
- Serum Creatinine (Cr) < 1.5 × ULN
- Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) < 1.5 × ULN
- Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram.
- Pregnancy Status: For women of childbearing potential, a negative serum pregnancy test within 14 days prior to randomization.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
- Informed Consent: Signed informed consent obtained.
Who cannot join
- Metastatic Disease: Evidence of metastatic breast cancer. (To exclude metastasis, CT scans of the chest and abdomen, and a bone scan must be performed at any time point from diagnosis to randomization; PET/CT may serve as an alternative imaging modality).
- Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.
- Second Primary Malignancy: Presence of a second primary malignancy, except for:
- Adequately treated non-melanoma skin carcinoma.
- Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy.
- Immunodeficiency or Autoimmune Disease: Diagnosed immunodeficiency or active autoimmune disease requiring systemic treatment.
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- Severe Comorbidities: Severe or uncontrolled pulmonary or cardiac disease.
- Active Hepatitis: Active Hepatitis B or Hepatitis C infection.
- Transplantation History: History of solid organ or bone marrow transplantation.
- Pregnancy/Lactation: Pregnant or lactating women.
- Other Medical Conditions: Any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Randomized Controlled, Multicenter Phase II Clinical Study of Toripalimab Combined With PCb-EC Regimen (Albumin Paclitaxel + Carboplatin Followed by Epirubicin + Cyclophosphamide) or PCb Regimen (Albumin Paclitaxel + Carboplatin) as Neoadjuvant Therapy for Triple-Negative Breast Cancer
This study aims to evaluate the efficacy and safety of a PD-1 inhibitor combined with different chemotherapy regimens (PCb-EC and PCb), in order to develop a superior and well-tolerated neoadjuvant therapeutic strategy for patients with triple-negative breast cancer.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- Toripalimab, PCb-EC, PCb
- Keywords
- PD1, TNBC, Neoadjuvant chemotherapy
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Toripalimab 240mg every cycle
PCb-ECDrug
Albumin Paclitaxel + Carboplatin*4 Followed by Epirubicin + Cyclophosphamide*4
PCbDrug
Albumin Paclitaxel + Carboplatin *6
| Study group | Role | What they receive |
|---|---|---|
| PCb-EC+PD1 | Active comparator | Not described Receives: Drug: Toripalimab; Drug: PCb-EC |
| PCb+PD1 | Experimental | Not described Receives: Drug: Toripalimab; Drug: PCb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR) rates
Measured: Up to 180 days
Secondary outcomes (7)
Objective response rate（ORR）
Measured: up to 180 days
Event-free survival (EFS)
Measured: up to 5 years
Invasive Disease-Free Survival (IDFS)
Measured: up to 5 years
Overall Survival (OS)
Measured: up to 5 years
Adverse events
Measured: up to 18 months
EORTC QLQ-C30 questionnaire
All of the scales and single-item measures range in score from 0 to 100. A high scale scorerepresents a higher response level
Measured: up to 18 months
EORTC QLQ-BR23 questionnaire
All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning,
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start26 Nov 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256964
- Sponsor's protocol ID
- HELEN-TRIO-TORI
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie the results of the study will be made avaliable after de-indentification.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled, Multicenter Phase II Clinical Study of Toripalimab Combined With PCb-EC Regimen (Albumin Paclitaxel + Carboplatin Followed by Epirubicin + Cyclophosphamide) or PCb Regimen (Albumin Paclitaxel + Carboplatin) as Neoadjuvant Therapy for Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07256964
- Acronym / sponsor ID
- HELEN-TRIO-TORI
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Keywords
- PD1, TNBC, Neoadjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 26 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 2 Dec 2025 (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.
This study aims to evaluate the efficacy and safety of a PD-1 inhibitor combined with different chemotherapy regimens (PCb-EC and PCb), in order to develop a superior and well-tolerated neoadjuvant therapeutic strategy for patients with triple-negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCb-EC+PD1 | Active comparator | Drug: Toripalimab, Drug: PCb-EC |
| PCb+PD1 | Experimental | Drug: Toripalimab, Drug: PCb |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age: 18-70 years.
- Disease Status: Clinical pathological confirmation of cT2-cT4d, or cT1c with axillary lymph node metastasis.
- Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma.
- Definition of Triple-Negative Breast Cancer:
- ER and PR negative (IHC nuclear staining <10%).
Key exclusion criteria (11 listed)
- Metastatic Disease: Evidence of metastatic breast cancer. (To exclude metastasis, CT scans of the chest and abdomen, and a bone scan must be performed at any time point from diagnosis to randomization; PET/CT may serve as an alternative imaging modality).
- Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.
- Second Primary Malignancy: Presence of a second primary malignancy, except for:
- Adequately treated non-melanoma skin carcinoma.
- Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy.
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 |
|---|---|---|
| ToripalimabToripalimab 240mg every cycle | Drug | PCb+PD1, PCb-EC+PD1 |
| PCb-ECAlbumin Paclitaxel + Carboplatin*4 Followed by Epirubicin + Cyclophosphamide*4 | Drug | PCb-EC+PD1 |
| PCbAlbumin Paclitaxel + Carboplatin *6 | Drug | PCb+PD1 |
Primary outcome
Pathologic complete response (pCR) rates
Time frame: Up to 180 days
7 secondary outcomes
Objective response rate（ORR）
Time frame: up to 180 days
Event-free survival (EFS)
Time frame: up to 5 years
Invasive Disease-Free Survival (IDFS)
Time frame: up to 5 years
Overall Survival (OS)
Time frame: up to 5 years
Adverse events
Time frame: up to 18 months
EORTC QLQ-C30 questionnaire
Time frame: up to 18 months
EORTC QLQ-BR23 questionnaire
Time frame: up to 18 months
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 2 Dec 2025.
- Individual participant dataSharing planned: Yes. IPD that underlie the results of the study will be made avaliable after de-indentification.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab, PCb-EC and PCb in people with TNBC - Triple-Negative Breast Cancer, run by Henan Cancer Hospital.
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 18 inclusion and 11 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: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Zhenzhen Liu (+8613603862755, zlyyliuzhenzhen0800@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (pCR) rates (time frame: Up to 180 days). 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 2 Dec 2025.