Breast CancerPhase 2NeoTOPNCT06618014
Neoadjuvant Toripalimab Plus Docetaxel and Carboplatin in Patients With Localized TNBC (NeoTOP)
A Phase 2 study testing Toripalimab, Docetaxel and Carboplatin in people with Breast Cancer and Triple Negative Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus docetaxel and carboplatin in patients with localized triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Toripalimab, Docetaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2022to 31 Dec 2027
- 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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed TNBC. ER and PR negatives are defined as < 10% of cells expressing hormone receptors by IHC analysis. HER2 negative is defined as IHC 0 or 1+, or ISH-negative.
- Treatment-naive clinical stage T1-4N1-N3 or T2-4N0 localized TNBC.
- Female patients aged ≥18 years, < 70 years.
- Able to comply with the required protocol and follow-up procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥12 weeks.
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- Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥90 x 109/L, and Hemoglobin ≥90 g/L (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 1.5 x ULN.
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 50 ml/min.
- Subjects should not be pregnant or breast-feeding.
Who cannot join
- Inflammatory breast cancer or stage IV breast cancer.
- Prior systemic antitumor treatment for any malignancy, including chemotherapy, radiotherapy, immunotherapy and targeted therapy.
- History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Inability to comply with protocol or study procedures.
- Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll.
- Previous history of interstitial lung disease/pneumonia.
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- Patient who has had an allogeneic tissue/solid organ transplant.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Women who are pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Arm Phase II Trial of Neoadjuvant Toripalimab, Docetaxel, Plus Carboplatin in Patients With Localized Triple-Negative Breast Cancer
This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus docetaxel and carboplatin in patients with localized triple-negative breast cancer.
Read the detailed description
Neoadjuvant chemotherapy combined with immunotherapy is the recommended therapeutic approach for patients with localized triple-negative breast cancer (TNBC). The combination regimen improved the pCR rate of triple negative breast cancer, but its side effects also increased. In the KEYNOTE-522 trial, 78% of patients receiving pembrolizumab combined with anthracycline and paclitaxel chemotherapy experienced grade 3 or higher adverse reactions, while the incidence of grade 3 or higher adverse events for patients receiving tislelizumab plus nab-paclitaxel and carboplatin in the CTRIO study was 53.2%. Toripalimab (an anti PD-1 monoclonal) combined with paclitaxel (albumin binding type) for first-line treatment of recurrent or metastatic TNBC was recently approved based on the results from the TORCHLIGHT study. This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus docetaxel and carboplatin in patients with localized TNBC.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Toripalimab, Docetaxel, Carboplatin
- Keywords
- TNBC, neoadjuvant, immunotherapy
- Medical subject headings
- Breast Neoplasms, 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 was given 240 mg intravenously on day 1 of each 21-day cycle for 6 cycles.
DocetaxelDrug
Docetaxel was administered at a dose of 75 mg/m2 on day 1 of each 21-day cycle for 6 cycles.
CarboplatinDrug
Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 4 on day 1 of each 21-day cycle for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant TCb+Toripalimab | Experimental | Patients receive toripalimab (240 mg) plus docetaxel and carboplatin (AUC=4) on day 1 of each 21-day cycle for 6 cycles. Receives: Drug: Toripalimab; Drug: Docetaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
The number of patients with pCR out of the total number of participants using a definition of ypT0/Tis ypN0 after neoadjuvant therapy and surgery.
Measured: 1 week after surgery
Secondary outcomes (4)
Rate of Residual Cancer Burden (RCB) of 0-1
The number of patients with RCB of 0-1 after neoadjuvant therapy and surgery.
Measured: 1 year
Objective Response Rate (ORR)
The number of patients with complete response and partial response out of the total number of participants.
Measured: 1 year
Event-Free Survival (EFS)
EFS was defined as the time from registration to disease progression (local relapse or distant metastases) or death from any cause, whichever came first.
Measured: 3 years after the last patient is enrolled
Safety of the combination therapy
Adverse events (AEs) were graded according to NCI CTCAE v5.0.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start11 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si-Yu Wang, Sun Yat-sen University
- Investigators
- Jun Tang, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618014
- Sponsor's protocol ID
- NeoTOP
- Acronym
- NeoTOP
- Status last verified
- May 2026
- First submitted
- 26 Sep 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Statistical Analysis Plan (SAP) will be shared with other researchers after publication of the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Trial of Neoadjuvant Toripalimab, Docetaxel, Plus Carboplatin in Patients With Localized Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06618014
- Acronym / sponsor ID
- NeoTOP / NeoTOP
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Keywords
- TNBC, neoadjuvant, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Oct 2024 (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 investigate efficacy and safety of neoadjuvant toripalimab plus docetaxel and carboplatin in patients with localized triple-negative breast cancer.
Detailed description
Neoadjuvant chemotherapy combined with immunotherapy is the recommended therapeutic approach for patients with localized triple-negative breast cancer (TNBC). The combination regimen improved the pCR rate of triple negative breast cancer, but its side effects also increased. In the KEYNOTE-522 trial, 78% of patients receiving pembrolizumab combined with anthracycline and paclitaxel chemotherapy experienced grade 3 or higher adverse reactions, while the incidence of grade 3 or higher adverse events for patients receiving tislelizumab plus nab-paclitaxel and carboplatin in the CTRIO study was 53.2%. Toripalimab (an anti PD-1 monoclonal) combined with paclitaxel (albumin binding type) for first-line treatment of recurrent or metastatic TNBC was recently approved based on the results from the TORCHLIGHT study. This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus docetaxel and carboplatin in patients with localized TNBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant TCb+Toripalimab | Experimental | Drug: Toripalimab, Drug: Docetaxel, Drug: CarboplatinPatients receive toripalimab (240 mg) plus docetaxel and carboplatin (AUC=4) on day 1 of each 21-day cycle for 6 cycles. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed TNBC. ER and PR negatives are defined as < 10% of cells expressing hormone receptors by IHC analysis. HER2 negative is defined as IHC 0 or 1+, or ISH-negative.
- Treatment-naive clinical stage T1-4N1-N3 or T2-4N0 localized TNBC.
- Female patients aged ≥18 years, < 70 years.
- Able to comply with the required protocol and follow-up procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (13 listed)
- Inflammatory breast cancer or stage IV breast cancer.
- Prior systemic antitumor treatment for any malignancy, including chemotherapy, radiotherapy, immunotherapy and targeted therapy.
- History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Inability to comply with protocol or study procedures.
- Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll.
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 was given 240 mg intravenously on day 1 of each 21-day cycle for 6 cycles. | Drug | Neoadjuvant TCb+Toripalimab |
| DocetaxelDocetaxel was administered at a dose of 75 mg/m2 on day 1 of each 21-day cycle for 6 cycles. | Drug | Neoadjuvant TCb+Toripalimab |
| CarboplatinCarboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 4 on day 1 of each 21-day cycle for 6 cycles. | Drug | Neoadjuvant TCb+Toripalimab |
Primary outcome
Pathological complete response (pCR) rate
Time frame: 1 week after surgery
The number of patients with pCR out of the total number of participants using a definition of ypT0/Tis ypN0 after neoadjuvant therapy and surgery.
4 secondary outcomes
Rate of Residual Cancer Burden (RCB) of 0-1
Time frame: 1 year
Objective Response Rate (ORR)
Time frame: 1 year
Event-Free Survival (EFS)
Time frame: 3 years after the last patient is enrolled
Safety of the combination therapy
Time frame: 1 year
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 15 May 2026.
- Individual participant dataSharing planned: Yes. Study Protocol and Statistical Analysis Plan (SAP) will be shared with other researchers after publication of the study.
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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. This study is not recruiting at the moment.
Jun Tang, MD principal investigator
Sun Yat-Sen University Cancer Center
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 Toripalimab, Docetaxel and Carboplatin in people with Breast Cancer and Triple Negative Breast Cancer, run by 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 10 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 15 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: 1 week after surgery). 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 15 May 2026.