Triple-negative Breast CancerPhase 2NCT06817525
Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC
A Phase 2 study testing 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1) and 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1) in people with Triple-negative Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1) and 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2024to 31 May 2026
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years old;
- Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis;
- Three negative type and invasive breast cancer confirmed by histopathology;
- Three negative breast cancer is defined as:
- ER and PR negative (IHC nuclear staining<10%)
- Her-2 negative (IHC 0, 1+without FISH, or IHC 2+without FISH amplification)
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- Clinically measurable lesions:
- Measurable lesions displayed by ultrasound, mammography, or MR (optional) within one month prior to screening;
- Organ and bone marrow function tests within 2 weeks before chemotherapy indicate no contraindications for chemotherapy:
- Absolute value of neutrophil count ≥ 2.0 × 109/L
- Hemoglobin ≥ 100g/L
- Platelet count ≥ 100 × 109/L
- Total bilirubin<1.5 ULN (upper limit of normal)
- Creatinine<1.5 × ULN
- AST/ALT < 1.5×ULN；
- Thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); If there are abnormalities, T3 and T4 levels should be examined. If T3 and T4 levels are normal, they can be selected
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN, while meeting international standards Normalization ratio (INR) ≤ 1.5 ULN (not receiving anticoagulant therapy);
- Cardiac ultrasound EF value ≥ 55%;
- Women of childbearing age who tested negative for serum pregnancy test 14 days before randomization;
- ECOG score ≤ 1 point;
- Voluntary signing of informed consent
Who cannot join
- There is evidence of metastatic breast cancer (in order to exclude metastatic breast cancer, chest and abdomen CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging inspection method);
- Have Received chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. for this disease;
- The patient has a second primary malignant tumor, in addition to: fully treated skin cancer;
- Received treatment with anti-PD-1, anti-PDL1, anti-PD-L2 drugs, or other immunotherapy;
- Diagnosed with immunodeficiency or autoimmune diseases;
- Severe lung or heart disease;
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- Hepatitis B and C are in active phase;
- History of organ transplantation or bone marrow transplantation;
- Pregnant or lactating women;
- Due to serious and uncontrollable medical conditions, researchers believe there are contraindications to chemotherapy;
- Screening for clinically significant bleeding symptoms or significant bleeding tendencies within the previous month;
- Screening for arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism that occurred within the previous 3 months.
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
Henan cancer hospital
Zhengzhou, Henan
Zhenzhen Liu, 13603862755, liuzhenzhen73@126.com
About this study
Official title: Nab-P+Cb+PD1 Inhibitor Neoadjuvant Therapy for Early TNBC: a Single Center, Non Blinded, Randomized Phase II Clinical Trial
We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.
Read the detailed description
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups (Group A and Group B) at a ratio of 1:1, and stratified according to T stage and N stage. The administration regimen is as follows: Group A： albumin-bound paclitaxe (260 mg/m²,d 1)+Carboplatin (AUC=5, d 1)+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles; Group B: albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+Carboplatin (AUC=5, d 1 )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles
Primary endpoint: Pathological complete response rate (pCR rate).
Secondary study endpoints: Objective response rate (ORR), event free survival rate (EFS), disease-free survival (DFS), distant disease free survival (DDFS), and safety.
Exploratory endpoints: Differences in efficacy and immune microenvironment under different administration methods
- Conditions
- Triple-negative Breast Cancer
- Being tested
- 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1), 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1)
- Keywords
- Pathological complete remission rate, Triple-negative breast cancer, Camrelizumab, Neoadjuvant therapy
- 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.
6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1)Drug
Also called 6*Albumin-bound paclitaxe (d 1)+6*Carboplatin ( d 1)+6*Camrelizumab (d 1)
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage.
Group A： Albumin-bound paclitaxe (260 mg/m²,d 1)+Carboplatin (AUC=5, d 1)+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles;
6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1)Drug
Also called 6*Albumin-bound paclitaxe (d 1,8,15)+6*Carboplatin ( d 1)+6*Camrelizumab (d 1)
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage.
Group B: Albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+Carboplatin (AUC=5, d 1 )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles;
| Study group | Role | What they receive |
|---|---|---|
| 6*Chemotherapy drugs(Nab-P, d1, Cb, d1)+6*Immunosuppressants（d1) | Active comparator | Group A： 6*Albumin-bound paclitaxe (260 mg/m²,d 1)+6*Carboplatin (AUC=5, d 1)+6*Camrelizumab (200 mg, d 1); Receives: Drug: 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1) |
| 6*Chemotherapy drugs（Nab-P, d1,8,15, Cb, d1)+6*immunosuppressants（d1, ) | Active comparator | Group B: 6*Albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+6*Carboplatin (AUC=5, d 1 )+6*Camrelizumab (200 mg, d 1); Receives: Drug: 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response rate(pCR)
Pathological Complete Response (pCR) rate: It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Objective response rate (ORR)
Objective response rate (ORR) based on RECIST v1.1 assessment, defined as the number of target lesion responders evaluated by MRI/ultrasound;
Measured: up to 24 weeks
Event-Free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: disease progression, local or remote recurrence, second primary malignant tumor (breast cancer or other cancers) or death caused by any reason during neoadjuvant treatment;
Measured: 5 years after surgery
Disease free survival (DFS)
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death for any reason;
Measured: 5 years after surgery
Disease free survival (DDFS)
The time from surgery to distant recurrence or death for any reason;
Measured: 5 years after surgery
Incidence of treatment-emergent adverse events
Evaluate the nature, incidence, and severity of adverse events according to CTCAE 5.0.
Measured: After each cycle of chemotherapy (21 days as 1 cycle)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start6 Nov 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (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 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817525
- Sponsor's protocol ID
- HELEN-020
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nab-P+Cb+PD1 Inhibitor Neoadjuvant Therapy for Early TNBC: a Single Center, Non Blinded, Randomized Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06817525
- Acronym / sponsor ID
- HELEN-020
- Conditions
- Triple-negative Breast Cancer
- Keywords
- Pathological complete remission rate, Triple-negative breast cancer, Camrelizumab, Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 10 Feb 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.
We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.
Detailed description
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups (Group A and Group B) at a ratio of 1:1, and stratified according to T stage and N stage. The administration regimen is as follows: Group A： albumin-bound paclitaxe (260 mg/m²,d 1)+Carboplatin (AUC=5, d 1)+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles; Group B: albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+Carboplatin (AUC=5, d 1 )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles
Primary endpoint: Pathological complete response rate (pCR rate).
Secondary study endpoints: Objective response rate (ORR), event free survival rate (EFS), disease-free survival (DFS), distant disease free survival (DDFS), and safety.
Exploratory endpoints: Differences in efficacy and immune microenvironment under different administration methods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6*Chemotherapy drugs(Nab-P, d1, Cb, d1)+6*Immunosuppressants（d1) | Active comparator | Drug: 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1)Group A： 6*Albumin-bound paclitaxe (260 mg/m²,d 1)+6*Carboplatin (AUC=5, d 1)+6*Camrelizumab (200 mg, d 1); |
| 6*Chemotherapy drugs（Nab-P, d1,8,15, Cb, d1)+6*immunosuppressants（d1, ) | Active comparator | Drug: 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1)Group B: 6*Albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+6*Carboplatin (AUC=5, d 1 )+6*Camrelizumab (200 mg, d 1); |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age: 18-65 years old;
- Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis;
- Three negative type and invasive breast cancer confirmed by histopathology;
- Clinically measurable lesions:
- Measurable lesions displayed by ultrasound, mammography, or MR (optional) within one month prior to screening;
Key exclusion criteria (12 listed)
- There is evidence of metastatic breast cancer (in order to exclude metastatic breast cancer, chest and abdomen CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging inspection method);
- Have Received chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. for this disease;
- The patient has a second primary malignant tumor, in addition to: fully treated skin cancer;
- Received treatment with anti-PD-1, anti-PDL1, anti-PD-L2 drugs, or other immunotherapy;
- Diagnosed with immunodeficiency or autoimmune diseases;
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 |
|---|---|---|
| 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1)Also: 6*Albumin-bound paclitaxe (d 1)+6*Carboplatin ( d 1)+6*Camrelizumab (d 1)This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage. Group A： Albumin-bound paclitaxe (260 mg/m²,d 1)+Carboplatin (AUC=5, d 1)+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles; | Drug | 6*Chemotherapy drugs(Nab-P, d1, Cb, d1)+6*Immunosuppressants（d1) |
| 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1)Also: 6*Albumin-bound paclitaxe (d 1,8,15)+6*Carboplatin ( d 1)+6*Camrelizumab (d 1)This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage. Group B: Albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+Carboplatin (AUC=5, d 1 )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles; | Drug | 6*Chemotherapy drugs（Nab-P, d1,8,15, Cb, d1)+6*immunosuppressants（d1, ) |
Primary outcome
Pathological Complete Response rate(pCR)
Time frame: through study completion, an average of 1 year
Pathological Complete Response (pCR) rate: It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
5 secondary outcomes
Objective response rate (ORR)
Time frame: up to 24 weeks
Event-Free Survival (EFS)
Time frame: 5 years after surgery
Disease free survival (DFS)
Time frame: 5 years after surgery
Disease free survival (DDFS)
Time frame: 5 years after surgery
Incidence of treatment-emergent adverse events
Time frame: After each cycle of chemotherapy (21 days as 1 cycle)]
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 5 Dec 2025.
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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.
Zhenzhen Liu principal investigator
Henan Cancer Hospital
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 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1) and 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1) in people with Triple-negative 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 21 inclusion and 12 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 5 Dec 2025. 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 Zhenzhen Liu (13603862755, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response rate(pCR) (time frame: through study completion, an average of 1 year). 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 5 Dec 2025.