Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC

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.

Study Overview

• Status: Recruiting
• Conditions: Triple-negative Breast Cancer
• Intervention / Treatment: Drug: 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1); Drug: 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1)

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhenzhen Liu; Phone Number: 13603862755; Email: liuzhenzhen73@126.com
• Study Contact Backup: Name: Yajie Zhao; Phone Number: 17319303256; Email: Zlyyzhaoyajie4399@zzu.edu.cn

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Zhenzhen Liu; Phone Number: 13603862755; Email: liuzhenzhen73@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 18-65 years old;
2. Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis;

3. 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)

4. Clinically measurable lesions:

   Measurable lesions displayed by ultrasound, mammography, or MR (optional) within one month prior to screening;

5. 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);
6. Cardiac ultrasound EF value ≥ 55%;
7. Women of childbearing age who tested negative for serum pregnancy test 14 days before randomization;
8. ECOG score ≤ 1 point;
9. Voluntary signing of informed consent

Exclusion Criteria:

1. 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);
2. Have Received chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. for this disease;
3. The patient has a second primary malignant tumor, in addition to: fully treated skin cancer;
4. Received treatment with anti-PD-1, anti-PDL1, anti-PD-L2 drugs, or other immunotherapy;
5. Diagnosed with immunodeficiency or autoimmune diseases;
6. Severe lung or heart disease;
7. Hepatitis B and C are in active phase;
8. History of organ transplantation or bone marrow transplantation;
9. Pregnant or lactating women;
10. Due to serious and uncontrollable medical conditions, researchers believe there are contraindications to chemotherapy;
11. Screening for clinically significant bleeding symptoms or significant bleeding tendencies within the previous month;
12. Screening for arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism that occurred within the previous 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 6*Chemotherapy drugs(Nab-P, d1, Cb, d1)+6*Immunosuppressants（d1); Group A： 6*Albumin-bound paclitaxe (260 mg/m²,d 1)+6*Carboplatin (AUC=5, d 1)+6*Camrelizumab (200 mg, d 1);	Drug: 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (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; Other Names: 6*Albumin-bound paclitaxe (d 1)+6*Carboplatin ( d 1)+6*Camrelizumab (d 1)
Active Comparator: 6*Chemotherapy drugs（Nab-P, d1,8,15, Cb, d1)+6*immunosuppressants（d1, ); 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);	Drug: 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (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; Other Names: 6*Albumin-bound paclitaxe (d 1,8,15)+6*Carboplatin ( d 1)+6*Camrelizumab (d 1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	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;	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;	5 years after surgery
Disease free survival (DDFS)	The time from surgery to distant recurrence or death for any reason;	5 years after surgery
Incidence of treatment-emergent adverse events	Evaluate the nature, incidence, and severity of adverse events according to CTCAE 5.0.	After each cycle of chemotherapy (21 days as 1 cycle)]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of the tumor microenvironment with treatment response	Multiple immunofluorescence: CD3+CD4+PD1+KI67; CD3+CD8+PD1+KI67; GZMB; TCF-1; CD31; NG-2 in tumor tissue.	up to 24 weeks
Association of peripheral blood lymphocyte subsets and cytokines with treatment response	Flow cytometric assessment of peripheral blood lymphocyte subsets: CD3+CD4+PD1+KI67; CD3+CD8+PD1+KI67 and Detection of peripheral blood cytokines: vascular endothelial growth factor (VEGF), angiopoietin-2 (ANG-2), basic fibroblast growth factor (bFGF), transforming growth factor-β1 (TGF-β1), and endostatin (ES)	up to 24 weeks

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Investigators: Principal Investigator: Zhenzhen Liu, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Neoadjuvant therapy; Triple-negative breast cancer; Camrelizumab; Pathological complete remission rate
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Carboplatin
• Other Study ID Numbers: HELEN-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No