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

NCT06817525 | Recruiting Phase 2

• 1 other identifier: HELEN-020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple-negative Breast Cancer

Keywords

Pathological complete remission rate; Triple-negative breast cancer; Camrelizumab; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective response rate (ORR)

  up to 24 weeks

• Event-Free Survival (EFS)

  5 years after surgery

• Disease free survival (DFS)

  5 years after surgery

• Disease free survival (DDFS)

  5 years after surgery

• Incidence of treatment-emergent adverse events

  After each cycle of chemotherapy (21 days as 1 cycle)]

Other Outcomes (2)

• Association of the tumor microenvironment with treatment response

  up to 24 weeks

• Association of peripheral blood lymphocyte subsets and cytokines with treatment response

  up to 24 weeks

Study Arms (2)

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);

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);

Drug: 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1)

Interventions

6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1) DRUG

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;

Also known as: 6*Albumin-bound paclitaxe (d 1)+6*Carboplatin ( d 1)+6*Camrelizumab (d 1)

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) DRUG

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;

Also known as: 6*Albumin-bound paclitaxe (d 1,8,15)+6*Carboplatin ( d 1)+6*Camrelizumab (d 1)

6*Chemotherapy drugs（Nab-P, d1,8,15, Cb, d1)+6*immunosuppressants（d1, )

Eligibility Criteria

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

You may qualify if:

• 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)
• 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；

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhenzhen Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Liu

CONTACT

13603862755; liuzhenzhen73@126.com

Yajie Zhao

CONTACT

17319303256; Zlyyzhaoyajie4399@zzu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: February 10, 2025
• Study Start: November 6, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (1)