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

Official title

Nab-P+Cb+PD1 Inhibitor Neoadjuvant Therapy for Early TNBC: a Single Center, Non Blinded, Randomized Phase II Clinical Trial

Overview

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

Interventions

• 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;
• 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;

Primary outcome measures

• Pathological Complete Response rate(pCR) [Time frame: through study completion, an average of 1 year]

Secondary outcome measures (5)

• 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)]]

Eligibility criteria

Inclusion criteria

• 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；
• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Henan cancer hospital — Zhengzhou

Identifiers

NCT: NCT06817525 · HELEN-020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗