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

ConditionTriple-negative Breast Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-65

SponsorHenan Cancer Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

ER and PR negative (IHC nuclear staining<10%)

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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;
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;

Treatment groups

64 Participants

are divided into 2 treatment groups

Group A: 6*Chemotherapy drugs(Nab-P, d1, Cb, d1)+6*Immunosuppressants（d1)Active comparator 1 intervention

Group B: 6*Chemotherapy drugs（Nab-P, d1,8,15, Cb, d1)+6*immunosuppressants（d1, )Active comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

through study completion, an average of 1 year

Secondary outcomes

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;

Time frame

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;

Time frame

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;

Time frame

5 years after surgery

Disease free survival (DDFS)

The time from surgery to distant recurrence or death for any reason;

Time frame

5 years after surgery

Other outcomes

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.

Time frame

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)

Time frame

up to 24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

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