Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorZhenzhen Liu
About this trial
Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored.
Camrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety.
Therefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-70 years old
cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
Negative for ER and PR (IHC nuclear staining <10%)
Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
Disqualifiers
The patient has evidence of metastatic breast cancer；
For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
The patient has a second primary malignancy other than adequately treated skin cancer;
The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
Trial design
Design model
Parallel
Treatments tested in this trial
（Carrelizumab + TCb） regimen
DrugCarrelizumab +docetaxel + carboplatin regimen
TCb regimen
Drugdocetaxel + carboplatin regimen
Treatment groups
369 Participants
are divided into 2 treatment groupsGroup A: （Carrelizumab + TCb） regimenExperimental treatment 1 intervention
Group B: TCb regimenPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pathological complete response rate (pCR rate)
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
Time frame
up to 24 weeksSecondary outcomes
1
Event-Free Survival (EFS)
EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause.
Time frame
5-10 years after surgery.2
DFS
Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Time frame
5-10 years after surgery3
Distant Disease Free Survival (DDFS)
DDFS is defined as the time from surgery to distant recurrence or death from any cause
Time frame
5-10 years after surgery4
Objective Response Rate (ORR)
ORR is defined as the number of target lesion responders as assessed by MRI
Time frame
PreoperativeOther outcomes
1
Expression of PD-L1
Differences in the benefits of carelizumab under different PD-L1 expression status
Time frame
up to 24 weeks2
gene mutation rate
Predictive value of polygenic analysis in the population benefiting from camrelizumab
Time frame
up to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhenzhen Liu
Lead sponsor
Henan Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov