Clinical trial NCT05475678: Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer
Official title: A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Triple Negative Breast Cancer
Camrelizumab
Keywords: Triple Negative Breast Cancer
Camrelizumab
Neoadjuvant chemotherapy
Pathological complete response rate
Disease-free survival
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-27
Enrollment: 369
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The enrolled patients were randomly assigned to the experimental group and the control group in a ratio of 2:1.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study mainly compared the efficacy and safety of 6\*TCb (docetaxel+carboplatin)+carrelizumab regimen and 6\*TCb regimen in neoadjuvant chemotherapy for triple-negative breast cancer.

Patients who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 2:1 ratio.

* The experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle.
* The control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle.

The efficacy and safety of the two chemotherapy regimens on neoadjuvant chemotherapy for triple-negative breast cancer were evaluated by PCR, EFS, DFS, DDFS and ORR after surgery.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-70 years old
2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
3. Pathologically proven triple negative breast cancer:

   Triple-negative breast cancer is defined as:
   * 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)；
4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
6. Cardiac ultrasound EF value ≧55%；
7. Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
8. ECOG score≤1 point;
9. Sign informed consent；

Exclusion Criteria:

1. The patient has evidence of metastatic breast cancer；
2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
3. The patient has a second primary malignancy other than adequately treated skin cancer;
4. 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；
5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
6. The patient has severe lung or heart disease;
7. The patient has active hepatitis B and C;
8. The patient has a history of organ transplantation or bone marrow transplantation;
9. pregnant or breastfeeding women;
10. The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.

Primary outcomes:
measure: Pathological complete response rate (pCR rate)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Event-Free Survival (EFS)
timeFrame: 5-10 years after surgery.
measure: DFS
timeFrame: 5-10 years after surgery
measure: Distant Disease Free Survival (DDFS)
timeFrame: 5-10 years after surgery
measure: Objective Response Rate (ORR)
timeFrame: Preoperative
measure: number of adverse events
timeFrame: After each cycle of chemotherapy (21 days as 1 cycle)
Other outcomes:
measure: Expression of PD-L1
timeFrame: up to 24 weeks
measure: gene mutation rate
timeFrame: up to 24 weeks
Locations:
city: Zhengzhou
country: China
facility: Henan cancer hospital
state: Henan
Study officials:
affiliation: Study Principal Investigator
name: Zhenzhen Liu
role: PRINCIPAL_INVESTIGATOR
References: