Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer

NCT05475678 | Recruiting Phase 2 DMC

• 1 other identifier: HELEN-011
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Triple Negative Breast Cancer; Camrelizumab

Keywords

Triple Negative Breast Cancer; Camrelizumab; Neoadjuvant chemotherapy; Pathological complete response rate; Disease-free survival

Outcome Measures

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)

  up to 24 weeks

Secondary Outcomes (5)

• Event-Free Survival (EFS)

  5-10 years after surgery.

• DFS

  5-10 years after surgery

• Distant Disease Free Survival (DDFS)

  5-10 years after surgery

• Objective Response Rate (ORR)

  Preoperative

• number of adverse events

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

Other Outcomes (2)

• Expression of PD-L1

  up to 24 weeks

• gene mutation rate

  up to 24 weeks

Study Arms (2)

（Carrelizumab + TCb） regimen

EXPERIMENTAL

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.

Drug: （Carrelizumab + TCb） regimen

TCb regimen

PLACEBO COMPARATOR

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.

Drug: TCb regimen

Interventions

（Carrelizumab + TCb） regimen DRUG

Carrelizumab +docetaxel + carboplatin regimen

Also known as: Carrelizumab +docetaxel + carboplatin

（Carrelizumab + TCb） regimen

TCb regimen DRUG

docetaxel + carboplatin regimen

Also known as: docetaxel + carboplatin

TCb regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years old
• cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
• 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)；
• Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
• Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
• Cardiac ultrasound EF value ≧55%；
• Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
• ECOG score≤1 point;
• Sign informed consent；

You may not qualify if:

• 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；
• The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
• The patient has severe lung or heart disease;
• The patient has active hepatitis B and C;
• The patient has a history of organ transplantation or bone marrow transplantation;
• pregnant or breastfeeding women;
• The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.

Sponsors & Collaborators

• Zhenzhen Liu: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

camrelizumab; Carboplatin; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Zhenzhen Liu

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Liu

CONTACT

13603862755; liuzhenzhen73@126.com

Dechuang Jiao

CONTACT

13598004327; jiaodechuang@163.com

Study Design

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

Model Details: The enrolled patients were randomly assigned to the experimental group and the control group in a ratio of 2:1.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 27, 2022
• Study Start: December 20, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

CN (1)