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

Primary Purpose

Breast Cancer, Triple Negative Breast Cancer, Camrelizumab

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

（Carrelizumab + TCb） regimen

TCb regimen

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Triple Negative Breast Cancer, Camrelizumab, Neoadjuvant chemotherapy, Pathological complete response rate, Disease-free survival

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18-70 years old
Breast cancer with positive axillary lymph node and primary tumor >1cm confirmed by biopsy；
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；

Exclusion Criteria:

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.

Sites / Locations

Henan cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

（Carrelizumab + TCb） regimen

TCb regimen

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

DFS

Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause

Distant Disease Free Survival (DDFS)

DDFS is defined as the time from surgery to distant recurrence or death from any cause

Objective Response Rate (ORR)

ORR is defined as the number of target lesion responders as assessed by MRI

number of adverse events

Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0

Full Information

NCT ID

NCT05475678

First Posted

July 19, 2022

Last Updated

March 15, 2023

Sponsor

Zhenzhen Liu

1. Study Identification

Unique Protocol Identification Number

NCT05475678

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhenzhen Liu

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Triple Negative Breast Cancer, Camrelizumab

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

369 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

（Carrelizumab + TCb） regimen

Arm Type

Experimental

Arm Description

Arm Title

TCb regimen

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

（Carrelizumab + TCb） regimen

Other Intervention Name(s)

Carrelizumab +docetaxel + carboplatin

Intervention Description

Carrelizumab +docetaxel + carboplatin regimen

Intervention Type

Drug

Intervention Name(s)

TCb regimen

Other Intervention Name(s)

docetaxel + carboplatin

Intervention Description

docetaxel + carboplatin regimen

Primary Outcome Measure Information:

Title

Pathological complete response rate (pCR rate)

Description

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 weeks

Secondary Outcome Measure Information:

Title

Event-Free Survival (EFS)

Description

Time Frame

5-10 years after surgery.

Title

DFS

Description

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 surgery

Title

Distant Disease Free Survival (DDFS)

Description

DDFS is defined as the time from surgery to distant recurrence or death from any cause

Time Frame

5-10 years after surgery

Title

Objective Response Rate (ORR)

Description

ORR is defined as the number of target lesion responders as assessed by MRI

Time Frame

Preoperative

Title

number of adverse events

Description

Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Expression of PD-L1

Description

Differences in the benefits of carelizumab under different PD-L1 expression status

Time Frame

up to 24 weeks

Title

gene mutation rate

Description

Predictive value of polygenic analysis in the population benefiting from camrelizumab

Time Frame

up to 24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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； Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhenzhen Liu

Phone

13603862755

liuzhenzhen73@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dechuang Jiao

Phone

13598004327

jiaodechuang@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhenzhen Liu

Organizational Affiliation

Study Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henan cancer hospital

City

Zhengzhou

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhen Liu

Phone

18603723729

12. IPD Sharing Statement

Learn more about this trial

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

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