Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chidamide combined with Zimberelimab

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Chidamide plus Zimberelimab

Eligibility Criteria

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

Inclusion Criteria: Histological confirmation of triple-negative breast cancer on primary tumour at diagnosis/on biopsy of metastasis. At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Fail first-line or above anti-tumor treatment. Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve. Compliance with the study protocol. Have provided written and signed informed consent. Minimum life expectancy 16 weeks. Exclusion Criteria: Pregnant or breast feeding. Uncontrolled medical problems. Evidence of active acute or chronic infection. Hepatic, renal, cardiac, or bone marrow dysfunction. Concurrent malignancy or history of other malignancy within the last five years. Known severe hypersensitivity to Chidamide or Zimberelimab Patients were unable or unwilling to comply with program requirements.

Sites / Locations

Sun Yat-sen University, Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

Chidamide and Zimberelimab

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)

The proportion of patients with measurable tumor size reduction of a predefined amount (complete response [CR], partial response [PR]) according to the response evaluation criteria in solid tumors (RECIST) version 1.1. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Secondary Outcome Measures

Clinical benefit rate (CBR)

The proportion of patients with measurable tumor size stable lasting ≥24 weeks (stable disease [SD]) or its size reduction of a predefined amount (complete response [CR], partial response [PR]) following the response evaluation criteria in solid tumors (RECIST) version 1.1. Complete Response (CR) and Partial Response (PR) are defined in Primary Outcome Measure. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum diameters while on study. Progressive Disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). (Note: the appearance of one or more new lesions is also considered progression).

Progression Free Survival (PFS)

The interval time from the date of initiation treatment for metastatic breast cancer to the date of the first documented disease progression or death due to any cause.

Overall Survival (OS)

The interval time from the date of initiation treatment for metastatic breast cancer to the date of death from any cause.

Occurrence and severity of AEs

Occurrence and severity of AEs by NCI-CTCAE v5. Changes in laboratory parameters (hematology and serum chemistry), vital signs and ECG parameters. Grade 3 or 4 abnormalities in serum chemistry laboratory parameters.

Full Information

NCT ID

NCT05632848

First Posted

November 6, 2022

Last Updated

November 20, 2022

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05632848

Brief Title

Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients

Official Title

The Efficacy and Safety of Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients: A Single-armed, Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy.

Detailed Description

This is a phase II, single center, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy. This study plans to recruit 47 subjects.

6. Conditions and Keywords

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

Triple Negative Breast Cancer

Keywords

Chidamide plus Zimberelimab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Chidamide and Zimberelimab

Intervention Type

Drug

Intervention Name(s)

Chidamide combined with Zimberelimab

Other Intervention Name(s)

Chidamide (Tucidinostat)

Intervention Description

Chidamide: 30mg each time, orally, biw; Zimberelimab, 240mg, IV, every 3 weeks.

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR)

Description

The proportion of patients with measurable tumor size reduction of a predefined amount (complete response [CR], partial response [PR]) according to the response evaluation criteria in solid tumors (RECIST) version 1.1. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Clinical benefit rate (CBR)

Description

The proportion of patients with measurable tumor size stable lasting ≥24 weeks (stable disease [SD]) or its size reduction of a predefined amount (complete response [CR], partial response [PR]) following the response evaluation criteria in solid tumors (RECIST) version 1.1. Complete Response (CR) and Partial Response (PR) are defined in Primary Outcome Measure. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum diameters while on study. Progressive Disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). (Note: the appearance of one or more new lesions is also considered progression).

Time Frame

18 months

Title

Progression Free Survival (PFS)

Description

The interval time from the date of initiation treatment for metastatic breast cancer to the date of the first documented disease progression or death due to any cause.

Time Frame

24 months

Title

Overall Survival (OS)

Description

The interval time from the date of initiation treatment for metastatic breast cancer to the date of death from any cause.

Time Frame

30 months

Title

Occurrence and severity of AEs

Description

Occurrence and severity of AEs by NCI-CTCAE v5. Changes in laboratory parameters (hematology and serum chemistry), vital signs and ECG parameters. Grade 3 or 4 abnormalities in serum chemistry laboratory parameters.

Time Frame

30 months

Other Pre-specified Outcome Measures:

Title

Biomarkers related to efficacy

Description

Baseline tumor biopsy from metastatic or recurrent lesions was required, we analyze and compare the difference of tumor immune microenvironment among patients with different responses to this intervention via the single cell sequencing of acquired tumor biopsy. And peripheral blood samples were collected at baseline, one day before the second cycle treatment and the date of withdrawal from this clinical trial confirmed by researchers. Then peripheral blood mononuclear cell cluster analysis will be performed and compared their changes before and after treatment.

Time Frame

24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Histological confirmation of triple-negative breast cancer on primary tumour at diagnosis/on biopsy of metastasis. At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Fail first-line or above anti-tumor treatment. Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve. Compliance with the study protocol. Have provided written and signed informed consent. Minimum life expectancy 16 weeks. Exclusion Criteria: Pregnant or breast feeding. Uncontrolled medical problems. Evidence of active acute or chronic infection. Hepatic, renal, cardiac, or bone marrow dysfunction. Concurrent malignancy or history of other malignancy within the last five years. Known severe hypersensitivity to Chidamide or Zimberelimab Patients were unable or unwilling to comply with program requirements.

Central Contact Person:

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

Zhong-yu Yuan, M.D.

Phone

862087342794

Email

yuanzhy@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhong-yu Yuan, M.D.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

Sun Yat-sen University, Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuan Zhong-yu, MD

Phone

86-20-87342496

Email

yuanzhy@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Huang Jia-Jia, MD

Phone

86-20-87343794

Email

huangjiaj@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Yuan Zhong-yu, MD

First Name & Middle Initial & Last Name & Degree

Huang Jia-Jia, MD

Triple Negative Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial