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A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer After First-line Chemotherapy

Primary Purpose

HR Positive HER2 Negative Advanced Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HR Positive HER2 Negative Advanced Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal/premenopausal women aged ≥18 years and ≤70 years; HR + / HER2 breast cancer confirmed by histology (note: her2-negative is defined as: (1) IHC1 + / IHC0; ②IHC2+ : FISH-); Confirmed by the histology of locally advanced breast cancer (local treatment) to radical or recurrent metastatic breast cancer; In the late stage of untreated or experienced a CDK4/6 with endocrine therapy of patients; Researchers think that for selecting patients with chemotherapy (step 2022 guidelines recommend for internal transfer, always endocrine therapy resistance or preferred to rescue patients with endocrine therapy best choice of chemotherapy); One line finish cycle disease after chemotherapy (4 to 8 cycles) to alleviate or stable, quasi follow-up maintenance treatment: a. late stage A gleam of unused CDK4/6 inhibitors + endocrine group subjects into the queue for A; b. Used in the late phase line CDK4/6 inhibitors queue B + endocrine subjects into groups; Into the former group at least one measurable lesions (RECIST v1.1 standard); 8.ECOG score 0 to 2 points; 9.Always all the acute toxic reaction caused by antineoplastic therapy in screening before easing to 0 and 1 level (according to the NCI CTCAE 5.0 judgment; Hair loss, other than toxicity that the investigator believes does not pose a safety risk to the subject); 10. Functions: bone marrow neutrophils absolute acuity 1.5 x 109 / L, platelet acuity 100 x 109 / L, 90 g/L or higher hemoglobin; 11. Liver and kidney function: TBIL acuities were 1.5 x ULN; ALT and AST≤2.5 x ULN; In case of liver metastasis, ALT and AST≤ 5×ULN; BUN and Cr≤1.5×ULN and creatinine clearance ≥50 ml/min; 12.Voluntary participation in the clinical trials, signed written informed consent. Exclusion Criteria: Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; Always received HDACi anti-tumor treatment; This scheme known drug components have allergy history; Always with other malignant tumours within five years, not including has cured thyroid papillary carcinoma, cervical carcinoma in situ, basal cell carcinoma or skin squamous cell carcinoma of the skin; Within 4 weeks before into the group participated in other clinical trials; A history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation; Unable to control the important cardiovascular disease: a history of clinical significance of long QT, stage or screen between QTc > 450 ms; Severe cardiovascular injury (greater than a New York Heart Association (NYHA) Class II history of congestive heart failure), unstable angina or myocardial infarction within the last 6 months, or severe arrhythmia; Pregnancy and lactation women patients or in infertile women baseline pregnancy test positive; Or participants of childbearing age who were unwilling to use effective contraception during the study period and for at least 8 weeks after the last dosing; According to the researcher's judgment, there is serious to endanger the safety of patients, the patients completed studies or associated with disease (such as severe hypertension, diabetes, thyroid disease, active infection, etc.); Always have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, etc.; Reference: subjects had active hepatitis (hepatitis b positive HBsAg and HBV DNA of 500 IU/ml or more; Hepatitis C reference: HCV antibody positive and HCV virus copy number > upper limit of normal); The researchers determine doesn't fit to the researchers.

Sites / Locations

  • 天津市肿瘤医院Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A in advanced stages of first-line ± endocrine therapy without CDK4/6 inhibitors

Late-stage first-line ± endocrine therapy with CDK4/6 inhibitors in cohort B

Arm Description

Chidamide tablets, specification 5mg/ tablet. Administration method: Oral, 30mg/ time, twice a week; Endocrine drugs: (TAM, AI, fluvestran, etc.) According to patients' previous endocrine treatment, different endocrine drugs were selected according to researchers' judgment, and the dosage was used according to the instructions; OFS drugs (for premenopausal patients only).

Chidamide tablets, specification 5mg/ tablet. Administration method: Oral, 30mg/ time, twice a week; Endocrine drugs: (TAM, AI, fluvestran, etc.) According to patients' previous endocrine treatment, different endocrine drugs were selected according to researchers' judgment, and the dosage was used according to the instructions; OFS drugs (for premenopausal patients only).

Outcomes

Primary Outcome Measures

Progression-free survival
PFS is defined as the time from the date of treatment to the first date of disease

Secondary Outcome Measures

Objective response rate
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)
Disease control rate
his means that in all patients with a tumor who receive a certain treatment, the tumor shrinks or stays stable, and stays that way for a certain amount of time
Clinical Benefit Rate (CBR)
CBR is defined as the rate of patients who achieved complete response, partial response, and stable disease for >= 24 weeks as the best response of treatment.
Overall Survival (OS)
OS defined as the time from the first study treatment administration to death from any cause
Adverse events (AE)
The level of the adverse event (AE) is analyzed according to the Common Terminology Criteria for Adverse Event (CTCAE) (version 5.0).

Full Information

First Posted
May 11, 2023
Last Updated
May 26, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05890287
Brief Title
A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer After First-line Chemotherapy
Official Title
An Open, Single-center, Exploratory Cohort Study of Chidamide in Combination With Endocrine in Maintenance Therapy After First-line Chemotherapy for HR+/HER2- Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To explore the efficacy and safety of Chidamide combined with endocrine for maintenance therapy after first-line chemotherapy for HR+/HER2- breast cancer
Detailed Description
o explore the efficacy and safety of Chidamide combined with endocrine drug maintenance after first-line chemotherapy in the treatment of advanced untreated breast cancer; To explore the efficacy and safety of Chidamidecombined with endocrine drugs after first-line chemotherapy in the treatment of advanced first-line non-chemotherapeutic breast cancer after failure of CDK4/6 inhibitors

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HR Positive HER2 Negative Advanced Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A in advanced stages of first-line ± endocrine therapy without CDK4/6 inhibitors
Arm Type
Experimental
Arm Description
Chidamide tablets, specification 5mg/ tablet. Administration method: Oral, 30mg/ time, twice a week; Endocrine drugs: (TAM, AI, fluvestran, etc.) According to patients' previous endocrine treatment, different endocrine drugs were selected according to researchers' judgment, and the dosage was used according to the instructions; OFS drugs (for premenopausal patients only).
Arm Title
Late-stage first-line ± endocrine therapy with CDK4/6 inhibitors in cohort B
Arm Type
Experimental
Arm Description
Chidamide tablets, specification 5mg/ tablet. Administration method: Oral, 30mg/ time, twice a week; Endocrine drugs: (TAM, AI, fluvestran, etc.) According to patients' previous endocrine treatment, different endocrine drugs were selected according to researchers' judgment, and the dosage was used according to the instructions; OFS drugs (for premenopausal patients only).
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
exemestane, Fulvestrant, Letrozole, Anastrozole, Tamoxifen
Intervention Description
Chidamide+ exemestane/Fulvestrant/Letrozole/Anastrozole/Tamoxifen
Primary Outcome Measure Information:
Title
Progression-free survival
Description
PFS is defined as the time from the date of treatment to the first date of disease
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Objective response rate
Description
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)
Time Frame
2 year
Title
Disease control rate
Description
his means that in all patients with a tumor who receive a certain treatment, the tumor shrinks or stays stable, and stays that way for a certain amount of time
Time Frame
2 year
Title
Clinical Benefit Rate (CBR)
Description
CBR is defined as the rate of patients who achieved complete response, partial response, and stable disease for >= 24 weeks as the best response of treatment.
Time Frame
2 year
Title
Overall Survival (OS)
Description
OS defined as the time from the first study treatment administration to death from any cause
Time Frame
2 year
Title
Adverse events (AE)
Description
The level of the adverse event (AE) is analyzed according to the Common Terminology Criteria for Adverse Event (CTCAE) (version 5.0).
Time Frame
2 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal/premenopausal women aged ≥18 years and ≤70 years; HR + / HER2 breast cancer confirmed by histology (note: her2-negative is defined as: (1) IHC1 + / IHC0; ②IHC2+ : FISH-); Confirmed by the histology of locally advanced breast cancer (local treatment) to radical or recurrent metastatic breast cancer; In the late stage of untreated or experienced a CDK4/6 with endocrine therapy of patients; Researchers think that for selecting patients with chemotherapy (step 2022 guidelines recommend for internal transfer, always endocrine therapy resistance or preferred to rescue patients with endocrine therapy best choice of chemotherapy); One line finish cycle disease after chemotherapy (4 to 8 cycles) to alleviate or stable, quasi follow-up maintenance treatment: a. late stage A gleam of unused CDK4/6 inhibitors + endocrine group subjects into the queue for A; b. Used in the late phase line CDK4/6 inhibitors queue B + endocrine subjects into groups; Into the former group at least one measurable lesions (RECIST v1.1 standard); 8.ECOG score 0 to 2 points; 9.Always all the acute toxic reaction caused by antineoplastic therapy in screening before easing to 0 and 1 level (according to the NCI CTCAE 5.0 judgment; Hair loss, other than toxicity that the investigator believes does not pose a safety risk to the subject); 10. Functions: bone marrow neutrophils absolute acuity 1.5 x 109 / L, platelet acuity 100 x 109 / L, 90 g/L or higher hemoglobin; 11. Liver and kidney function: TBIL acuities were 1.5 x ULN; ALT and AST≤2.5 x ULN; In case of liver metastasis, ALT and AST≤ 5×ULN; BUN and Cr≤1.5×ULN and creatinine clearance ≥50 ml/min; 12.Voluntary participation in the clinical trials, signed written informed consent. Exclusion Criteria: Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; Always received HDACi anti-tumor treatment; This scheme known drug components have allergy history; Always with other malignant tumours within five years, not including has cured thyroid papillary carcinoma, cervical carcinoma in situ, basal cell carcinoma or skin squamous cell carcinoma of the skin; Within 4 weeks before into the group participated in other clinical trials; A history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation; Unable to control the important cardiovascular disease: a history of clinical significance of long QT, stage or screen between QTc > 450 ms; Severe cardiovascular injury (greater than a New York Heart Association (NYHA) Class II history of congestive heart failure), unstable angina or myocardial infarction within the last 6 months, or severe arrhythmia; Pregnancy and lactation women patients or in infertile women baseline pregnancy test positive; Or participants of childbearing age who were unwilling to use effective contraception during the study period and for at least 8 weeks after the last dosing; According to the researcher's judgment, there is serious to endanger the safety of patients, the patients completed studies or associated with disease (such as severe hypertension, diabetes, thyroid disease, active infection, etc.); Always have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, etc.; Reference: subjects had active hepatitis (hepatitis b positive HBsAg and HBV DNA of 500 IU/ml or more; Hepatitis C reference: HCV antibody positive and HCV virus copy number > upper limit of normal); The researchers determine doesn't fit to the researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhang
Phone
13920003358
Email
doctor3399@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang
Organizational Affiliation
Tianjin Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
天津市肿瘤医院
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang
Phone
13920003358
Email
doctor3399@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer After First-line Chemotherapy

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