Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
Primary Purpose
Breast Neoplasms
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chidamide combined with exemestane (+/- goserelin)
Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
female patients aged greater than or equal to 18 years and less than or equal to 75 years, meet one of the following:
- previous oophorectomy, or age ≥ 60 years;
- age < 60 years, natural postmenopausal status (defined as at least 12 consecutive months of spontaneous cessation of regular menstruation, and no other pathological or physiological causes), E2 and FSH in postmenopausal levels;
- premenopausal or perimenopausal female patients, must be willing to receive LHRH agonist therapy during the study;
- all patients were confirmed by histopathology as estrogen receptor (ER) positive (> 10%), HER2 receptor negative.Follow the 2018 version of ASCO-CAP HER2-negative interpretation guideline criteria;
- tumor stage II-III meeting the AJCC 8th version criteria, patients who have previously received 2 cycles of TE regimen chemotherapy, with disease evaluation of SD or PD;
- KPS score ≥ 70 points;
organ function level must meet the following requirements:
- bone marrow function ANC ≥ 1.5 × 109/L (14 without growth factors); PLT ≥ 100 × 109/L (7 without corrective treatment); Hb ≥ 100 g/L (7) without corrective treatment;
- liver and kidney function TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
- able to undergo needle biopsy;
- voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up
Exclusion Criteria:
- received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- received any other anti-tumor therapy at the same time;
- breast cancer, inflammatory breast cancer or occult breast cancer;
- stage IV breast cancer;
- breast cancer without histopathological diagnosis;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chidamide group
chemotherapy group
Arm Description
Chidamide combined with exemestane (+/- goserelin)
Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
Outcomes
Primary Outcome Measures
ORR
Secondary Outcome Measures
pCR:Upon completion of neoadjuvant therapy and surgery, there was no residual invasive carcinoma present in the pathologic assessment of the resected breast cancer samples stained with hematoxylin and eosin and all ipsilateral lymph node samples.
Residual tumor burden (RCB) classification
Total breast pathological complete remission rate (bpCR)
PEPI classification
Breast-conserving rate
patient-reported outcome(PRO):evaluate daily functioning and health outcomes from the patient's perspective by HRQOL
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related serious adverse event as assessed by CTCAE v5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05253066
Brief Title
Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
Official Title
An Open, Multicenter, Randomized Controlled Clinical Study of Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 25, 2022 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is an open, multicenter, randomized controlled clinical study aimed to explore the efficacy and safety of chidamide combined with exemestane (+/- goserelin) versus chemotherapy in the neoadjuvant treatment of stage II-III HR +/HER2- breast cancer patients with poor response to previous chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chidamide group
Arm Type
Experimental
Arm Description
Chidamide combined with exemestane (+/- goserelin)
Arm Title
chemotherapy group
Arm Type
Active Comparator
Arm Description
Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
Intervention Type
Drug
Intervention Name(s)
Chidamide combined with exemestane (+/- goserelin)
Intervention Description
Chidamide combined with exemestane (+/- goserelin)
Intervention Type
Drug
Intervention Name(s)
Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
Intervention Description
Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
Primary Outcome Measure Information:
Title
ORR
Time Frame
Up to approximately 48 months
Secondary Outcome Measure Information:
Title
pCR:Upon completion of neoadjuvant therapy and surgery, there was no residual invasive carcinoma present in the pathologic assessment of the resected breast cancer samples stained with hematoxylin and eosin and all ipsilateral lymph node samples.
Time Frame
Up to approximately 48 months
Title
Residual tumor burden (RCB) classification
Time Frame
Up to approximately 48 months
Title
Total breast pathological complete remission rate (bpCR)
Time Frame
Up to approximately 48 months
Title
PEPI classification
Time Frame
Up to approximately 48 months
Title
Breast-conserving rate
Time Frame
Up to approximately 48 months
Title
patient-reported outcome(PRO):evaluate daily functioning and health outcomes from the patient's perspective by HRQOL
Time Frame
Up to approximately 48 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
Up to approximately 48 months
Title
Number of participants with treatment-related serious adverse event as assessed by CTCAE v5.0
Time Frame
Up to approximately 48 months
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:
female patients aged greater than or equal to 18 years and less than or equal to 75 years, meet one of the following:
previous oophorectomy, or age ≥ 60 years;
age < 60 years, natural postmenopausal status (defined as at least 12 consecutive months of spontaneous cessation of regular menstruation, and no other pathological or physiological causes), E2 and FSH in postmenopausal levels;
premenopausal or perimenopausal female patients, must be willing to receive LHRH agonist therapy during the study;
all patients were confirmed by histopathology as estrogen receptor (ER) positive (> 10%), HER2 receptor negative.Follow the 2018 version of ASCO-CAP HER2-negative interpretation guideline criteria;
tumor stage II-III meeting the AJCC 8th version criteria, patients who have previously received 2 cycles of TE regimen chemotherapy, with disease evaluation of SD or PD;
KPS score ≥ 70 points;
organ function level must meet the following requirements:
bone marrow function ANC ≥ 1.5 × 109/L (14 without growth factors); PLT ≥ 100 × 109/L (7 without corrective treatment); Hb ≥ 100 g/L (7) without corrective treatment;
liver and kidney function TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
able to undergo needle biopsy;
voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up
Exclusion Criteria:
received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
received any other anti-tumor therapy at the same time;
breast cancer, inflammatory breast cancer or occult breast cancer;
stage IV breast cancer;
breast cancer without histopathological diagnosis;
12. IPD Sharing Statement
Learn more about this trial
Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
We'll reach out to this number within 24 hrs