Back to results

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)

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

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

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:
1. previous oophorectomy, or age ≥ 60 years;
2. 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;
3. 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:
1. 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;
2. 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

NCT ID

NCT05253066

First Posted

January 13, 2022

Last Updated

February 15, 2022

Sponsor

Shengjing Hospital

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

Studies a U.S. FDA-regulated Device Product

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

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

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