Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer

NCT ID: NCT05253066

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-25
• Study Completion Date: 2025-01-31

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide group

Chidamide combined with exemestane (+/- goserelin)

Group Type: EXPERIMENTAL

Chidamide combined with exemestane (+/- goserelin)

Intervention Type: DRUG

Chidamide combined with exemestane (+/- goserelin)

chemotherapy group

Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

Group Type: ACTIVE_COMPARATOR

Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

Intervention Type: DRUG

Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

Interventions

Chidamide combined with exemestane (+/- goserelin)

Chidamide combined with exemestane (+/- goserelin)

Intervention Type: DRUG

Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

Intervention Type: DRUG

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:

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caigang Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MUKDEN5

Identifier Type: -

Identifier Source: org_study_id