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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Chidamide combined with exemestane (+/- goserelin); Drug: Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chidamide group; Chidamide combined with exemestane (+/- goserelin)	Drug: Chidamide combined with exemestane (+/- goserelin); Chidamide combined with exemestane (+/- goserelin)
Active Comparator: chemotherapy group; Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ORR	Up to approximately 48 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Up to approximately 48 months
Residual tumor burden (RCB) classification	Up to approximately 48 months
Total breast pathological complete remission rate (bpCR)	Up to approximately 48 months
PEPI classification	Up to approximately 48 months
Breast-conserving rate	Up to approximately 48 months
patient-reported outcome（PRO）：evaluate daily functioning and health outcomes from the patient's perspective by HRQOL	Up to approximately 48 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Up to approximately 48 months
Number of participants with treatment-related serious adverse event as assessed by CTCAE v5.0	Up to approximately 48 months

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 25, 2022
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Docetaxel; Epirubicin; Goserelin; Exemestane
• Other Study ID Numbers: MUKDEN5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No