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

Phase 2

Not yet recruiting

• Conditions: Breast Neoplasms
• Interventions: Drug: Chidamide combined with exemestane (+/- goserelin); Drug: Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

• Registration Number: NCT05253066
• Lead Sponsor: Shengjing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-13
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-15
• Last Update Submitted: 2022-02-15
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23
• Study Start: 2022-02-25
• Primary Completion: 2022-07-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 130

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

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chidamide group	Chidamide combined with exemestane (+/- goserelin)	Chidamide combined with exemestane (+/- goserelin)
chemotherapy group	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)

Primary Outcome Measures

Name	Time	Method
ORR	Up to approximately 48 months

Secondary Outcome Measures

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