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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05253066
• Other study ID #: MUKDEN5
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: February 25, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2022
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: January 31, 2025
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Chidamide combined with exemestane (+/- goserelin)
Chidamide combined with exemestane (+/- goserelin)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Outcome

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