Clinical Study of Chidamide Combined With Chemotherapy in Neoadjuvant Treatment of HR+/ HER2-BC

NCT05400993 | Unknown Phase 2

• 1 other identifier: CSIIT-C25
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 7

Brief Summary

Neoadjuvant therapy for HR+/HER2- breast cancer is dominated by anthracycline combined with paclitaxel chemotherapy. Aggressive neoadjuvant chemotherapy can only achieve pCR in about 10% of PATIENTS with HR-positive breast cancer. The emergence of new targeted drugs brings new life and hope to HR-positive breast cancer patients.Basic studies have shown that the abnormal state of epigenetics is associated with the metastasis of drug resistance and recurrence of tumor histone deacetylase (HDAC) is an important regulator of epigenetic regulation, and drugs targeting HDAC provide a new strategy for tumor therapy. The ACE study suggests that selective HDAC inhibitor chidamide in combination with endocrine therapy significantly improves survival benefit in patients with hr-positive HER2-negative advanced breast cancer who relapsed or progressed after endocrine therapy, providing a new treatment option for these patients.In conclusion, we hypothesize that neoadjuvant therapy with chidamide combination therapy provides a better strategy for patients with HR + /HER2 - breast adenocarcinoma.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• RCB 0-1 points ratio

  Residual tumor burden

  One month after surgery

Secondary Outcomes (4)

• pCR（ypT0/is、ypN0）

  One month after surgery

• bpCR（ypT0/is）

  One month after surgery

• ORR

  Period of neoadjuvant therapy (treatment 1-6 months)

• Breast retention rate

  One month after surgery

Other Outcomes (1)

• Adverse Events (AE) and Serious Adverse Events (SAE)

  Period of neoadjuvant therapy (treatment 1-6 months)And chidamide 3 weeks after withdrawal

Study Arms (1)

treatment group

EXPERIMENTAL

Chidamide combined with EC -- T regimen was treated with 1 cycle every 21 days, followed by 4 cycles of EC followed by 4 cycles of T, a total of 8 cycles

Combination Product: Chidamide

Interventions

Chidamide COMBINATION_PRODUCT

Chidamide: take orally twice a week,4 tablets/time (20mg/ time), the interval between two doses should not be less than 3 days (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), the day before chemotherapy, 30 minutes after breakfast； Chidamide: 20mg, orally, twice a week, oral for two weeks and one week, a total of 8 cycles； Epirubicin 90mg/m2 , ivgtt, d1 Cyclophosphamide 600mg/m 2, ivgtt, d1 Q3w, 4 cycle； sequential Docetaxel 100 mg/m 2, IVGtt, D1 Q3w, 4 cycle。

Also known as: pharmorubicin, Cyclophosphamide, Docetaxel

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or older and 75 years or younger;
• All patients were histopathologically confirmed to be estrogen receptor (ER) positive (\& GT; 10%),HER2 receptor negative follows the 2018 ASCO-CAP HER2 negative interpretation guideline criteria;
• Newly treated patients with stage II-III tumor staging meeting AJCC Version 8 criteria;
• KPS score ≥70;
• The functional level of the organ must meet the following requirements:
• Bone marrow function
• ANC ≥ 1.5×10 9 /L (growth factor not used within 14 days);
• PLT ≥ 100×10 9 /L (no corrective treatment within 7 days);
• Hb ≥ 100 g/L (no corrective treatment within 7 days);
• Liver and kidney function
• TBIL ≤1.5 x 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;
• Volunteered to participate in the study, signed informed consent, had good compliance and was willing to cooperate with follow-up.

You may not qualify if:

• Participants are not allowed to participate in the clinical study under any of the following conditions:
• Have received any other form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
• Receiving any other antitumor therapy;
• Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer;
• Stage IV breast cancer;
• Breast cancer without histopathological diagnosis;
• Other malignant tumors within the past 5 years, except cured carcinoma in situ of the cervix;
• Severe heart, liver, kidney and other important organ dysfunction;
• Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug taking and absorption;
• Participated in clinical trials of other drugs within 4 weeks before enrollment;
• Known history of allergy to the drug components of this regimen; History of immunodeficiency, including HIV positive, HCV, live active hepatitis B or other acquired or congenital immune deficiency diseases, or a history of organ transplantation;
• History of any heart disease, including :(1) medically required or clinically significant arrhythmia; (2) myocardium infarction; (3) heart failure; (4) Any other heart disease deemed unsuitable for the study by the investigator;
• Pregnant, lactating women, fertile women with positive baseline pregnancy test or in the entire women of reproductive age who were unwilling to use effective contraception during the trial;
• According to the investigator's judgment, there are comorbidities (including but) that seriously endanger the patient's safety or affect the patient's ability to complete the study not limited to severe hypertension, severe diabetes, active infection, etc., which cannot be controlled by drugs);
• A clear past history of neurological or psychiatric disorders, including epilepsy or dementia. The investigator considered the patient unsuitable for the study in any other case.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (7)

Cancer Hospital affiliated to Harbin Medical University

Haerbin, Heilongjiang, China

RECRUITING

Bethune First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Health Science and Technology Information Center of Liaoning Health Industry Group Co., LTD

Benxi, Liaoning, China

RECRUITING

Affiliated Zhongshan Hospital Dalian University

Dalian, Liaoning, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Related Publications (1)

• Xue J, Shan H, Qiu F, Niu N, Chen G, Xu Q, Gu X, Xing F, Xu Y, Zheng X, He G, Xu H, Zhang H, Song D, Han Y, Tang M, Cao S, Song Y, Zheng R, Zhao Y, Jiao G, Liu M, Liu C. Neoadjuvant chidamide combined with chemotherapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (MUKDEN 05): a multicentre, single-arm, phase 2 trial. Lancet Reg Health West Pac. 2025 Sep 27;63:101700. doi: 10.1016/j.lanwpc.2025.101700. eCollection 2025 Oct.

  PMID: 41080407 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Epirubicin; Cyclophosphamide; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Caigang Liu, doctoral

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caigang Liu, doctoral

CONTACT

18940264967; liucg@sj-hospital.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral 、chief physician

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Study Start: May 23, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2024
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

CN (7)