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Breast CancerPhase 2NCT05400993

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

A Phase 2 study testing Chidamide in people with Breast Cancer, run by Shengjing Hospital at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Chidamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
7 sitesChina
Study dates
23 May 2022to 23 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • -
  • 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;
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  • 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.

Trial locations and contacts

7 sites in 1 country.

Caigang Liu, doctoral contact

18940264967

liucg@sj-hospital.org

7 sites in 1 country

China7 sites, 7 recruiting

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

    Benxi, Liaoning

    Honglu Li, professor

    Recruiting

  • Bethune First Hospital of Jilin University

    Changchun, Jilin

    Dong Song, professor

    Recruiting

  • Affiliated Zhongshan Hospital Dalian University

    Dalian, Liaoning

    Dianlong Zhang, professor

    Recruiting

  • Cancer Hospital affiliated to Harbin Medical University

    Haerbin, Heilongjiang

    Zhigao Li, professor

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Cai-Gang Liu, PHD, +86 18940254967, liucg@sj-hospital.org

    Cai-Gang Liu, PHD

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

    Hong Xu, Professor

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

    Xinyu Zheng, professor

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Single-arm Prospective Phase II Study of Chidamide in Combination With Chemotherapy for Neoadjuvant Treatment of HR-positive/HER2-negative Breast Cancer

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.

Read the detailed description

A total of 59 patients with stage Ii-III HR + / HER2 - breast cancer were enrolled in a multi-center, single-arm prospective design. The main purpose of the study was to observe the efficacy and safety of chidamide combined with chemotherapy in neoadjuvant treatment of stage II-III HR + / HER2 - breast cancer Breast MRI and other imaging examinations were reviewed every 2 cycles to evaluate the efficacy. If the efficacy was accurate, surgical treatment was performed within 4 weeks after the 8th cycle of neoadjuvant therapy. If the efficacy was SD+/PD, the study would be withdrawn Within 4 weeks after surgical treatment, the resected tumor tissue and lymph nodes were histopathologically examined (including the pathology of the tumor resection margin). The pathological sections were uniformly lent to the master research unit for unified review

Conditions
Breast Cancer
Being tested
Chidamide
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChidamideCombination product

    Also called pharmorubicin, Cyclophosphamide, Docetaxel

    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。

Study groups in NCT05400993
Study groupRoleWhat they receive
treatment groupExperimentalChidamide 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
Receives: Combination Product: Chidamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RCB 0-1 points ratio

    Residual tumor burden

    Measured: One month after surgery

Secondary outcomes (4)

  1. pCR（ypT0/is、ypN0）

    There was no residual tumor

    Measured: One month after surgery

  2. bpCR（ypT0/is）

    Breast pCRwith ypT0/is carcinoma in situ

    Measured: One month after surgery

  3. ORR

    Proportion of patients who had a 30% reduction in tumor volume and maintained it for more than four weeks

    Measured: Period of neoadjuvant therapy (treatment 1-6 months)

  4. Breast retention rate

    Percentage of patients with successful breast preservation

    Measured: One month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start23 May 2022
  3. Primary completion23 May 2023 (estimated)
  4. Study completion23 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05400993
Sponsor's protocol ID
CSIIT-C25
Status last verified
Jun 2022
First submitted
27 May 2022
Last updated
6 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41080407

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide in people with Breast Cancer, run by Shengjing Hospital at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Caigang Liu, doctoral (18940264967, liucg@sj-hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RCB 0-1 points ratio (time frame: One month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05400993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.

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