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Breast CancerPhase 2NCT05749575

Chidamide Plus PD-1 Plus Paclitaxel of Neoadjuvant Treatment in Low HR Expression,HER2-negative Early Breast Cancer.

A Phase 2 study testing Chidamide Plus Toripalimab Plus Paclitaxel in people with Breast Cancer, run by Sun Yat-sen University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Triple-negative breast cancer has always been a difficult problem in clinical practice because of its young onset age, high aggressiveness, no clear therapeutic target and poor clinical prognosis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer
What is being tested?
Chidamide Plus Toripalimab Plus Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
Feb 2023to Aug 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.18-75 years old. 2.ECOG whole-body status (performance status , PS) grade 0 to 1. 3.ER and PR IHC showed <10% staining and HER2 negative. 4.The patients who receive at least 2 neoadjuvant sessions with anthracycline are assessed to SD (4 anthracycline-containing sessions) or PD with breast MRI, CT or ultrasound according to the RECIST standard.
  • 5.The patients refuse prior surgical treatment (the patient requires breast preservation, but it cannot be performed by surgical consultation), or it is not suitable for prior surgical treatment.
  • 6.The main organ function is normal, that is, to meet the following criteria:
  • the criteria for blood routine examination:
  • ANC≥1.5×109/L；
  • PLT≥100×109/L；
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  • Hb≥90g/L；
  • the criteria for biochemical examination:
  • TBIL<1.5×ULN；
  • ALT and AST<2.5×ULN；
  • BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault formula).
  • 7.No malabsorption or other gastrointestinal disorders that affect drug absorption 8.Serum pregnancy tests for women of childbearing age must be negative within 7 days before treatment; all enrolled patients (whether male or female) should have adequate barrier contraception throughout the treatment period and within 4 weeks of treatment.
  • 9.The subjects volunteer to join the study and sign informed consent, with good compliance and cooperated with follow-up.

Who cannot join

  • Previous use of investigational drugs such as PD-1 or PD-L1 mAb; sidabamine or other HDAC inhibitors, and taxane-based chemotherapies (including paclitaxel or docetaxel).
  • Distant metastases, but enrollment could be considered if the distant metastatic lesion is confined to the ipsilateral cervical lymph exclusion criteria node only.
  • Unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina pectoris, congestive heart failure, hepatic, renal, or metabolic disease, etc).
  • Any other malignancy within five years (except completely cured cervical carcinoma in situ or basal or squamous epithelial skin carcinoma).
  • For known human immunodeficiency virus (HIV) infection, hepatitis B virus carriers must be treated for anti-hepatitis B virus replication during antitumor therapy.
  • Prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.
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  • Pregnant or lactating women.
  • Any unstable or potentially jeopardizing patient safety and its compliance to the study.
  • Other situations that investigators think it is unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country.

Fei Xu, MD contact

+86-13711277870

xufei@sysucc.org.cn

Kuikui Jiang, MD contact

+86-15210589011

jiangkk@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Fei Xu, MD, +86-13711277870, xufei@sysucc.org.cn

    Fei Xu, MD

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Open-label, Phase II Clinical Trial of Chidamide, PD-1 Monoclonal Antibody and Paclitaxel in Neoadjuvant Therapy for Low Hormone Receptor(HR) Expression,HER2-negative Early Breast Cancer.

Triple-negative breast cancer has always been a difficult problem in clinical practice because of its young onset age, high aggressiveness, no clear therapeutic target and poor clinical prognosis. The treatment of triple-negative breast cancer is mainly chemotherapy, and in order to break the current dilemma, new treatments must be introduced. Immunotherapy is one of the most high-profile treatments. The KEYNOTE-522 study and Impassion 031 Study have found that immunotherapy can significantly improve the pCR of patients with triple yin breast cancer, rate, independent of PD-L1 expression status, and good safety.Cedardenamine is a histone deacetylation (HDAC) inhibitor developed in China.Many studies suggest that the use of sidabamine will likely enhance the efficacy of PD-1 / PD-L1 mAb in breast cancer and expand the use of PD-1 / PD-L1 mAb in the beneficiary population of breast cancer

Read the detailed description

Cedaramine can effectively inhibit subtypes 1,2,3 of HDAC class I and type 10 of class IIb. Sidabamide can directly induce cycle arrest and apoptosis in tumors and has demonstrated its clinical role in lymphoma and breast cancer.besides, In recent years, many studies have found that HDAC inhibitors also have their functions in regulating immunity, Such as: 1) upregulated tumor antigen / co-stimulatory molecule / receptor levels of tumor cells (such as MHC I / II, PRAME, MIC A/B, PDL-1, etc.), Make it easier to be recognized by the immune system; 2) Initialize the natural immune system, Activating NK cell activity; 3) Initialize the acquired immune system, Activating initial T cells (Naive T cells) to target tumor antigen; 4) Increase the CD8 + effector cells that kill tumor cells, Downregulation of the immunosuppressive cells, Such as the Treg 6 7 and MDSC, Promote the formation and maintenance of acquired immune memory T cells. Preclinical studies suggested that HDAC was synergistic with PD-1 / PD-L1 antibodies and could serve as a sensitizer for PD-1 / PD-L1 antibodies. A phase I study in solid tumors found that sitabenamine combined with natureumab had an objective response rate (ORR) of 48% and a disease control rate (DCR) of 87%.Therefore, we conduct this study to observe the efficacy and safety of neoadjuvant therapy in early HR low-expression ,HER2-negative breast cancer patients treated with PD-1 mAb and paclitaxel.

Conditions
Breast Cancer
Being tested
Chidamide Plus Toripalimab Plus Paclitaxel
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Chidamide Plus Toripalimab Plus PaclitaxelDrug

    Each participant receives chidamide plus toripalimab plus paclitaxel

Study groups in NCT05749575
Study groupRoleWhat they receive
Chidamide Plus Toripalimab Plus PaclitaxelExperimentalCedaramine: 20mg, twice a week.Toripalimab: 240mg, once in 3 weeks,intravenous.Paclitaxel: 175mg / m2, once in 3 weeks, routine preventive anti-allergy treatment, surgery after 4 cycles of IV infusion.
Receives: Drug: Chidamide Plus Toripalimab Plus Paclitaxel

What is being measured

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

  1. Pathology tpCR (ypT0/is, ypN0) rate

    After completion of neoadjuvant therapy and surgery, there was no residual invasive carcinoma in the pathological evaluation of hematoxylin-and eosin-stained resected breast cancer samples and all ipsilateral lymph node samples. Count pCR rate in patients undergoing surgery.

    Measured: 1 year

Secondary outcomes (4)

  1. Objective response rate (ORR)

    The proportion of subjects who achieved CR or PR as optimal tumor response in the ITT population, as assessed by the efficacy evaluation criteria for solid tumors (RECIST1.1).

    Measured: 1 year

  2. Disease-free survival (DFS)

    Defined as the time interval from the first day of no disease (the date of surgery) to the first recording of a related event, including postoperative disease recurrence or metastasis and death from any cause.

    Measured: 1 year

  3. Disease-free survival in 3 years

    Defined as disease-free survival for all patients undergoing surgery from the first day of no disease ( the date of surgery) to 3 years.

    Measured: 3 year

  4. Event-free survival (EFS)

    Defined as the time interval from the first day of no disease (the date of surgery) to the first recording of related events, including postoperative disease recurrence or metastasis.

    Measured: 1 year

Timeline

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

  1. First posted1 Mar 2023
  2. Study startFeb 2023 (estimated)
  3. Primary completionAug 2023 (estimated)
  4. Study completionAug 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
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05749575
Sponsor's protocol ID
SYSU-2022-02
Status last verified
Feb 2023
First submitted
19 Feb 2023
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide Plus Toripalimab Plus Paclitaxel in people with Breast Cancer, run by Sun Yat-sen University at 1 site 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 13 inclusion and 9 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Fei Xu, MD (+86-13711277870, xufei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathology tpCR (ypT0/is, ypN0) rate (time frame: 1 year). 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 NCT05749575.

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 1 Mar 2023.

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