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

NCT05749575 | Unknown Phase 2

• 1 other identifier: SYSU-2022-02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (4)

• Objective response rate (ORR)

  1 year

• Disease-free survival (DFS)

  1 year

• Disease-free survival in 3 years

  3 year

• Event-free survival (EFS)

  1 year

Study Arms (1)

Chidamide Plus Toripalimab Plus Paclitaxel

EXPERIMENTAL

Cedaramine: 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.

Drug: Chidamide Plus Toripalimab Plus Paclitaxel

Interventions

Chidamide Plus Toripalimab Plus Paclitaxel DRUG

Each participant receives chidamide plus toripalimab plus paclitaxel

Chidamide Plus Toripalimab Plus Paclitaxel

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• 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；
• 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).
• 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.
• The subjects volunteer to join the study and sign informed consent, with good compliance and cooperated with follow-up.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; toripalimab; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Fei Xu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Xu, MD

CONTACT

+86-13711277870; xufei@sysucc.org.cn

Kuikui Jiang, MD

CONTACT

+86-15210589011; jiangkk@sysucc.org.cn

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: Associate Chief Physician

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 1, 2023
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)