Chidamide Plus PD-1 Plus Paclitaxel of Neoadjuvant Treatment in Low HR Expression,HER2-negative E… (NCT05749575) | Clinical Trial Compass
UnknownPhase 2
Chidamide Plus PD-1 Plus Paclitaxel of Neoadjuvant Treatment in Low HR Expression,HER2-negative Early Breast Cancer.
China28 participantsStarted 2023-02
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.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.
.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；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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.