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New treatment option for HR Positive HER2 Negative Advanced Breast Cancer
Official title A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer After First-line Chemotherapy
ClinicalTrials.gov ID: NCT05890287
What this study is testing
What is Chidamide?
Chidamide is an investigational medicine, being studied as a potential treatment for hr positive her2 negative advanced breast cancer.
Also referred to as exemestane, Fulvestrant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To explore the efficacy and safety of Chidamide combined with endocrine for maintenance therapy after first-line chemotherapy for HR+/HER2- breast cancer
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Postmenopausal/premenopausal women aged ≥18 years and ≤70 years;
- HR + / HER2 breast cancer confirmed by histology (note: her2-negative is defined as: (1) IHC1 + / IHC0; ②IHC2+ : FISH-);
- Confirmed by the histology of locally advanced breast cancer (local treatment) to radical or recurrent metastatic breast cancer;
- In the late stage of untreated or experienced a CDK4/6 with endocrine therapy of patients;
- Researchers think that for selecting patients with chemotherapy (step 2022 guidelines recommend for internal transfer, always endocrine therapy...
You likely can't join if
- Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Always received HDACi anti-tumor treatment;
- This scheme known drug components have allergy history;
- Always with other malignant tumours within five years, not including has cured thyroid papillary carcinoma, cervical carcinoma in situ, basal cell...
- Within 4 weeks before into the group participated in other clinical trials;
- A history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or has a history of...
See the full eligibility criteria
- Postmenopausal/premenopausal women aged ≥18 years and ≤70 years;
- HR + / HER2 breast cancer confirmed by histology (note: her2-negative is defined as: (1) IHC1 + / IHC0; ②IHC2+ : FISH-);
- Confirmed by the histology of locally advanced breast cancer (local treatment) to radical or recurrent metastatic breast cancer;
- In the late stage of untreated or experienced a CDK4/6 with endocrine therapy of patients;
- Researchers think that for selecting patients with chemotherapy (step 2022 guidelines recommend for internal transfer, always endocrine therapy resistance or preferred to rescue patients with endocrine therapy best...
- One line finish cycle disease after chemotherapy (4 to 8 cycles) to alleviate or stable, quasi follow-up maintenance treatment: a. late stage A gleam of unused CDK4/6 inhibitors + endocrine group people into the queue...
- Into the former group at least one measurable lesions (RECIST v1.1 standard); 8.ECOG score 0 to 2 points; 9.Always all the acute toxic reaction caused by antineoplastic therapy in screening before easing to 0 and 1...
- Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Always received HDACi anti-tumor treatment;
- This scheme known drug components have allergy history;
- Always with other malignant tumours within five years, not including has cured thyroid papillary carcinoma, cervical carcinoma in situ, basal cell carcinoma or skin squamous cell carcinoma of the skin;
- Within 4 weeks before into the group participated in other clinical trials;
- A history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation;
- Unable to control the important cardiovascular disease: a history of clinical significance of long QT, stage or screen between QTc \> 450 ms; Severe cardiovascular injury (greater than a New York Heart Association...
- Pregnancy and lactation women patients or in infertile women baseline pregnancy test positive; Or participants of childbearing age who were unwilling to use effective contraception during the study period and for at...
- According to the researcher's judgment, there is serious to endanger the safety of patients, the patients completed studies or associated with disease (such as severe hypertension, diabetes, thyroid disease, active...
- Always have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, etc.;
- Reference: people had active hepatitis (hepatitis b positive HBsAg and HBV DNA of 500 IU/ml or more; Hepatitis C reference: HCV antibody positive and HCV virus copy number \> upper limit of normal);
- The researchers determine doesn't fit to the researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.