Combining Chidamide with Endocrine Therapy for Advanced Breast Cancer Maintenance

An Open, Single-center, Exploratory Cohort Study of Chidamide in Combination With Endocrine in Maintenance Therapy After First-line Chemotherapy for HR+/HER2- Breast Cancer

This study is testing if adding Chidamide to hormone therapy can help women with advanced breast cancer who haven't responded well to previous treatments feel better and improve their outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin)
• Trial ID: NCT05890287 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of Chidamide in combination with endocrine therapy as a maintenance treatment for women with HR+/HER2- advanced breast cancer following first-line chemotherapy. The trial aims to evaluate how this combination can help patients who have either not responded to or have progressed after treatment with CDK4/6 inhibitors. Participants will be monitored for treatment outcomes and side effects to determine the potential benefits of this new therapeutic approach.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal or premenopausal women aged 18 to 70 with HR+/HER2- breast cancer who have completed first-line chemotherapy.

Not a fit: Patients with HER2 positive breast cancer or those who have not undergone first-line chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new maintenance therapy option for patients with advanced breast cancer, potentially improving their outcomes and quality of life.

How similar studies have performed: While the combination of Chidamide with endocrine therapy is a novel approach, similar studies have shown promise in targeting HR+/HER2- breast cancer with alternative therapies.

Eligibility criteria

Inclusion Criteria:

1. Postmenopausal/premenopausal women aged ≥18 years and ≤70 years;
2. HR + / HER2 breast cancer confirmed by histology (note: her2-negative is defined as: (1) IHC1 + / IHC0; ②IHC2+ : FISH-);
3. Confirmed by the histology of locally advanced breast cancer (local treatment) to radical or recurrent metastatic breast cancer;
4. In the late stage of untreated or experienced a CDK4/6 with endocrine therapy of patients;
5. 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 choice of chemotherapy);
6. 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 subjects into the queue for A; b. Used in the late phase line CDK4/6 inhibitors queue B + endocrine subjects into groups;
7. 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 level (according to the NCI CTCAE 5.0 judgment; Hair loss, other than toxicity that the investigator believes does not pose a safety risk to the subject); 10. Functions: bone marrow neutrophils absolute acuity 1.5 x 109 / L, platelet acuity 100 x 109 / L, 90 g/L or higher hemoglobin; 11. Liver and kidney function: TBIL acuities were 1.5 x ULN; ALT and AST≤2.5 x ULN; In case of liver metastasis, ALT and AST≤ 5×ULN; BUN and Cr≤1.5×ULN and creatinine clearance ≥50 ml/min; 12.Voluntary participation in the clinical trials, signed written informed consent.

Exclusion Criteria:

1. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
2. Always received HDACi anti-tumor treatment;
3. This scheme known drug components have allergy history;
4. 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;
5. Within 4 weeks before into the group participated in other clinical trials;
6. A history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation;
7. 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 (NYHA) Class II history of congestive heart failure), unstable angina or myocardial infarction within the last 6 months, or severe arrhythmia;
8. 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 least 8 weeks after the last dosing;
9. 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 infection, etc.);
10. Always have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, etc.;
11. Reference: subjects 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);
12. The researchers determine doesn't fit to the researchers.

Where this trial is running

Tianjin

• 天津市肿瘤医院 — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Li Zhang — Tianjin Cancer Hospital
• Study coordinator: Li Zhang

Conditions HR Positive HER2 Negative Advanced Breast Cancer