To hear about similar clinical trials, please enter your email below
Trial Title:
Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Previous CDK4/6 i Adjuvant Therapy
NCT ID:
NCT05806047
Condition:
Hormone Receptor-positive Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Fulvestrant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
chidamide combined with fulvestrant
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
chidamide combined with fulvestrant
Description:
chidamide combined with fulvestrant
Arm group label:
chidamide combined with fulvestrant
Summary:
This trial is a single-arm study. The purpose of the trial is to evaluate the efficacy
and safety of chidamide and fulvestrant in HR+/HER2- breast cancer that has failed prior
adjuvant endocrine therapy with CDK4/6 inhibitors.
Detailed description:
The study was a single-center, single-arm, open trial design. Twenty-three patients with
advanced HR+/HER2- breast cancer who had failed previous adjuvant treatment with CDK4/6
inhibitors in combination with endocrine therapy were treated with fulvestrant and
chidamide.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female, ≥18 years old;
2. ECOG score 0-1;
3. Predicted survival ≥3 months;
4. Patients with locally advanced and/or metastatic breast cancer confirmed by
histopathology with positive ER expression and negative ER2 expression;
5. Patients who have relapsed or metastasized during or after CDK4/6 inhibitors
combined with endocrine adjuvant therapy and have not received systemic antitumor
therapy for the current stage of disease;
6. No previous treatment with fluvestran or use of fluvestran without proven treatment
failure;
7. The time interval between non-endocrine therapy should be ≥2 weeks;
8. At least one extracranial measurable lesion as defined by RECIST V1.1 criteria;
9. The functions of vital organs meet the requirements;
10. Fertile subjects must have a negative pregnancy test 7 days before starting
treatment and must use an appropriate contraceptive method during treatment and for
three months after completion of treatment;
11. The patient is fully informed and voluntarily signs the informed consent.
Exclusion Criteria:
1. Prior treatment with any HDAC inhibitors;
2. Known allergy to the tested drug component;
3. inflammatory breast cancer at the time of screening;
4. pia meningeal metastasis confirmed by MRI or lumbar puncture;
5. Central nervous system metastasis confirmed by imaging;
6. To the best of the investigator's judgment, symptomatic visceral disease or any
disease load or none is considered optimal Endocrine therapy options are not
suitable for endocrine therapy;
7. Inability or unwillingness to swallow medication or receive intramuscular
injections;
8. Gastrointestinal insufficiency or gastrointestinal disease (if not controlled) that
may significantly affect study drug absorption Ulcerative disease, uncontrolled
nausea, vomiting, diarrhea, malabsorption syndrome or small intestine resection,
etc.;
9. Patients with ascites, pleural effusion and pericardial effusion accompanied by
clinical symptoms in the baseline period need drainage, or use it for the first time
Patients with serous cavity drainage within 4 weeks before medication;
10. A history of immunodeficiency, including HIV positive, or other acquired or
congenital immunodeficiency conditions, Or have a history of organ transplantation;
11. Other malignancies (cured basal cell carcinoma of the skin, carcinoma in situ of the
cervix, and Thyroid cancer is excluded);
12. had undergone major surgical procedures or significant trauma within 4 weeks prior
to the start of treatment, or was expected to undergo major surgery Surgical
treatment;
13. Concomitant diseases that, in the investigator's judgment, seriously endanger
patient safety or interfere with patient completion of the study (e.g.
Severe hypertension, diabetes, thyroid disease, co-active hepatitis B/C, and other
activities Sexual infection);
14. Inability to understand or follow research instructions and requirements;
15. The researcher decides that it is not suitable to participate in this study
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 1, 2023
Completion date:
November 1, 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05806047
