Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Previous CDK4/6 i Adjuvant Therapy

Phase II Clinical Study of Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Prior Adjuvant Therapy With CDK4/6 Inhibitors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hormone Receptor-positive Advanced Breast Cancer
• Intervention / Treatment: Drug: chidamide combined with fulvestrant

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.

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chidamide combined with fulvestrant	Drug: chidamide combined with fulvestrant; chidamide combined with fulvestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)	max 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBR	The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.	max 6 months
PFS	time to progressive disease (according to RECIST1.1)	Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1 years)
DOR	Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.	max 6 months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant
• Other Study ID Numbers: CSIIT-C41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No