Clinical Study of Chidamide Combined With Fulvestrant in the Treatment of Hormone Receptor-positive Advanced Breast Cancer

This is a Open-label study of chidamide in combination with fulvestrant for the treatment of postmenopausal women with hormone receptor positive, Her2 negative, advanced breast cancer who have received no or only one line of endocrine therapy for advanced breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: Chidamide; Drug: Fulvestrant

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sun Tao, Doctor; Phone Number: 13940404526; Email: lnzlrxnsy@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liangning Tumor Hospital &Institute
      • Contact: Sun Tao, Doctor; Phone Number: 13940404526; Email: lnzlrxnsy@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. women aged ≥ 18 years, histologically or cytologically confirmed HR positive (ER expression ≥ 10%, PR positive or negative), HER2 negative breast cancer patients;
2. before enrollment for unresectable locally advanced or metastatic breast cancer, and at least one measurable lesion or no measurable lesion and bone metastasis alone patients;

3. For locally advanced or metastatic breast cancer, no previous endocrine therapy or first-line endocrine therapy, and no previous use of CDK4/6 inhibitors. Specifically, it includes the following conditions:

   Cohort 1: (neo) recurrence > 12 months after the end of adjuvant endocrine therapy, and without any rescue therapy · newly diagnosed advanced breast cancer without any rescue therapy Cohort 2: (neo) recurrence during or ≤ 12 months after the completion of adjuvant endocrine therapy, and without any rescue therapy · recurrence > 12 months after the completion of adjuvant endocrine therapy, and progression by first-line endocrine therapy · newly diagnosed advanced breast cancer and progression by first-line endocrine rescue therapy

4. Cohort 1 without previous chemotherapy for advanced breast cancer; Cohort 2 with ≤ 1 previous chemotherapy for advanced breast cancer;
5. no brain metastasis or asymptomatic brain metastasis;
6. ECOG score 0-1;
7. Absolute neutrophil count ≥ 1.5 × 109/L, platelet ≥ 100 × 109/L, hemoglobin ≥ 90 g/L;
8. Expected survival time ≥ 3 months;
9. Voluntarily participate in this clinical trial, sign the written informed consent;

Exclusion Criteria:

1. no measurable lesions (except bone metastases alone), such as pleural or pericardial exudates, ascites, etc.
2. Patients who have undergone major surgical procedures or significant trauma before enrollment, or are expected to undergo major surgical treatment
3. Patients who have previously been treated with CDK4/6 inhibitors, fulvestrant or HDAC inhibitors (including romidepsin, vorinostat, berlistat, parabrestat), but have received 1 cycle (≤ 2 times, on d1, d15, respectively) of fulvestrant within 28 days (before enrollment) are allowed
4. Known history of allergy to the drug components of this protocol
5. Meningeal metastasis before enrollment
6. Uncontrollable serosal effusion
7. Active infection [an active bacterial, viral, fungal, mycobacterial, parasitic or other infection (excluding fungal infections of the nail bed) within 4 months prior to Screening or any major infectious event requiring intravenous antibiotics, or targeted antiviral therapy, or hospitalization], or persistent fever within 14 days prior to Screening
8. a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
9. according to the investigator's judgment, there are serious hazards to the patient's safety, or affect the patient to complete the study of concomitant diseases (such as: severe hypertension, diabetes, thyroid disease, active infection, etc.);
10. History of definite neurological or psychiatric disorders, including epilepsy or dementia
11. Subjects who, in the opinion of the investigator, are not suitable for the 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 + fulvestrant	Drug: Chidamide; chidamide 30mg orally，Biw; Drug: Fulvestrant; Fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.	Up to approximately 26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time from date of randomization to the date of death from any cause.	Up to approximately 58 months
Progression Free Survival (PFS)	PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause.	Up to approximately 26 months
Clinical Benefit Rate (CBR)	Clinical benefit rate (CBR), defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1.	Up to approximately 26 months
Duration of Response (DOR)	Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1.	Up to approximately 26 months

Collaborators and Investigators

• Sponsor: Liaoning Tumor Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Anticipated): June 18, 2022
• Study Completion (Anticipated): September 18, 2023

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

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-C18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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