Tucidinostat and Fulvestrant in Hormone-receptor Positive Advanced Breast Cancer

August 7, 2021 updated by: Anqin Zhang, Guangdong Women and Children Hospital

Trial of Tucidinostat in Combination With Fulvestrant in Patients With Hormone-receptor Positive Advanced Breast Cancer

The purpose of the study is evaluate the efficacy and safety of tucidinostat in combination with fulvestrant in patients with hormone-receptor positive advanced breast cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hormone-receptor positive breast cancer is the most common subtype in breast cancer. Tucidinostat is an oral subtype-selective histone deacetylase inhibitor, which showed preliminary signs of encouraging anti-tumour activity in patients with advanced hormone-receptor positive breast cancer in the previous studies. The aim of this study is to evaluate the efficacy and safety of Tucidinostat in combination with fulvestrant in patients with recurrent or metastatic hormone-receptor positive breast cancer.

Study Type

Interventional

Enrollment (Anticipated)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients aged 18-75 years (including cutoff value);
  2. The disease condition is inoperable, recurrent breast cancer, or metastatic breast cancer;
  3. Histological or cytological confirmation of hormone receptor-positive [estrogen receptor (ER) positive and progesterone receptors (PgR) positive or negative] breast cancer;
  4. At least one measurable lesion according to RECIST 1.1;
  5. Prior treatment: have not received systemic chemotherapy for recurrent or metastatic breast cancer;
  6. Eastern Cooperative Oncology Group Performance Status of 0-1;

  7. Adequate function of major organs meets the following requirements):

    Absolute Neutrophils count≥ 1.5×10^9/L; Platelets count≥ 90×10^9/L; Hemoglobin ≥ 90g/L; Total bilirubin≤ 1.5 × the upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; QTcF(Fridericia correction) ≤ 470 ms; International normalized ratio(INR)≤1.5 × ULN; activated partial thromboplastin time(APTT) ≤ 1.5 × ULN;

  8. Life expectancy ≥ 3 months;
  9. Have signed informed consent.

Exclusion Criteria:

  1. Patients have untreated central nervous system (CNS) metastases;
  2. Patients with no measurable lesion according to RECIST 1.1;
  3. Patients with bilateral breast cancer;
  4. Patients with human epidermal growth factor receptor-2 (Her-2) positive;
  5. Recurrent or metastatic disease occurs within 2 years during adjuvant endocrine therapy;
  6. Patients previously received systemic chemotherapy for recurrent or metastatic breast cancer;
  7. Patients previously received any HDAC inhibitor or fulvestrant treatment;
  8. There are ascites, pleural effusion, pericardial effusion with clinical symptoms at baseline, those who need drainage, or those who have undergone drainage of serous effusion within 4 weeks before the first dose;
  9. Inability to swallow, intestinal obstruction or other factors affecting the administration and absorption of the drug;
  10. Patients with other invasive malignancies within 5 years or at the same time, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ;
  11. Patients with a history of allergies to the drug components of this regimen;
  12. Patients with active HBV and HCV infection; stable hepatitis B after drug treatment (HBV virus copy number is higher than the upper limit of reference value) and cured hepatitis C patients (HCV virus copy number exceeds the lower limit of detection method) can be included;
  13. Patients with a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation;
  14. Patients have uncontrolled or significant cardiovascular disease, including: Myocardial infarction (< the last 12 months); Uncontrolled angina (< the last 6 months); Congestive heart failure (< the last 6 months), or Left Ventricular Ejection Fraction (LVEF) < 50% prior to study entry;
  15. Any mental or cognitive disorder, that would interfere the ability to understand the informed consent document or the operation and compliance of study;
  16. Any other condition which is inappropriate for the study in the opinion of the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tucidinostat + Fulvestrant

Patients receive 30 mg Chidamide twice per week. Fulvestrant 500mg (2 syringes of Fulvestrant 250mg), Fulvestrant 500 mg i.m. every 28 (+/- 3) days plus an additional 500 mg on day 14 (+/-3) of first month only.

Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Tucidinostat
30 mg, administered orally twice per week (BIW)
Drug: Fulvestrant
Fulvestrant was supplied as a castor oil based solution in clear neutral glass pre-filled syringes. Each syringe will contain 250 mg of fulvestrant in 5 ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
PFS was defined as the time from treatment until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), or death by any cause, whichever is first met.
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: Time from treatment to death from any cause, assessed up to 3 years.
Defined as from the date of treatment to date of death, irrespective of cause.
Time from treatment to death from any cause, assessed up to 3 years.
Objectivel response rate (ORR)
Time Frame: Response is assessed once every 8 weeks, from the day of treatment to the date of first documented progression, assessed up to 3 years.
Defined as numbers of patients achieved complete response and partial response of treatment.
Response is assessed once every 8 weeks, from the day of treatment to the date of first documented progression, assessed up to 3 years.
Duration of response (DOR)
Time Frame: From the day of treatment to the date of first documented progression, assessed up to 3 years.
Defined as from the first date when criteria for response is met until the first date when the criteria for progression or death is met.
From the day of treatment to the date of first documented progression, assessed up to 3 years.
4.Clinical Benefit Rate (CBR)
Time Frame: From the day of treatment to the date of first documented progression, assessed up to 3 years.
ORR is defined as percentage of participants with Complete Response, Partial Response or Stable Disease≥24 weeks, assessed by the investigators according to the RECIST v1.1.
From the day of treatment to the date of first documented progression, assessed up to 3 years.
Adverse event(AE)
Time Frame: From the day of treatment to the date of first documented progression, assessed up to 3 years.
Adverse event related to treatment.
From the day of treatment to the date of first documented progression, assessed up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Women and Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

July 31, 2021

First Submitted That Met QC Criteria

August 7, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 7, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDWCH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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