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Hormone Receptor-positive Advanced Breast CancerPhase 2NCT05808582

Chidamide Combined With Fulvestrant for HR+/HER2-advanced Breast Cancer

A Phase 2 study testing chidamide，fulvestrant in people with Hormone Receptor-positive Advanced Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

evaluate the efficacy and safety of chidamide combined with fulvestrant for HR+ABC Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
chidamide，fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 May 2023to 1 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, female.
  • Both postmenopausal and premenopausal for hormone receptor positive patients, but premenopausal patients need to be given concomitant ovarian function suppression (OFS) therapy (criteria for menopause: "Judgment Criteria for Menopause after Adjuvant Therapy and Consensus on Clinical Application of Aromatase Inhibitors for Premenopausal Female Breast Cancer Patients in China").
  • Patients with HR-positive (ER-positive, PR-positive or negative) and HER2-negative breast cancer confirmed by histopathology, defined as follows.
  • Pre-enrollment disease status of non-surgically resectable locally advanced or metastatic breast cancer.
  • At least one extracranial measurable lesion as defined by RECIST V1.1 criteria or bone metastases alone.
  • Progress after previous treatment with CDK4/6 inhibitor combined with any aromatase inhibitor (after previous treatment with CDK4/6 inhibitor combined with aromatase inhibitor, you can enter the study directly or re-enter the group after chemotherapy); ; The total number of previous rescue treatments is ≤3; Previously received rescue chemotherapy ≤1 line; Time interval from the last treatment: (a) If the last treatment is endocrine therapy, it needs ≥2 weeks; (b) If the last treatment is chemotherapy, it needs ≥4 weeks;
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  • ECOG PS score: 0-1.
  • Organ function meets the requirement.
  • expected survival ≥ 3 months.
  • Subjects of childbearing potential need to have a negative pregnancy test within 7 days prior to initiation of treatment and must use an appropriate method of contraception during treatment and for three months after completion of treatment.
  • Patients are fully informed and voluntarily sign an informed consent form.

Who cannot join

  • Prior treatment with any HDAC inhibitor or fulvestrant.
  • known hypersensitivity to the drug components of this trial.
  • have inflammatory breast cancer at the time of screening
  • clinical evidence or history of central nervous system metastases (CS) and/or carcinomatous meningitis, soft meningeal disease
  • inability or unwillingness to swallow medications or receive intramuscular injections
  • have gastrointestinal insufficiency or gastrointestinal disease that can significantly interfere with the absorption of study drug (e.g., uncontrolled ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
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  • History of immunodeficiency, including testing positive for HIV, or having other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
  • other malignancies (except cured basal cell carcinoma of the skin, cervical carcinoma in situ and thyroid cancer) within the previous 5 years or concurrently
  • having undergone a major surgical operation or significant trauma within 4 weeks prior to initiation of treatment, or where the patient is expected to undergo major surgical treatment
  • Inability to understand or follow study guidelines and requirements.
  • Those who are judged by the investigator to be unsuitable for participation in this study.

About this study

Official title: Multicenter, Single-arm, Open Clinical Study of Chidamide in Combination With Fulvestrant in HR+/HER2-advanced Breast Cancer That Has Failed Prior CDK4/6 Inhibitor Combined With Aromatase Inhibitor Therapy

evaluate the efficacy and safety of chidamide combined with fulvestrant for HR+ABC

Read the detailed description

This trial is a single-arm study. Designed to evaluate the efficacy and safety of chidamide combined with fulvestrant for HR+/HER2- advanced breast cancer that has failed previous CDK4/6 inhibitor combined with aromatase inhibitor therapy

Being tested
chidamide，fulvestrant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chidamide，fulvestrantDrug

    Also called Regular Visits

    chidamide combined with fulvestrant

Study groups in NCT05808582
Study groupRoleWhat they receive
chidamide combined with fulvestrantExperimentalfulvestrant
Receives: Drug: chidamide，fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

    Measured: 2 years

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set

    Measured: 2 years

  2. clinical benefit rate（CBR）

    Defined as the percentage of patients who achieved complete remission (CR), partial remission (PR) and stable disease (SD) for ≥24 weeks as a percentage of the total number of patients in the analysis set.

    Measured: 2 years

  3. The Number of Participants Who Experienced Adverse Events (AE)

    Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05808582
Sponsor's protocol ID
CSIIT-C37
Status last verified
Apr 2023
First submitted
6 Mar 2023
Last updated
14 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing chidamide，fulvestrant in people with Hormone Receptor-positive Advanced Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05808582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.

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