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Breast CancerPhase 2NCT04999540

Tucidinostat and Fulvestrant in Hormone-receptor Positive Advanced Breast Cancer

A Phase 2 study testing Tucidinostat and Fulvestrant in people with Breast Cancer, run by Guangdong Women and Children Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Tucidinostat and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
No sites listed yet
Study dates
1 Nov 2021to 30 Dec 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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patients have untreated central nervous system (CNS) metastases;
  • Patients with no measurable lesion according to RECIST 1.1;
  • Patients with bilateral breast cancer;
  • Patients with human epidermal growth factor receptor-2 (Her-2) positive;
  • Recurrent or metastatic disease occurs within 2 years during adjuvant endocrine therapy;
  • Patients previously received systemic chemotherapy for recurrent or metastatic breast cancer;
Show all 16Show fewer
  • Patients previously received any HDAC inhibitor or fulvestrant treatment;
  • 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;
  • Inability to swallow, intestinal obstruction or other factors affecting the administration and absorption of the drug;
  • 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;
  • Patients with a history of allergies to the drug components of this regimen;
  • 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;
  • Patients with a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation;
  • 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;
  • Any mental or cognitive disorder, that would interfere the ability to understand the informed consent document or the operation and compliance of study;
  • Any other condition which is inappropriate for the study in the opinion of the investigators.

Trial locations and contacts

No sites are listed yet.

Anqin Zhang contact

020-39151519

sfyrxzx@163.com

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
Tucidinostat, Fulvestrant
Medical subject headings
Breast Neoplasms

What participants receive

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

  • TucidinostatDrug

    30 mg, administered orally twice per week (BIW)

  • FulvestrantDrug

    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.

Study groups in NCT04999540
Study groupRoleWhat they receive
Tucidinostat + FulvestrantExperimentalPatients 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.
Receives: Drug: Tucidinostat; Drug: Fulvestrant

What is being measured

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

  1. Progression Free Survival (PFS)

    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.

    Measured: 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 outcomes (5)

  1. overall survival (OS)

    Defined as from the date of treatment to date of death, irrespective of cause.

    Measured: Time from treatment to death from any cause, assessed up to 3 years.

  2. Objectivel response rate (ORR)

    Defined as numbers of patients achieved complete response and partial response of treatment.

    Measured: Response is assessed once every 8 weeks, from the day of treatment to the date of first documented progression, assessed up to 3 years.

  3. Duration of response (DOR)

    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.

    Measured: From the day of treatment to the date of first documented progression, assessed up to 3 years.

  4. 4.Clinical Benefit Rate (CBR)

    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.

    Measured: From the day of treatment to the date of first documented progression, assessed up to 3 years.

  5. Adverse event(AE)

    Adverse event related to treatment.

    Measured: From the day of treatment to the date of first documented progression, assessed up to 3 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 Aug 2021
  2. Study start1 Nov 2021 (estimated)
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion30 Dec 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
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04999540
Sponsor's protocol ID
GDWCH-001
Status last verified
Aug 2021
First submitted
31 Jul 2021
Last updated
11 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Osborne CK, Schiff R. Mechanisms of endocrine resistance in breast cancer. Annu Rev Med. 2011;62:233-47. doi: 10.1146/annurev-med-070909-182917.

    PubMed 20887199

  • Saxena NK, Sharma D. Epigenetic Reactivation of Estrogen Receptor: Promising Tools for Restoring Response to Endocrine Therapy. Mol Cell Pharmacol. 2010;2(5):191-202.

    PubMed 21499573

  • Turner NC, Ro J, Andre F, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Huang Bartlett C, Zhang K, Giorgetti C, Randolph S, Koehler M, Cristofanilli M; PALOMA3 Study Group. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015 Jul 16;373(3):209-19. doi: 10.1056/NEJMoa1505270. Epub 2015 Jun 1.

    PubMed 26030518

  • Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Tredan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2.

    PubMed 28968163

  • Falkenberg KJ, Johnstone RW. Histone deacetylases and their inhibitors in cancer, neurological diseases and immune disorders. Nat Rev Drug Discov. 2014 Sep;13(9):673-91. doi: 10.1038/nrd4360. Epub 2014 Aug 18.

    PubMed 25131830

  • Jones PA, Issa JP, Baylin S. Targeting the cancer epigenome for therapy. Nat Rev Genet. 2016 Sep 15;17(10):630-41. doi: 10.1038/nrg.2016.93.

    PubMed 27629931

  • Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. doi: 10.1093/annonc/mdv237. Epub 2015 Jun 23.

    PubMed 26105599

  • Zhang Q, Wang T, Geng C, Zhang Y, Zhang J, Ning Z, Jiang Z. Exploratory clinical study of chidamide, an oral subtype-selective histone deacetylase inhibitor, in combination with exemestane in hormone receptor-positive advanced breast cancer. Chin J Cancer Res. 2018 Dec;30(6):605-612. doi: 10.21147/j.issn.1000-9604.2018.06.05.

    PubMed 30700929

  • Jiang Z, Li W, Hu X, Zhang Q, Sun T, Cui S, Wang S, Ouyang Q, Yin Y, Geng C, Tong Z, Cheng Y, Pan Y, Sun Y, Wang H, Ouyang T, Gu K, Feng J, Wang X, Wang S, Liu T, Gao J, Cristofanilli M, Ning Z, Lu X. Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):806-815. doi: 10.1016/S1470-2045(19)30164-0. Epub 2019 Apr 27.

    PubMed 31036468

  • Sabnis GJ, Goloubeva OG, Kazi AA, Shah P, Brodie AH. HDAC inhibitor entinostat restores responsiveness of letrozole-resistant MCF-7Ca xenografts to aromatase inhibitors through modulation of Her-2. Mol Cancer Ther. 2013 Dec;12(12):2804-16. doi: 10.1158/1535-7163.MCT-13-0345. Epub 2013 Oct 3.

    PubMed 24092810

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tucidinostat and Fulvestrant in people with Breast Cancer, run by Guangdong Women and Children Hospital.

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 10 inclusion and 16 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 11 Aug 2021. 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?

Contact Anqin Zhang (020-39151519, sfyrxzx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). 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 NCT04999540, which also lists 10 linked publications.

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 11 Aug 2021.

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Clinical Trial NCT04999540 | AzTrials