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Breast CancerPhase 3NCT02482753

Trial of Chidamide in Combination With Exemestane in Patients With Advanced Breast Cancer

A Phase 3 study testing Chidamide and exemestane in people with Breast Cancer, run by Chipscreen Biosciences, Ltd. at 22 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was to evaluate the efficacy and safety of Chidamide in combination with exemestane in postmenopausal 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?
Chidamide and exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
365 participants
Where
22 sitesChina
Study dates
Jul 2015to Feb 2021
Phase
Phase 3
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

  • 18 ~ 75 years old, postmenopausal women;
  • Histological or cytological confirmation of hormone receptor-positive [estrogen receptor (ER) positive and progesterone receptors (PgR) positive or negative] breast cancer;
  • Disease progression or recurrence after at least one endocrine therapy (either in advanced/metastatic setting or adjuvant setting);
  • ≤4 prior therapies (either in advanced/metastatic setting or adjuvant setting), patients may have received one prior chemotherapy;
  • The disease condition is inoperable, stage III or stage IV, at least one measurable lesion or simple bone metastases with no measurable lesions;
  • Last prior therapy intervals: (a) if the last treatment was endocrine therapy, the interval must ≥ 2 weeks; (b) if the last treatment was chemotherapy therapy, the interval must ≥ 4 weeks;
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  • Eastern Cooperative Oncology Group Performance Status: 0~1;
  • Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;
  • Life expectancy ≥ 3 months;
  • Have signed informed consent.

Who cannot join

  • Patients have known central nervous system (CNS) metastases or a history of CNS metastases , or with leptomeningeal disease;
  • Patients with human epidermal growth factor receptor-2 (Her-2) positive;
  • Patients previously received treatment with exemestane;
  • Patients received radiotherapy ≤ 4 weeks prior to study entry;
  • Patients with no measurable lesion (except simple bone metastasis), such as pleural or pericardial effusion, ascites, et al;
  • Patients have uncontrolled or significant cardiovascular disease, including:
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  • 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
  • History of any significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or TdP)
  • History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 450 ms prior to study entry
  • History of cerebrovascular accident
  • Symptomatic coronary heart disease requiring treatment with agents
  • The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period;
  • History of organ transplantation;
  • Patients have not recovered from all clinically relevant toxicities to grade 1 due to prior therapies;
  • Patients have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would interfere the ingestion,transportation or absorption of oral agents;
  • Active infection [Suffered from active infection of bacteria, virus, fungi, mycobacteria, parasites, or other infections (excluding nail bed fungal infections), or require intravenous antibiotic therapy, or antiviral therapy, or hospitalization due to any significant infection events], or persistent fever within 14 days prior to study entry;
  • Patients had organ surgery < 6 weeks prior to study entry;
  • Abnormal liver function [total bilirubin > 1.5×upper limit of normal (> 3×upper limit of normal in case of Gilbert syndrome); Transaminases (ALT, AST) >2.5×upper limit of normal (>5x upper limit of normal patients with liver metastases), abnormal renal function (serum creatinine > 1.5×upper limit of normal);
  • Patients with prior invasive malignancies with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, unless received curative treatment and with documented evidence of no recurrence in the past five years;
  • Any mental or cognitive disorder, that would interfere the ability to understand the informed consent document or the operation and compliance of study;
  • Patients are currently enrolled in another investigational drug study, or completed within 4 weeks prior to study entry, with the exception of patients only in overall survival follow-up;
  • Any other condition which is inappropriate for the study in the opinion of the investigators.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

China22 sites

  • The 307th Hospital of Chinese people's Liberation Army

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100036

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061001

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, Jiangsu, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330009

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Fudan University ZhongShan Hospital

    Shanghai, Shanghai Municipality, 200032

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • Tumor Hospital of Hebei Province

    Shijiazhuang, Hebei, 050019

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Phase III Trial of Chidamide in Combination With Exemestane in Patients With Hormone Receptor-Positive Advanced Breast Cancer (ACE)

This study was to evaluate the efficacy and safety of Chidamide in combination with exemestane in postmenopausal patients with hormone-receptor positive advanced breast cancer.

Read the detailed description

This study including two parts: (1) Part A, open-label design, 20 patients will be enrolled and receive 30 mg Chidamide BIW and 25 mg exemestane QD. The main object of part A is to evaluate the pharmacokinetic and pharmacodynamic profile of Chidamide when in combination with exemestane. (2) Part B, randomized and double-blinded design, 328 patients will be assigned randomly in a 2:1 ratio to experiment group (30 mg Chidamide BIW + 25 mg exemestane QD) and control group (placebo BIW + 25 mg exemestane QD), to evaluate the efficacy and safety of Chidamide when in combination with exemestane in patients with locally advanced or metastatic estrogen receptor-positive breast cancer progressing on endocrine therapy.

Conditions
Breast Cancer
Being tested
Chidamide, exemestane, placebo
Keywords
Chidamide, breast cancer, exemestane, Estrogen Receptor
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ChidamideDrug

    Also called CS055

    30 mg, administered orally twice per week (BIW)

  • exemestaneDrug

    Also called Aromasin

    25 mg, PO daily

  • placeboDrug

    Also called Simulation tablet of Chidamide

    Administered orally twice per week (BIW)

Study groups in NCT02482753
Study groupRoleWhat they receive
Chidamide + exemestane, open-labelExperimentalPatients receive 30 mg Chidamide per week and 25 mg exemestane QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Chidamide; Drug: exemestane
Chidamide + exemestane, double-blindedExperimentalPatients receive 30 mg Chidamide twice per week and 25 mg exemestane QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Chidamide; Drug: exemestane
placebo + exemestane, double-blindedPlacebo comparatorPatients receive placebo twice per week and 25 mg exemestane PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: exemestane; Drug: placebo

What is being measured

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

  1. progression-free survival (PFS), double-blinded period

    PFS is measured from the date of randomization until progression or death, whichever is first met

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

  2. pharmacokinetic profiles of Chidamide, open-label period

    The pharmacokinetic parameters include Area under the plasma concentration versus time curve (AUC) , Peak Plasma Concentration (Cmax), time to reach Cmax (Tmax), mean concentration at steady state (Css)

    Measured: 0,1,2,4,8,12,24,48,72 hours after the first dose of Chidamide on day 2 at induced stage (4 days in total); 0,1,2,4,8,12,24,48,72 hours post-dose on day 1 of cycle 1 at combination treatment stage

  3. pharmacokinetic profiles of exemestane, open-label period

    The pharmacokinetic parameters include Area under the plasma concentration versus time curve (AUC) , Peak Plasma Concentration (Cmax), time to reach Cmax (Tmax), mean concentration at steady state (Css)

    Measured: 0,1,2,4,8,12,24 hours after the first dose of exemestane on day 1 at induced stage (4 days in total); 0,1,2,4,8,12,24,48,72 hours post-dose on day 1 of cycle 1 at combination treatment stage

  4. acetylation level of histone H3, open-label period

    The acetylation level of histone H3 is assayed by enzyme-linked immuno sorbent assay (ELISA).

    Measured: pre-dose of Chidamide on day 2 at induced stage (4 days in total); pre-dose of Chidamide on day 1 of cycle 2 at combination treatment stage

Secondary outcomes (5)

  1. overall survival, double-blinded period

    OS is measured from the date of randomization until death

    Measured: Time from randomization to death from any cause, assessed up to 6 years

  2. duration of response (DOR), double-blinded period

    DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met

    Measured: From the first date of response until the date of first documented progression, assessed up to 3years

  3. objective response rate (ORR), open-label period and double-blinded period

    ORR is defined as percentage of participants with Complete Response and Partial Response, assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: Response is assessed once every 6 weeks, assessed up to 3 years

  4. clinical benefit rate (CBR), open-label period and double-blinded period

    ORR is defined as percentage of participants with Complete Response, Partial Response or Stable Disease ≥ 24 weeks, assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: Response is assessed once every 6 weeks, assessed up to 3 years

  5. PFS, open-label period

    PFS is measured from the start of treatment until progression or death, whichever is first met

    Measured: Time from the start of treatment to the earliest of documented disease progression, or death, 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 posted26 Jun 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionMar 2018
  4. Study completionFeb 2021

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02482753
Sponsor's protocol ID
CDM301
Status last verified
Jan 2022
First submitted
17 Jun 2015
Last updated
12 Jan 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chidamide and exemestane in people with Breast Cancer, run by Chipscreen Biosciences, Ltd. at 22 sites in China.

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 24 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: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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), double-blinded period (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years). The study lists 4 primary outcomes in all. 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 NCT02482753, which also lists 1 linked publication.

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 12 Jan 2022.

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