Triple-negative Breast CancerPhase 2NCT04192903
Chidamide Combined With Cisplatin for Relapsed or Metastatic Triple-negative Breast Cancer
A Phase 2 study testing Chidamide combined with Cisplatin in people with Triple-negative Breast Cancer, run by Fudan University at 2 sites in China.
Trial summary
The goal of this clinical trial is to evaluate therapeutic efficacy and safety of Chidamide combined with Cisplatin for relapsed or metastatic triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- Chidamide combined with Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesChina
- Study dates
- 25 Dec 2019to 1 Jun 2022
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-75 years (including cutoff value).
- Patients with recurrent or metastatic breast cancer , histologically proven invasive breast carcinoma with triple negative receptor status (Estrogen receptor, Progesterone receptor and HER2 negative by IHC and FISH) by histopathology in Department of Pathology, Fudan University Cancer Center, Local recurrence needs to be confirmed by the physician that is unresectable.
- Prior treatment:Previously received no more than 1prior lines of systemic chemotherapy for metastatic breast cancer, and progressed after treatment, chemotherapy regimen did not contain cisplatin or did not demonstrate cisplatin resistance (disease progression during the cisplatin treatment period or within 3 months after completion);
- At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
- Eastern Cooperative Oncology Group Performance Status of 0-1.
- Life expectancy ≥ 3 months.
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- Adequate function of major organs meets the following requirements (no blood components and cell growth factors have been used within 14 days before randomization):
- Neutrophils ≥ 1.5×10^9/L Platelets ≥ 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
- Subjects voluntarily joined the study, signed informed consent.
Who cannot join
- Previously received any HDAC inhibitor treatment.
- The subject has untreated central nervous system (CNS) metastases.
- Patients who have undergone systemic, radical brain or meningeal metastasis (radiotherapy or surgery), but have been confirmed to have been stable for at least 4 weeks, and who have stopped systemic hormonal therapy for more than 2 weeks without clinical symptoms can be included.
- Previously received more than 2 lines of systemic chemotherapy for metastatic breast cancer.
- 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.
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- Received systemic therapy such as chemotherapy, molecular targeted therapy or other clinical trial drugs within 4 weeks before enrollment;
- Patients with other malignant tumors within 5 years or at the same time( except for cured skin basal cell carcinoma and cervical carcinoma in situ).
- Have undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or are expected to undergo major surgery.
- Have 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.
- History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
- History of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥ grade 2 found in screening.
- Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test. Childbearing female who refuse to accept any contraception practice during the treatment period and for at least 8 weeks after the last dose of chemotherapy.
- Determined by the physician, any serious coexisting disease might be harmful to the patient's safety or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction, active infection etc.).
- History of neurological or psychiatric disorders, including epilepsy or dementia.
- The investigator determined who was not suitable for the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xichun Hu, MD,PhD, 64175590 ext. 85006, huxicun@gmail.com
Zhonghua Wang, MD, 64175590 ext. 85000, zhonghuawang95@hotmail.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xichun Hu, M.D., Ph.D., 64175590 ext. 5006, ycmnankai@126.com
About this study
The goal of this clinical trial is to evaluate therapeutic efficacy and safety of Chidamide combined with Cisplatin for relapsed or metastatic triple-negative breast cancer.
Read the detailed description
Triple-negative breast cancer (TNBC), the most difficult-to-treat breast cancer subtype, lacks well-defined treatment options. This is a prospective, single-center, one-arm, open-label, phase II clinical trial evaluating the efficacy and safety of chidamide in combination with cisplatin in subjects with relapsed or metastatic triple-negative breast cancer.
- Conditions
- Triple-negative Breast Cancer
- Being tested
- Chidamide combined with Cisplatin
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide combined with CisplatinDrug
Chidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 75mg/m2 ivgtt D1 Chidamide :20mg PO Biw, 2 week on , 1 week off
| Study group | Role | What they receive |
|---|---|---|
| Chidamide combined with Cisplatin | Experimental | Chidamide: 30mg,PO,biw one week before cycle 1 treatment
Combined treatment period:
Cisplatin 75mg/m2 ivgtt D1 Chidamide :20mg PO Biw, 2 week on , 1 week off Patients whose efficacy was evaluated as Complete Response (CR) / Partial Response (PR) / Stable Disease (SD) after the end of the combined treatment period received maintenance treatment with chidamide combined with cisplatin reduction.
Maintenance treatment period:
Cisplatin 25mg/m2 ivgtt D1 Chidamide :20mg PO Biw, 2 week on , 1 week off Receives: Drug: Chidamide combined with Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Defined as numbers of patients achieved complete response and partial response of treatment
Measured: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Secondary outcomes (5)
Progression-free survival (PFS)
Defined as the time from randomization until objective tumor progression or death
Measured: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Overall survival (OS)
Defined as from the date of inclusion to date of death, irrespective of cause
Measured: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Duration of remission (DOR)
Defined as from date of complete remission to date of progression, relapse, or death from any cause
Measured: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Clinical Benefit Rate (CBR)
Proportion of participants with a clinical benefit (CB), defined as an objective response (CR or PR), or stable disease for at least 24 weeks, as determined by the Investigator through the use of RECIST v1.1.
Measured: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Adverse event(AE)
Adverse event related to treatment
Measured: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start25 Dec 2019
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- xichun Hu,MD, Study director, Fudan UniversityJian Zhang,MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192903
- Sponsor's protocol ID
- 1910208-9
- Status last verified
- Apr 2022
- First submitted
- 7 Dec 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Combined With Cisplatin for Relapsed or Metastatic Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04192903
- Acronym / sponsor ID
- 1910208-9
- Conditions
- Triple-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate therapeutic efficacy and safety of Chidamide combined with Cisplatin for relapsed or metastatic triple-negative breast cancer.
Detailed description
Triple-negative breast cancer (TNBC), the most difficult-to-treat breast cancer subtype, lacks well-defined treatment options. This is a prospective, single-center, one-arm, open-label, phase II clinical trial evaluating the efficacy and safety of chidamide in combination with cisplatin in subjects with relapsed or metastatic triple-negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide combined with Cisplatin | Experimental | Drug: Chidamide combined with CisplatinChidamide: 30mg,PO,biw one week before cycle 1 treatment Combined treatment period: Cisplatin 75mg/m2 ivgtt D1 Chidamide :20mg PO Biw, 2 week on , 1 week off Patients whose efficacy was evaluated as Complete Response (CR) / Partial Response (PR) / Stable Disease (SD) after the end of the combined treatment period received maintenance treatment with chidamide combined with cisplatin reduction. Maintenance treatment period: Cisplatin 25mg/m2 ivgtt D1 Chidamide :20mg PO Biw, 2 week on , 1 week off |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients aged 18-75 years (including cutoff value).
- Patients with recurrent or metastatic breast cancer , histologically proven invasive breast carcinoma with triple negative receptor status (Estrogen receptor, Progesterone receptor and HER2 negative by IHC and FISH) by histopathology in Department of Pathology, Fudan University Cancer Center, Local recurrence needs to be confirmed by the physician that is unresectable.
- Prior treatment:Previously received no more than 1prior lines of systemic chemotherapy for metastatic breast cancer, and progressed after treatment, chemotherapy regimen did not contain cisplatin or did not demonstrate cisplatin resistance (disease progression during the cisplatin treatment period or within 3 months after completion);
- At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
- Eastern Cooperative Oncology Group Performance Status of 0-1.
Key exclusion criteria (17 listed)
- Previously received any HDAC inhibitor treatment.
- The subject has untreated central nervous system (CNS) metastases.
- Patients who have undergone systemic, radical brain or meningeal metastasis (radiotherapy or surgery), but have been confirmed to have been stable for at least 4 weeks, and who have stopped systemic hormonal therapy for more than 2 weeks without clinical symptoms can be included.
- Previously received more than 2 lines of systemic chemotherapy for metastatic breast cancer.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chidamide combined with CisplatinChidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 75mg/m2 ivgtt D1 Chidamide :20mg PO Biw, 2 week on , 1 week off | Drug | Chidamide combined with Cisplatin |
Primary outcome
Overall response rate (ORR)
Time frame: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Defined as numbers of patients achieved complete response and partial response of treatment
5 secondary outcomes
Progression-free survival (PFS)
Time frame: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Overall survival (OS)
Time frame: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Duration of remission (DOR)
Time frame: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Clinical Benefit Rate (CBR)
Time frame: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Adverse event(AE)
Time frame: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xichun Hu,MD study director
Fudan University
Jian Zhang,MD principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide combined with Cisplatin in people with Triple-negative Breast Cancer, run by Fudan University at 2 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 9 inclusion and 17 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 Xichun Hu, M.D., Ph.D. (64175590 ext. 5006, ycmnankai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: From the day of treatment to the date of first documented progression，up to 18 months after the last patient's enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2022.