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Triple-negative Breast CancerPhase 2NCT05438706

A Clinical Study of the Efficacy and Safety of Chidamide in Combination With Camrelizumab and Carboplatin or Capecitabine in the Second and Third Line Treatment of Relapsed/Metastatic Triple-negative Breast Cancer

A Phase 2 study testing chidamide, camrelizumab and carboplatin in people with Triple-negative Breast Cancer, run by Fudan University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the efficacy and safety of chidamide in combination with camrelizumab and carboplatin or capecitabine in the second and third line treatment of relapsed/metastatic triple-negative breast cancer Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
chidamide, camrelizumab and carboplatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
10 Jul 2022to 10 Jul 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

  • The patients voluntarily participated in the study and signed the informed consent form
  • 18-75 years old, female
  • EC0G score 0-1
  • Expected survival time ≥ 3 months
  • Patients with recurrent / metastatic breast cancer confirmed by histopathology, with negative expression of ER or PR and negative expression of HER2; Patients with local recurrence need to be confirmed by the investigator that radical resection is impossible
  • Previous anti-tumor regulations (Patients has previously received first-line chemotherapy and disease progression, and at most has received second-line treatment (recurrence and metastasis during adjuvant treatment will be regarded as first-line treatment), Patients who have previously received taxoids drugs)
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  • Patients were preferentially enrolled into the chidamide in combination with camrelizumab and capecitabine group( except fo who had failed to receive capecitabine treatment in the past)
  • If the investigator thinks who is suitable to be enrolled in the chidamide in combination with camrelizumab and carboplatin group (such as genetic recombination deficiency, high HRD evaluation score or BRCA1/2 gene mutation, etc.), is preferred to enter this group
  • At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
  • The functions of important organs meet the following requirements (no blood components and cell growth factors have been used within 2 weeks before enrollment) ANC ≥ 1.5 × 109 /L; PLT ≥ 75 × 109 /L. Hb ≥ 90 g/L TBIL ≤ 1.5×ULN (upper limit of normal) ALT and AST ≤ 2.5×ULN. Urea / urea nitrogen (BUN) and creatinine (CR) ≤ 1.5 × ULN, or creatinine clearance ≥ 60ml/min/1.73m2 Left ventricular ejection fraction (LVEF) ≥ 50% QTcF(Fridericia correction) < 470 ms INR≤1.5×ULN，APTT≤1.5×ULN

Who cannot join

  • Previously treated with histone deacetylase inhibitors (HDACi)
  • Previously treated with pd-1/pd-l1 inhibitors
  • Untreated imaging confirmed central nervous system metastasis (except asymptomatic brain metastasis)
  • Patients who have received systematic, radical brain or meningeal metastasis treatment (radiotherapy or surgery) in the past, but have been stable for at least 4 weeks as confirmed by imaging, have stopped systemic hormone treatment for more than 2 weeks, and have no clinical symptoms can be included
  • There were ascites, pleural effusion and pericardial effusion with clinical symptoms in the baseline period, requiring drainage, or serous effusion drainage within 4 weeks before the first dose
  • Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption
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  • Systematic treatment such as chemotherapy, molecular targeted therapy or other clinical trial drugs were received within 4 weeks before enrollment, except for observational studies
  • Prior malignancy active within the previous 5 years (except for curable cancers, such as or Non-Melanocytic Tumors of the Skin or carcinoma in situ of the cervix)
  • Had major surgical operation or obvious trauma within 4 weeks before enrollment, or it is expected that the patient will receive major surgical treatment
  • Allergy to the drug components of this study
  • Active HBV and HCV infection; Except for the patients with stable hepatitis B (DNA titer shall not be higher than 500 IU/ml or copy number <1000 copies/ml) and cured hepatitis C (HCV RNA detection is negative)
  • History of immunodeficiency, including HIV test positive, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation
  • Any heart disease, including (1) angina pectoris; (2) Arrhythmia requiring medication or clinically significant; (3) Myocardial infarction; (4) Heart failure; (5) Any other heart disease judged by the researcher as unsuitable for the test; The severity of abnormal cardiac or renal function in screening period is ≥ II
  • Pregnant women, lactating women or fertile women , Or subjects of childbearing age who are unwilling to take effective contraceptive measures during the study period and at least 3 months after the last dose
  • According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study (such as severe hypertension, diabetes, thyroid disease, active infection, etc.)
  • History of neurological or mental disorders, including epilepsy or dementia
  • The investigator determined who was not suitable for the study.

Trial locations and contacts

1 site in 1 country.

Jian Zhang, MD contact

+8664175590 ext. 85000

syner2000@163.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

To evaluate the efficacy and safety of chidamide in combination with camrelizumab and carboplatin or capecitabine in the second and third line treatment of relapsed/metastatic triple-negative breast cancer

Read the detailed description

This study is a prospective, single-center, single-arm, open-label clinical study. Successfully screened patients with relapsed/metastatic triple-negative breast cancer will receive chidamide and camrelizumab at the prescribed doses Combined with carboplatin or capecitabine therapy, Chidamide single drug should be taken for lead-in therapy before combined therapy.

Being tested
chidamide, camrelizumab, carboplatin, capecitabine
Keywords
chidamide, camrelizumab, carboplatin, capecitabine, relapsed/metastatic, triple-negative breast cancer
Medical subject headings
Triple Negative Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • chidamideDrug

    Chidamide, an HDAC inhibitor

  • camrelizumabDrug

    Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd, recently received conditional approval in China for the treatment of relapsed or refractory classical Hodgkin lymphoma. The drug is also being investigated as a treatment for various other malignancies, including B cell lymphoma, oesophageal squamous cell carcinoma, gastric/gastroesophageal junction cancer, hepatocellular carcinoma, nasopharyngeal cancer and non-squamous, non-small cell lung cancer.

  • carboplatinDrug

    Carboplatin [diammine(1,1-cyclobutanedicarboxylato)platinum(II)] is one of the most promising second generation platinum compounds. Its greater chemical stability in comparison with cisplatin accounts for its lower reactivity with nucleophilic sites of DNA.

  • capecitabineDrug

    Capecitabine is an oral prodrug of 5-fluorouracil (5-FU) and approved for treatment of various malignancies. Hereditary genetic variants may affect a drug's pharmacokinetics or pharmacodynamics and account for differences in treatment response and adverse events among patients.

Study groups in NCT05438706
Study groupRoleWhat they receive
Arm 1Experimentalchidamide in combination with camrelizumab and capecitabine
Receives: Drug: chidamide; Drug: camrelizumab; Drug: capecitabine
Arm 2Experimentalchidamide in combination with camrelizumab and carboplatin
Receives: Drug: chidamide; Drug: camrelizumab; Drug: carboplatin

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 12 weeks

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

    Measured: Up to approximately 30 months

  2. Overall Survival (OS)

    Time from date of randomization to the date of death from any cause

    Measured: Up to approximately 30 months]

  3. Disease control rate(DCR)

    DCR is defined as cases where objective remission(assessed as complete remission or partial remission according RECIST 1.1 standard) or stable disease during the study.

    Measured: Up to approximately 12 weeks

  4. Clinical Benefit Rate (CBR)

    Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1.CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm

    Measured: Up to approximately 12 weeks

Timeline

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

  1. First posted30 Jun 2022
  2. Study start10 Jul 2022 (estimated)
  3. Primary completion10 Nov 2023 (estimated)
  4. Study completion10 Jul 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438706
Sponsor's protocol ID
CSIIT-C21
Status last verified
Jun 2022
First submitted
25 Jun 2022
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing chidamide, camrelizumab and carboplatin in people with Triple-negative Breast Cancer, run by Fudan University at 1 site 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 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 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Jian Zhang, MD (+8664175590 ext. 85000, syner2000@163.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: Up to approximately 12 weeks). 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 NCT05438706.

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 30 Jun 2022.

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