Triple Negative Breast Cancer
Conditions
Keywords
Chidamide plus Zimberelimab
Brief summary
The objective of this study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy.
Detailed description
This is a phase II, single center, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy. This study plans to recruit 47 subjects.
Interventions
DRUGChidamide combined with Zimberelimab
Chidamide: 30mg each time, orally, biw; Zimberelimab, 240mg, IV, every 3 weeks.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histological confirmation of triple-negative breast cancer on primary tumour at diagnosis/on biopsy of metastasis. * At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Fail first-line or above anti-tumor treatment. * Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve. * Compliance with the study protocol. * Have provided written and signed informed consent. * Minimum life expectancy 16 weeks.
Exclusion criteria
* Pregnant or breast feeding. * Uncontrolled medical problems. * Evidence of active acute or chronic infection. * Hepatic, renal, cardiac, or bone marrow dysfunction. * Concurrent malignancy or history of other malignancy within the last five years. * Known severe hypersensitivity to Chidamide or Zimberelimab * Patients were unable or unwilling to comply with program requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 18 months | The proportion of patients with measurable tumor size reduction of a predefined amount (complete response \[CR\], partial response \[PR\]) according to the response evaluation criteria in solid tumors (RECIST) version 1.1. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical benefit rate (CBR) | 18 months | The proportion of patients with measurable tumor size stable lasting ≥24 weeks (stable disease \[SD\]) or its size reduction of a predefined amount (complete response \[CR\], partial response \[PR\]) following the response evaluation criteria in solid tumors (RECIST) version 1.1. Complete Response (CR) and Partial Response (PR) are defined in Primary Outcome Measure. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum diameters while on study. Progressive Disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). (Note: the appearance of one or more new lesions is also considered progression). |
| Progression Free Survival (PFS) | 24 months | The interval time from the date of initiation treatment for metastatic breast cancer to the date of the first documented disease progression or death due to any cause. |
| Overall Survival (OS) | 30 months | The interval time from the date of initiation treatment for metastatic breast cancer to the date of death from any cause. |
| Occurrence and severity of AEs | 30 months | Occurrence and severity of AEs by NCI-CTCAE v5. Changes in laboratory parameters (hematology and serum chemistry), vital signs and ECG parameters. Grade 3 or 4 abnormalities in serum chemistry laboratory parameters. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers related to efficacy | 24 months | Baseline tumor biopsy from metastatic or recurrent lesions was required, we analyze and compare the difference of tumor immune microenvironment among patients with different responses to this intervention via the single cell sequencing of acquired tumor biopsy. And peripheral blood samples were collected at baseline, one day before the second cycle treatment and the date of withdrawal from this clinical trial confirmed by researchers. Then peripheral blood mononuclear cell cluster analysis will be performed and compared their changes before and after treatment. |
Countries
China
Outcome results
None listed