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Trial Title:
A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer After First-line Chemotherapy
NCT ID:
NCT05890287
Condition:
HR Positive HER2 Negative Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Tamoxifen
Letrozole
Fulvestrant
Anastrozole
Exemestane
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
Description:
Chidamide+ exemestane/Fulvestrant/Letrozole/Anastrozole/Tamoxifen
Arm group label:
Cohort A in advanced stages of first-line ± endocrine therapy without CDK4/6 inhibitors
Arm group label:
Late-stage first-line ± endocrine therapy with CDK4/6 inhibitors in cohort B
Other name:
exemestane
Other name:
Fulvestrant
Other name:
Letrozole
Other name:
Anastrozole
Other name:
Tamoxifen
Summary:
To explore the efficacy and safety of Chidamide combined with endocrine for maintenance
therapy after first-line chemotherapy for HR+/HER2- breast cancer
Detailed description:
o explore the efficacy and safety of Chidamide combined with endocrine drug maintenance
after first-line chemotherapy in the treatment of advanced untreated breast cancer; To
explore the efficacy and safety of Chidamidecombined with endocrine drugs after
first-line chemotherapy in the treatment of advanced first-line non-chemotherapeutic
breast cancer after failure of CDK4/6 inhibitors
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Postmenopausal/premenopausal women aged ≥18 years and ≤70 years;
2. HR + / HER2 breast cancer confirmed by histology (note: her2-negative is defined as:
(1) IHC1 + / IHC0; ②IHC2+ : FISH-);
3. Confirmed by the histology of locally advanced breast cancer (local treatment) to
radical or recurrent metastatic breast cancer;
4. In the late stage of untreated or experienced a CDK4/6 with endocrine therapy of
patients;
5. Researchers think that for selecting patients with chemotherapy (step 2022
guidelines recommend for internal transfer, always endocrine therapy resistance or
preferred to rescue patients with endocrine therapy best choice of chemotherapy);
6. One line finish cycle disease after chemotherapy (4 to 8 cycles) to alleviate or
stable, quasi follow-up maintenance treatment: a. late stage A gleam of unused
CDK4/6 inhibitors + endocrine group subjects into the queue for A; b. Used in the
late phase line CDK4/6 inhibitors queue B + endocrine subjects into groups;
7. Into the former group at least one measurable lesions (RECIST v1.1 standard); 8.ECOG
score 0 to 2 points;
9.Always all the acute toxic reaction caused by antineoplastic therapy in screening
before easing to 0 and 1 level (according to the NCI CTCAE 5.0 judgment; Hair loss, other
than toxicity that the investigator believes does not pose a safety risk to the subject);
10. Functions: bone marrow neutrophils absolute acuity 1.5 x 109 / L, platelet acuity 100
x 109 / L, 90 g/L or higher hemoglobin; 11. Liver and kidney function: TBIL acuities were
1.5 x ULN; ALT and AST≤2.5 x ULN; In case of liver metastasis, ALT and AST≤ 5×ULN; BUN
and Cr≤1.5×ULN and creatinine clearance ≥50 ml/min; 12.Voluntary participation in the
clinical trials, signed written informed consent.
Exclusion Criteria:
1. Factors that significantly affect oral drug absorption, such as inability to
swallow, chronic diarrhea, and intestinal obstruction;
2. Always received HDACi anti-tumor treatment;
3. This scheme known drug components have allergy history;
4. Always with other malignant tumours within five years, not including has cured
thyroid papillary carcinoma, cervical carcinoma in situ, basal cell carcinoma or
skin squamous cell carcinoma of the skin;
5. Within 4 weeks before into the group participated in other clinical trials;
6. A history of immune deficiency, including test positive for HIV, or has other
acquired, congenital immunodeficiency disease, or has a history of organ
transplantation;
7. Unable to control the important cardiovascular disease: a history of clinical
significance of long QT, stage or screen between QTc > 450 ms; Severe cardiovascular
injury (greater than a New York Heart Association (NYHA) Class II history of
congestive heart failure), unstable angina or myocardial infarction within the last
6 months, or severe arrhythmia;
8. Pregnancy and lactation women patients or in infertile women baseline pregnancy test
positive; Or participants of childbearing age who were unwilling to use effective
contraception during the study period and for at least 8 weeks after the last
dosing;
9. According to the researcher's judgment, there is serious to endanger the safety of
patients, the patients completed studies or associated with disease (such as severe
hypertension, diabetes, thyroid disease, active infection, etc.);
10. Always have a clear history of neurological or psychiatric disorders, including
epilepsy or dementia, etc.;
11. Reference: subjects had active hepatitis (hepatitis b positive HBsAg and HBV DNA of
500 IU/ml or more; Hepatitis C reference: HCV antibody positive and HCV virus copy
number > upper limit of normal);
12. The researchers determine doesn't fit to the researchers.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
天津市肿瘤医院
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhang
Phone:
13920003358
Email:
doctor3399@163.com
Start date:
May 16, 2023
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05890287
