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A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer After First-line Chemotherapy

ConditionHR Positive HER2 Negative Advanced Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

To explore the efficacy and safety of Chidamide combined with endocrine for maintenance therapy after first-line chemotherapy for HR+/HER2- breast cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal/premenopausal women aged ≥18 years and ≤70 years;

HR + / HER2 breast cancer confirmed by histology (note: her2-negative is defined as: (1) IHC1 + / IHC0; ②IHC2+ : FISH-);

Confirmed by the histology of locally advanced breast cancer (local treatment) to radical or recurrent metastatic breast cancer;

In the late stage of untreated or experienced a CDK4/6 with endocrine therapy of patients;

Disqualifiers

Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;

Always received HDACi anti-tumor treatment;

This scheme known drug components have allergy history;

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chidamide

    Drug

    Chidamide+ exemestane/Fulvestrant/Letrozole/Anastrozole/Tamoxifen

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cohort A in advanced stages of first-line ± endocrine therapy without CDK4/6 inhibitorsExperimental treatment 1 intervention
Group B: Late-stage first-line ± endocrine therapy with CDK4/6 inhibitors in cohort BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

PFS is defined as the time from the date of treatment to the first date of disease

Time frame
2 year

Secondary outcomes

1

Objective response rate

Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)

Time frame
2 year
2

Disease control rate

his means that in all patients with a tumor who receive a certain treatment, the tumor shrinks or stays stable, and stays that way for a certain amount of time

Time frame
2 year
3

Clinical Benefit Rate (CBR)

CBR is defined as the rate of patients who achieved complete response, partial response, and stable disease for \>= 24 weeks as the best response of treatment.

Time frame
2 year
4

Overall Survival (OS)

OS defined as the time from the first study treatment administration to death from any cause

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov
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