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

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

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

Treatments tested in this trial

  • Chidamide

Treatment groups

60 Participants
are divided into 2 treatment groups