breasr cancer
Conditions
Interventions
1:Tucidinostat combined with AI (±OFS)
2:AI alone (±OFS)
Sponsors
The Second Hospital of Dalian Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Adult female aged 18 years or older; 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; 3.Postmenopausal women, including natural menopausal and premenopausal reached the intervention level of menopause through ovarian function suppression or castrating therapy; 4.The primary breast tumor was pathologically confirmed as invasive carcinoma through puncture biopsy, clinical T2 - T4c, any N, M0(including unilateral ipsilateral supraclavicular lymph node involvement) which all performed by AJCC version 7 clinical staging, The primary tumor is required to be palpable on physical examination and to have a maximum tumor diameter of at least 2.0 cm based on physical examination or imaging evaluation; According to the criteria of the central laboratory, invasive carcinoma should be demonstrated by immunohistochemistry with estrogen receptor (ER) ratio >= 10% and/or progesterone receptor (PR) ratio >= 1%, HER2 negative (HER2 negative is defined as: IHC1+/IHC0;IHC2 + and FISH -; investigator-determined HER2 negative) 5.For tumor diseases, one preoperative neoadjuvant chemotherapy regimen is allowed, which requires early evaluation (2-4 courses) for poor efficacy, including stable disease (SD) after 2~4 courses of neoadjuvant therapy for newly diagnosed operable patients, and stable disease (SD) or progressive disease (PD) after 2~4 courses of neoadjuvant therapy for newly diagnosed inoperable patients 6.If receiving neoadjuvant chemotherapy, the primary breast tumor should be biopsied again when the efficacy was evaluated poor, ?the expression status of hormone receptor, HER2 and Ki67 should be determined, and only HR positive and HER2 negative can be considered for inclusion; 7.Absolute neutrophil count of at least 1500 cells per µL, platelet count of at least 100000 per µL, haemoglobin concentrations of 9.0 g/dL or higher, total bilirubin concentrations less than 1.5 times the upper limit of normal (ULN), alanine aminotransferase concentrations less than to 2.5 times the ULN , and serum creatinine concentrations less than 1.5 times the ULN; 8.To conduct holistic and comprehensive biomarker and related studies, patients should be volunteer to participate in this clinical trial by signing a written informed consent and?agree to provide the required biopsies at baseline and surgery (or termination of treatment).
Exclusion criteria
Exclusion criteria: 1.Inflammatory breast cancer, defined as clinically significant erythema of the breast and/or cutaneous lymphatic infiltration (excluding tangerine peel-like changes caused by direct invasion of the skin by the tumor); 2.Clinical or radiographic evidence of metastatic disease (excluding unilateral ipsilateral supraclavicular lymph node involvement); 3.Any hormone replacement therapy for invasive breast cancer (including Megestrol acetate/raloxifene) within the first week of enrollment; 4.Patients who had undergone major surgical or significant trauma within 4 weeks before enrollment ,or who were expected to undergo major surgical treatment; 5.Other malignancies (excluding non-melanoma skin cancer,breast lobular carcinoma in situ, contralateral ductal carcinoma in situ without endocrine therapy, and cervical carcinoma in situ) within 5 years before enrollment; 6.Patients with a history of allergy to the drug components; 7.History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8.Concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that, in the investigator's judgment, seriously endanger the patient's safety or affect the completion of the study; 9.Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia; 10.Researchers determined inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical response rate;modified Preoperative Endocrine Prognostic Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathologic complete rate;Changes of Ki67 expression before and after neoadjuvant endocrine therapy;Breast conserving surgery rate;iDFS rate of MPEPI =0 patients; | — |
Countries
China
Contacts
Public ContactLi Man
The Second Hospital of Dalian Medical University
Outcome results
None listed