A clinical trial to evaluate the feasibility and efficacy of using Anastrozole before surgery for patients with hormone-related localized Breast Cancer with low proliferative capacity
- Conditions
- Malignant neoplasm of breastC04.557.470.200
- Registration Number
- RBR-5pygzhj
- Lead Sponsor
- Hospital de Câncer de Barretos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Age 18 years or older; histologically confirmed unilateral primary invasive carcinoma of the breast;
estrogen receptor positive (Allread =6); progesterone receptor positive (any percentage value); HER-2 negative; histological grade according to Scarf-Bloom-Richardson 1 or 2; Ki-67 antigen <50% on immunohistochemistry; TNM staging by 8th Edition cT2-4c cNqq M0; tumor clinically palpable and larger than 2cm on palpation and/or imaging examination; functional capacity assessed by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 - 2; adequate hematologic, renal, and hepatic function; absence of any psychological, familial, sociological, or geographic condition that would potentially hinder adherence to the study protocol and follow-up schedule; patient agreeent to provide the required research biopsies from baseline, week 4 (re-biopsy) and surgery for biomarker and biorepository research.
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion; excisional biopsy of current breast cancer; hormone replacement therapy of any kind, megestrol acetate or raloxifene within one week prior to inclusion; axillary staging surgical procedure prior to study entry; clinical or radiographic evidence of metastatic disease; skin implants in the breast that prevent the required research biopsies or may interfere with palpation of the breast lesion; treatment for cancer, including surgery, radiation therapy, chemotherapy, biotherapy, hormone therapy, or any investigational product prior to study entry; history of previous invasive breast cancer; patient with any other concomitant serious and/or uncontrolled medical condition that may, in the opinion of the Investigator, cause unacceptable safety risks, contraindicate the patient's participation in the clinical trial or compromise adherence to the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active, untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.) or limit life expectancy to = 5 years.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of endocrine therapy with anastrozole as a function of the rate of patients with ki67=10% after 4 weeks and Preoperative Endocrine Prognostic Index (PEPI) score 0 on the surgical specimen.
- Secondary Outcome Measures
Name Time Method