Malignant neoplasm of breast
Conditions
Interventions
All 59 patients included in the study will receive anastrozole 1 tablet 1 mg/day, continuously, until the day before the surgical procedure or exclusion from the study (if disease progression during e
if they present with ki-67 >10% in the re-biopsy the endocrine therapy will be suspended and the patient will be excluded from the study and redirected to neoadjuvant chemotherapy (routine care) or su
D03.383.129.799.275
Sponsors
Hospital de Câncer de Barretos
Hospital de Câncer de Barretos
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Assess the feasibility of the study by assessing acceptance to participate in the study (recruitment rate = 50%) and inclusion rate of >2 patients/month. ;Clinical response rate per RECIST 1.1 (partial response + complete response) by physical examination, mammography, ultrasound and magnetic resonance imaging between baseline and final assessment (before surgery). ;Clinical response rate per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 (partial response + complete response) by physical examination, mammography, ultrasound and magnetic resonance imaging between baseline and final assessment (before surgery) in the group of patients classified as Luminal A.;Evaluate the median time (in days) until the best response was obtained by physical examination and breast ultrassound, and longitudinally evaluate the medians of the largest diameters, tumor volume, and the percentages of tumor reduction.;To assess the time to deterioration of quality of life (TDQV) by considering the value of worsening quality of life in the summed scores of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and BR-45 with a cut-off of 10 points.;To evaluate median recurrence-free survival and identify prognostic variables by Cox regression analysis;To evaluate the rate of conservative surgery among patients treated with anastrozole and the rate of mastectomy conversion or inoperability for conservative surgery after anastrozole;Evaluate the treatment adherence rate measured by the number of pills used / number of pills that should be used in the evaluated period, being considered adequate as >80%.;Evaluation of potential blood biomarkers (microRNAs) by nanostring methodology when comparing results at the time of re-biopsy versus baseline. | — |
Countries
Brazil
Contacts
Public ContactCarlos Paiva
Hospital de Câncer de Barretos
Outcome results
None listed