Breast cancer take a leading position in the structure of morbidity and mortality from malignant tumors among women. Today the interest of many scientists and pharmaceutical companies is focused on the study of metastatic breast cancer forms. While we obtain little experimental data and practical research about the treatment of locally advanced forms. In this regard, the study of new neoadjuvant drug therapy regimen for estrogen-receptor positive breast cancer in premenopausal woman is very relevant. The proposed research will be the absolutely innovative investigation worldwide. The study will consist of two modes of treatment, combined hormone therapy with CDK4/6-ingibitors and chemotherapy (the control), each replicated four times in a randomized, complete block design. This research aims to improve the results of treatment, namely to increase the percentage of successfully treated patients and reduce toxicity from treatment. Primary study endpoints will include the frequency of objective response and complete pathomorphological response (according to the Miller-Payne classification). Secondary endpoints will include a decrease of the Ki67 level in postoperative material compared to primary biopsy, the frequency of organ-preserving operation after neoadjuvant treatment and quality of life. Study hypothesis: neoadjuvant combined hormone therapy with CDK4/6-ingibitors in premenopausal women with luminal breast cancer leads to at least the same results as neoadjuvant chemotherapy, but with less toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Neoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67
Neoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67
Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
St-Peterburg, Russia
frequency of objective response
according to the results of ultrasound of the mammary glands and / or mammography
Time frame: 24 weeks
complete pathomorphological response
according to the Miller-Payne classification
Time frame: 24 weeks
change of the Ki67 level in postoperative material compared to primary biopsy
compared to primary biopsy
Time frame: 24 weeks
the frequency of organ-preserving operation after neoadjuvant treatment
in bouth groups
Time frame: 24 weeks
quality of life
The quality of life questionnaire EORTC QLQ-C30
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.