Patients will be randomized into two groups:
The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by guidelines.
The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4 weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for postmenopausal patients.
- Before and during treatments (every 3 weeks for the NCT group, and every 4 weeks for the NET group), the clinical assessment will be performed for all patients.
- All patients will undergo breast magnetic resonance imaging (MRI) before the start of treatment, after 12 weeks (3 months) of treatment, and after the end of treatment before surgery.
- We will determine the objective tumor response with every measurement method and assess the response according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1.
- Treatment will be continued for 19-21 weeks before surgery for the chemotherapy group and 24 weeks for the endocrine therapy group.
- Ki-67 will be assessed using a sample of the core biopsy before treatment and a surgery specimen after treatment.
- Adverse events will be recorded at every patient visit and will be assessed according to the Common Terminology Criteria for Adverse Events Version 5.0.
- Surgery will be performed between the 24th and 26th week.
- Arm B Patients who will develop PD or SD after 6 months of treatment will be shifted to arm A.
The primary endpoint will be;
- The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements.
- A clinical response included either a complete response (CR), a partial response (PR), Progressive Disease (PD), or Stable Disease (SD) according to the (RECIST) version 1.1.
Secondary endpoints will be;
- The rate of pathological complete response (pCR).
- The rate of breast conservation surgery.
- Ki-67 changes.
- The length of time to maximum response within a treatment period.
- The Adverse events associated with each treatment arm.