Study to compare Chemotherapy and Hormone therapy performed before surgery in Breast Cancer patients who have positive hormone receptors: response evaluation to proposed treatments

Phase 3

• Conditions: BREAST CANCER; C50.9

• Registration Number: RBR-7wjw5z6
• Lead Sponsor: Instituto de Medicina Integral Prof. Fernando Figueira - IMIP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-06
• Last Update Posted: 29 May 2023
• Study Completion: 2024-12-04

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Histological diagnosis of invasive breast carcinoma with Estrogen Receptor (ER) expression > 50%, Ki 67 ? 35%, HER2 negative and Progesterone Receptor (PR) > 20%;
• Tumor ? 2cm on ultrasound or Tumor < 2cm with at least 1 axillary lymph node diagnosed with metastatic involvement – Metastatic involvement should be defined by cytology (USG guided FNA of the suspected lymph node) or histology (suspected lymph node core biopsy or biopsy of sentinel lymph node performed before neoadjuvant therapy)

Exclusion Criteria

Metastatic disease;
Inflammatory breast cancer;
Impossibility of surgical or drug treatment due to comorbidities such as decompensated heart failure or hematological and biochemical parameters within the patterns of patterns described:
Hemoglobin < 7.0 g / dL;
FA ?1.5 times the reference value;
Neutrophil count < 1500 U /mm3 ;
Platelet count < 100,000 U /µL;
Serum creatinine > 1.5 mg / dL;
Score > 2 on the ECOG Scale - Eastern Cooperative Oncology Group;
Contraindication to the use of at least one of the drugs proposed for the study;
Ongoing pregnancy.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare clinicopathological response rates to HTN and QTN in patients with HER2-negative luminal subtype breast tumors using CPS+EG.

Secondary Outcome Measures

Name	Time	Method
Assess the association between the response assessment modalities to neoadjuvant therapies: RCB, PEPI and CPS+EG;;Compare the quality of life between the therapies proposed at the start of treatment, 3 months after the start of treatment and 6 months after the end of treatment