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

Clinical and pathological response rates to Neoadjuvant Hormone Therapy and Chemotherapy in patients with Luminal subtype breast tumors: a randomized, open-label, non-inferiority trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-7wjw5z6

Enrollment

Unknown

Registered

2021-12-06

Start date

2022-01-02

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BREAST CANCER

Interventions

A phase III, open, non-inferiority randomized clinical trial will be conducted to assess the effectiveness of neoadjuvant hormone therapy (NHT) when compared to neoadjuvant chemotherapy (NCT). The sa

E02.186.450

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Brazil

Contacts

Public ContactMaria Gouveia

carolinaggoliveira@gmail.com+55(81)988116422

Outcome results

None listed

Source: REBEC (via WHO ICTRP)