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Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer

NCT07801898 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-09-03

No results posted yet for this study

Summary

The goal of this investigator-initiated, open-label, phase II clinical trial is to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with endocrine therapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, Ki67 \> 20% invasive breast cancer.

The main questions it aims to answer are:

What is the objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 criteria at the completion of neoadjuvant treatment?

What are the changes in Ki-67 proliferation index, pathological tumor response, pathological complete response (pCR) rate, disease-free survival (DFS), and safety profile?

Participants will receive standard anthracycline- and taxane-based chemotherapy with letrozole. The chemotherapy regimen was either six cycles of docetaxel, epirubicin, and cyclophosphamide (TEC) every 3 weeks or four cycles of epirubicin plus cyclophosphamide followed by four cycles of a taxane (EC→T). The investigator could replace docetaxel or paclitaxel with nanoparticle albumin-bound paclitaxel (nab-paclitaxel), depending on the patient's clinical features and treatment tolerance.

Patients took letrozole 2.5 mg orally once daily throughout neoadjuvant systemic therapy. Premenopausal patients also received ovarian function suppression with leuprorelin acetate (3.75 mg) subcutaneously every 28 days, from the start of neoadjuvant treatment until definitive surgery. A safety assessment will be conducted for each treatment cycle in the patient. During the neoadjuvant therapy phase, tumor assessment will be performed at least after 4 cycles and preoperatively; postoperatively, assessments will be conducted every 3 months using imaging modalities to evaluate the tumor status until disease progression, death, or completion of 3 years postoperatively occurs. Following surgery, all patients will receive adjuvant therapy selected by the investigator based on their individual clinical condition.

Conditions

  • Invasive Breast Cancer (Stage I-III)

Interventions

DRUG

NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide

Patients received NaCET consisting of standard anthracycline- and taxane-based chemotherapy administered concurrently with letrozole. The preferred chemotherapy regimen was TEC, comprising docetaxel, epirubicin, and cyclophosphamide, administered every 3 weeks for six cycles. A sequential EC→T regimen, consisting of four cycles of epirubicin plus cyclophosphamide followed by four cycles of a taxane, was also permitted. At the investigator's discretion, nab-paclitaxel could be substituted for docetaxel or paclitaxel according to individual patient characteristics, treatment tolerance, and clinical considerations. Letrozole was administered orally at 2.5 mg once daily throughout the entire neoadjuvant chemotherapy period. Premenopausal patients additionally received ovarian function suppression with leuprorelin 3.75 mg subcutaneously every 28 days, beginning at initiation of neoadjuvant treatment and continuing throughout the preoperative treatment period.

Sponsors & Collaborators

  • The Second Hospital of Anhui Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2029-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801898 on ClinicalTrials.gov