Neoadjuvant Chemoradiotherapy Compared to Neoadjuvant Chemotherapy for Luminal-Type Locally Advanced Breast Cancer: A Clinical Study

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSichuan Cancer Hospital and Research Institute

About this trial

This study focuses on preoperative treatment modalities for luminal-type locally advanced breast cancer. Based on modern precision radiotherapy technologies such as MRI-Linac, CyberKnife, and VMAT, it aims to compare the pCR rate, breast conserving surgery (BCS) rate, progression-free survival (PFS), and treatment-related side effects between preoperative neoadjuvant chemotherapy and preoperative neoadjuvant SBRT combined with chemotherapy in patients with this type of breast cancer. The goal is to provide new strategic options for the preoperative treatment of luminal-type locally advanced breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed invasive breast cancer ;

Breast MRI showing stages IIB to IIIC (2017 AJCC 8th edition staging);

Clinical staging confirmed by chest MRI and/or axillary ultrasound, as well as CT scans of the neck, abdomen, and pelvis, and bone scintigraphy, including T and N staging and assessment of distant metastasis;

Karnofsky performance score ≥80 or ECOG performance status of 0-1;

Disqualifiers

History of malignancy at other sites, excluding curable non-melanoma skin cancer and carcinoma in situ of the cervix;

Inability to complete MRI;

Inflammatory breast cancer;

Bilateral or multifocal primary tumors;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative SBRT for the Primary Lesion of Breast Cancer

    Radiation

    SBRT for Primary Lesion of Breast Cancer, Radiation Dose: Primary Lesion ≤3 cm, GTV 24Gy/3F; Primary Lesion \>3 cm, GTV 30Gy/5F.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant Chemoradiotherapy GroupExperimental treatment 1 intervention
Group B: Neoadjuvant Chemotherapy GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

pCR

Pathological Complete Response Following Surgery

Time frame
From enrollment to one month after surgery

Secondary outcomes

1

Breast Conserving Surgery Rate

Comparison of Breast Conserving Surgery Rates Between the Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy Groups

Time frame
From enrollment to the completion of surgery
2

PFS

Comparison of 3-Year Progression-Free Survival (PFS) Between the Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy Groups

Time frame
From enrollment to the completion of the 3-year follow-up period
3

Adverse Event Incidence Rate

Comparison of Adverse Event Incidence Rates Between the Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy Groups

Time frame
From enrollment to the completion of the 3-year follow-up period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.