RecruitingNot ApplicableNCT06697938

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


Sponsor

Sichuan Cancer Hospital and Research Institute

Enrollment

148 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

  • 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;
  • No history of allergies to doxorubicin, cyclophosphamide, paclitaxel/docetaxel;
  • No prior exposure to radiotherapy, chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.

Exclusion Criteria5

  • 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;
  • Active infection currently present; clinically evident heart disease; myocardial infarction or cerebrovascular accident within 6 months prior to enrollment.

Interventions

RADIATIONPreoperative SBRT for the Primary Lesion of Breast Cancer

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


Locations(1)

Sichuan Cancer Hospital

Chengdu, Sichuan, China

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NCT06697938


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