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

NCT ID: NCT06697938

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2027-07-31

Brief 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.

Detailed Description

Breast cancer is a tumor with high tumor heterogeneity, and treatment outcomes vary significantly across different molecular subtypes. In recent years, the emergence of novel treatment methods has significantly improved the overall survival and progression-free survival of patients with early-stage, especially metastatic tumors. However, a portion of patients with locally advanced breast cancer (LABC) still have poor prognoses. As early as the 1970s, preoperative radiotherapy was applied to locally advanced breast cancer to increase resectability, but due to limitations in radiotherapy techniques and other factors, preoperative radiotherapy increased the incidence of acute toxic reactions and postoperative complications. Compared to traditional postoperative radiotherapy, neoadjuvant radiotherapy has several theoretical advantages, such as more precise tumor target localization, optimization of breast reconstruction radiotherapy strategies, increased tumor downstaging to improve breast-conserving surgery opportunities, and improved pathological complete response rates, potentially eliminating the need for breast surgery. With the advent of the era of precision radiotherapy, modern radiotherapy technologies have provided solutions to reduce the acute toxic reactions associated with preoperative radiotherapy. This study focuses on preoperative treatment modalities for luminal-type locally advanced breast cancer. 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 these patients. The goal is to provide new strategic options for the preoperative treatment of luminal-type locally advanced breast cancer.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant Chemoradiotherapy Group

Preoperative umor SBRT and surgery after Neoadjuvant Chemotherapy

Group Type: EXPERIMENTAL

Preoperative SBRT for the Primary Lesion of Breast Cancer

Intervention Type: RADIATION

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

Neoadjuvant Chemotherapy Group

Surgery after Neoadjuvant Chemotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Preoperative 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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Pathologically confirmed invasive breast cancer ;

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

3. 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;

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

5. No history of allergies to doxorubicin, cyclophosphamide, paclitaxel/docetaxel;

6. No prior exposure to radiotherapy, chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.

Exclusion Criteria

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

2. Inability to complete MRI;

3. Inflammatory breast cancer;

4. Bilateral or multifocal primary tumors;

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Qian Peng

Director of the Department of Abdominal Radiotherapy, Ward 1

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qian Peng, Phd

Role: PRINCIPAL_INVESTIGATOR

Sichuan Cancer Hospital and Research Institute

Junjie Li, Phd

Role: PRINCIPAL_INVESTIGATOR

Sichuan Cancer Hospital and Research Institute

Locations

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qian Peng, Phd

Role: CONTACT

pengqian@scszlyy.org.cn

86-028-85420059

Rui Li, MD

Role: CONTACT

lirui1@scszlyy.org.cn

86-028-85420590

Facility Contacts

Qian Peng, PhD

Role: primary

pengqian@scszlyy.org.cn

Rui Li, MD

Role: backup

lirui1@scszlyy.org.cn

Qian Peng, PhD

Role: backup

Junjie Li, PhD

Role: backup

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Other Identifiers

SCCSMC-01-2024-034

Identifier Type: -

Identifier Source: org_study_id