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

NCT06697938 | Recruiting DMC

• 1 other identifier: SCCSMC-01-2024-034
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

locally advanced breast cancer; neoadjuvant radiotherapy

Outcome Measures

Primary Outcomes (1)

• pCR

  Pathological Complete Response Following Surgery

  From enrollment to one month after surgery

Secondary Outcomes (3)

• Breast Conserving Surgery Rate

  From enrollment to the completion of surgery

• PFS

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

• Adverse Event Incidence Rate

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

Study Arms (2)

Neoadjuvant Chemoradiotherapy Group

EXPERIMENTAL

Preoperative umor SBRT and surgery after Neoadjuvant Chemotherapy

Radiation: Preoperative SBRT for the Primary Lesion of Breast Cancer

Neoadjuvant Chemotherapy Group

NO INTERVENTION

Surgery after Neoadjuvant Chemotherapy

Interventions

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.

Neoadjuvant Chemoradiotherapy Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (22)

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  BACKGROUND

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Qian Peng, Phd

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

• Junjie Li, Phd

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Peng, Phd

CONTACT

86-028-85420059; pengqian@scszlyy.org.cn

Rui Li, MD

CONTACT

86-028-85420590; lirui1@scszlyy.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Abdominal Radiotherapy, Ward 1

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)