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NCT Number: NCT06697938

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Junjie Li, PhD

PRINCIPAL_INVESTIGATOR

Qian Peng, PhD

CONTACT

[email protected]

Qian Peng, PhD

PRINCIPAL_INVESTIGATOR

Rui Li, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. pCR

    Time frame: From enrollment to one month after surgery

    Pathological Complete Response Following Surgery

Secondary outcomes

  1. Breast Conserving Surgery Rate

    Time frame: From enrollment to the completion of surgery

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

  2. PFS

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

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

  3. Adverse Event Incidence Rate

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Peng, Phd

CONTACT

[email protected]

86-028-85420059

Rui Li, MD

CONTACT

[email protected]

86-028-85420590

Sponsors and collaborators

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Other

Registry information

Acronym: NCRT-LABC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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