Neoadjuvant Chemotherapy Combined With Preoperative Radiotherapy for Locally Advanced Breast Cancer

NCT07164872 | Not Yet Recruiting

• 1 other identifier: JS2025-6-1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Approximately 20% of breast cancer patients in our country are in the locally advanced stage. The relatively low overall survival rate, high recurrence rate and distant metastasis risk of these patients significantly affect the therapeutic efficacy and survival. Preoperative radiotherapy is a treatment option for many tumors. It is recommended to administer radiotherapy and systemic chemotherapy before surgery to enhance preoperative tumor downstaging, eliminate micrometastatic lesions and improve overall survival rate. Preoperative radiotherapy combined with chemotherapy for breast cancer patients further shrinks the tumor, increases the probability of breast preservation, and may also eliminate the need for axillary lymph node dissection, thereby improving the quality of life of patients. Pathological complete response (pCR) not only helps with subsequent surgery but also has significant advantages in improving survival rate. Neoadjuvant radiotherapy is also one of the treatment options for reducing tumor stage, but it has not been widely applied to breast cancer patients. Among breast cancer subtypes, Luminal type accounts for 50-70%, among which HR+ HER2- breast cancer patients have poor efficacy from neoadjuvant chemotherapy and pCR rate is below 5-10%. Triple-negative breast cancer accounts for 15-20% of all breast cancer subtypes. It has the characteristics of poor differentiation, strong invasiveness, earlier and more frequent recurrence and metastasis. The efficacy of traditional neoadjuvant chemotherapy has approached its limit. This study aims to explore the efficacy and safety of neoadjuvant radiotherapy for locally advanced breast cancer.

Conditions

Breast Cancer

Keywords

breast cancer; preoperative radiotherapy; pCR

Outcome Measures

Primary Outcomes (1)

• pathological complete respons

  pathological complete

  8-12 weeks

Study Arms (1)

preoperative radiotherapy

EXPERIMENTAL

whole breast irradiation of the affected side ± chest wall + regional lymph node drainage area irradiation: whole breast ± chest wall + supraclavicular and internal mammary regional lymph node drainage area 40.05Gy/152.67Gy/ day per session, axillary regional lymph node drainage area 37.5Gy/15f,2.5Gy/ per session

Radiation: preoperative radiotherapy

Interventions

preoperative radiotherapy RADIATION

preoperative radiotherapy

preoperative radiotherapy

Eligibility Criteria

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

You may qualify if:

• The pathological diagnosis was invasive breast cancer.
• cT3-4, cN1-2, M0 (according to the 8th edition of the AJCC Cancer Staging Manual), molecular typing is Luminal type (HER2-) or triple-negative type. The volume of the primary lesion did not decrease by more than 50% after 2 cycles of neoadjuvant chemotherapy.
• Generally in good condition (KPS score \> 70), organ functions are tolerable, and there are no severe complications due to poor control.
• Acceptable for magnetic resonance imaging scan
• Have the conditions for follow-up
• Sign the informed consent form

You may not qualify if:

• gestation period
• Simultaneous bilateral breast cancer
• History of chest wall radiotherapy
• Active connective tissue disease
• Inflammatory breast cancer
• Excessive breast volume (\>600ml), BMI \> 30
• diabetes
• Positive lymph nodes in the upper and lower regions of the clavicle and the internal mammary region
• Using immunotherapy drugs such as PD-1/PD-L1

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jing Jin

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yutong Tan

CONTACT

+86-18674776996; yttan1231@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share