Status:

NOT_YET_RECRUITING

Neoadjuvant Chemotherapy Combined With Preoperative Radiotherapy for Locally Advanced Breast Cancer

Lead Sponsor:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-70 years

Phase:

NA

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 patien...

Detailed Description

Approximately one fifth of the patients in China have non-metastatic locally advanced breast cancer. Due to their relatively low overall survival rate, high recurrence rate, and risk of distant metast...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2032

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07164872

Start Date

October 1 2025

End Date

December 31 2032

Last Update

September 10 2025

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