Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06404697

Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients

Led by Ruijin Hospital · Updated on 2024-05-08

24

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

cN3c breast cancer with ipsilateral supraclavicular (SCV) lymph nodal (SCLN) metastasis is known to have a dismal prognosis. Currently, the combined-modality therapy consisting of primary systemic therapy (PST), subsequent local and/or systemic therapy based on response is the standard of care. However, the value of giving radiotherapy (RT) boost to SCV region remains uncertain in cN3c patients. This study aimed to assess the efficacy and safety of RT boost to the SCV area in high-risk cN3c breast cancer patients based on nodal response following PST.

CONDITIONS

Official Title

Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation with documented informed consent.
  • Female aged 18 years or older.
  • Histological or cytological confirmed primary breast carcinoma.
  • Clinical diagnosis of cN3c.
  • Received neoadjuvant therapy as guided by physician and guidelines.
  • Did not achieve complete clinical response (cCR) in supraclavicular lymph nodes after neoadjuvant therapy.
  • Undergoing curative-intent breast cancer surgery after neoadjuvant therapy.
  • Pathological evaluation of axillary lymph nodes after surgery.
  • Karnofsky Performance Status (KPS) score of 80 or higher, with expected survival over 2 years.
  • Complete healing of surgical incision without complications.
  • Negative pathological surgical margins.
  • Available hormone receptor (ER/PR), HER2, and Ki-67 status for primary tumor.
  • Premenopausal females must use contraception for at least one month before screening, during the study, and for a specified time after ending the study.
Not Eligible

You will not qualify if you...

  • Confirmed distant metastases by pathology or imaging.
  • No neoadjuvant systemic therapy received.
  • No curative-intent surgery performed.
  • Pregnant or breastfeeding women.
  • Severe non-cancer illnesses preventing radiotherapy.
  • History of other cancers within 5 years except certain in situ cancers.
  • Simultaneous cancer in the opposite breast.
  • Prior radiation therapy to neck, chest, or same side axilla.
  • Active collagen vascular disease.
  • Primary tumor staged as T4.
  • Unable to start radiotherapy within 12 weeks after breast cancer surgery or within 8 weeks after completing adjuvant chemotherapy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

S

Shuyan Li, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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