Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients
Recruiting · NCT06404697 · Interventional (participants receive a specific treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Boost irradiation
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Voluntary participation with documented informed consent.
- Females aged ≥18 years.
- Histological or cytological confirmed primary breast carcinoma.
- Clinical diagnosis of cN3c.
- Receipt of neoadjuvant therapy, guided by the attending physician and current treatment guidelines.
- Did not achieve cCR in SCLN following neoadjuvant therapy.
- Undergoing curative-intent breast cancer surgery post-neoadjuvant therapy.
- Pathological evaluation of axillary lymph nodes post-surgery.
- KPS score ≥80, with expected survival exceeding 2 years.
- Complete healing of surgical incision without complications.
- Negative pathological surgical margins.
- Availability of hormonal receptor (ER/PR), HER2, and Ki-67 status for the primary breast lesion.
- Pre-menopausal females required to practice contraception for at least one month prior to screening, maintaining contraception throughout the study and for a specified period post-study cessation.
Exclusion criteria
- Patients with confirmed distant metastases by pathology or imaging.
- Those who have not received neoadjuvant systemic therapy.
- Patients who have not undergone curative-intent surgery.
- Pregnant or lactating women.
- Individuals with severe non-neoplastic comorbidities affecting radiotherapy implementation.
- History of malignancy within the past 5 years (excluding ductal carcinoma in situ, basal cell carcinoma, squamous cell carcinoma in situ, cervical carcinoma in situ, and in situ adenocarcinoma of the lung).
- Simultaneous contralateral breast cancer.
- History of prior radiation therapy to the neck, chest, or ipsilateral axilla.
- Active collagen vascular disease.
- Patients with T4 staging of the primary tumor.
- Inability to initiate radiotherapy within 12 weeks post breast cancer curative surgery (breast-conserving surgery or mastectomy), or within 8 weeks post completion of adjuvant chemotherapy.
Where it is running
1 location listed.
- Ruijin hospital, Shanghai jiaotong university school of medicine - Shanghai, Shanghai Municipality, China