Personalized local treatment for breast cancer with involved supraclavicular or internal mammary lymph nodes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-center interventional trial enrolls adult women with histologically confirmed breast cancer and positive ipsilateral supraclavicular and/or internal mammary lymph nodes who are planned for neoadjuvant systemic therapy followed by surgery. Treatment is response-adapted: hypofractionated radiotherapy with a local boost is adjusted based on response to neoadjuvant treatment, selected patients with high residual nodal tumor burden may undergo local lymph node surgery, and systemic consolidation therapy is intensified and tailored by molecular subtype. The trial measures progression-free survival and safety outcomes to determine whether the combined, individualized approach improves disease control. Eligibility requires ECOG ≤ 2 and adequate organ function, and all treatment and follow-up occur at the Cancer Hospital, Chinese Academy of Medical Sciences in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Female patients aged 18 to 75 years.

ECOG performance status ≤ 2.

Histologically confirmed invasive breast cancer.

Newly diagnosed breast cancer with pathologically confirmed positive ipsilateral supraclavicular lymph nodes (ISLN) and/or internal mammary lymph nodes (IMLN); for patients in whom IMLN biopsy is not feasible, clinically positive IMLN based on investigator assessment and imaging findings is acceptable.

Planned to receive neoadjuvant systemic therapy followed by breast-conserving surgery or mastectomy and axillary lymph node dissection, with or without supraclavicular and/or internal mammary lymph node dissection.

Adequate baseline organ function, defined as: absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 9 g/dL (90 g/L); serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min; total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN; INR ≤ 1.5 and PT/APTT ≤ 1.5 × ULN.

Able and willing to comply with study procedures and scheduled follow-up.

Written informed consent obtained prior to any study-related procedures.

Exclusion Criteria:

Evidence of distant metastatic disease.

Presence of severe or uncontrolled concomitant diseases, including severe cardiac dysfunction; myocardial infarction, uncontrolled arrhythmia, or unstable angina within 3 months prior to enrollment; clinically significant pericardial disease; or severe pulmonary disease.

Prior radiotherapy to the chest wall or supraclavicular region.

Pregnancy, lactation, or any condition considered by the investigator to contraindicate radiotherapy.

History of or concurrent second primary malignancy, except for non-melanoma skin cancer, papillary or follicular thyroid carcinoma, carcinoma in situ of the cervix, contralateral non-invasive breast cancer, or other malignancies treated with curative intent with no evidence of disease for more than 3 years.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.