Personalized local treatment for breast cancer with involved supraclavicular or internal mammary lymph nodes
A Prospective Phase II Clinical Study of Response-Based Local Therapy After Systemic Therapy in Regionally Advanced Breast Cancer
This trial tests a personalized plan of shorter-course radiotherapy with a targeted boost, surgery when needed, and tailored extra systemic therapy to see if it improves progression-free survival for adults whose breast cancer involves nearby supraclavicular or internal mammary lymph nodes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 157 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07376538 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adult women aged 18–75 with newly diagnosed invasive breast cancer and pathologically or imaging-confirmed ipsilateral supraclavicular and/or internal mammary lymph node involvement who are fit for neoadjuvant therapy, surgery, and radiotherapy are the intended participants.
Not a fit: Patients without regional nodal involvement, with distant metastatic disease, with poor performance status or major comorbidities, or who cannot travel to or undergo the planned treatments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve how long patients remain free of disease and personalize local and systemic treatments to each patient's response and tumor subtype.
How similar studies have performed: Elements such as hypofractionated radiotherapy and subtype-tailored systemic therapy have supporting data, but combining response-adapted local boosts and selective nodal surgery in this specific regional-node population is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.