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Breast Cancer · 2026.10.11

Carbon Ion Therapy for Breast Cancer: Clinical Trial Eligibility for Stage 0–I Early Breast Cancer (Summary of QST Hospital Materials)

Overview of carbon ion therapy for breast cancer

Aiming for treatment without surgery, QST Hospital is conducting clinical trials of “carbon ion therapy instead of surgery” for stage 0–I early breast cancer. Currently, carbon ion therapy for breast cancer is provided only in clinical trials.

Clinical trial structure

Enrollment for “Breast I” (stage I, age 60+) closed in May 2020. “Breast II” (stage 0–I, age 20+) and “Breast III” (stage 0–I, age 50+) are listed as recruiting. In Breast II, adjuvant therapy such as breast X-ray irradiation and hormone therapy follows carbon ion therapy; in Breast III, hormone therapy follows.

Main eligibility for Breast II

Invasive or non-invasive ductal carcinoma confirmed by needle biopsy or similar, with a single lesion within 20 mm on MRI. There must be no extensive lymphovascular invasion or intraductal spread, no lymph node metastasis over 2 mm on sentinel node biopsy, and no distant metastasis. Women aged 20 or older with performance status (PS) 0–2 who give written consent.

Main eligibility for Breast III

Non-invasive or invasive ductal carcinoma (usual type) confirmed by biopsy, stage 0–I with a single lesion within 20 mm on MRI. For invasive ductal carcinoma, the subtype must be Luminal A. Women aged 50 or older with PS 0–2 who give written consent.

Main exclusion criteria

Serious complications that make treatment hard to tolerate; prior surgery, chemotherapy, hormone, or targeted therapy for cancer in the same breast; systemic drug therapy for another active cancer; tumor edge within 5 mm of the skin on MRI; prior radiotherapy to the same area; pregnancy (Breast II); tumor invading the chest wall or skin (Breast III); and others. Participation is decided by the physician based on examination and test results.

Metastases from breast cancer

Lung metastases (up to 3), liver metastases (up to 3), and lymph node metastases (in principle, one nodal region) from breast cancer are eligible for Advanced Medical Care as metastatic tumors.

Notice on overseas patients

QST Hospital states that it does not accept breast cancer patients from overseas. Original: "※The patients from overseas with breast cancer and esophageal cancer are not accepted.Please contact us for details"

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Breast cancer resources other than carbon ion therapy: IVR (Interventional Radiology)

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Source: QST Hospital (Chiba, Japan), public materials 「乳がん|重粒子線治療の適応」 https://hospital.qst.go.jp/patients/indications/14.html (accessed 2026.10.11, summarized). Treatment outcome figures, case reports, and cost information were excluded in consideration of medical advertising regulations. Eligibility for treatment is determined by the physicians of the medical institution.