A phase I/II clinical trial of radical radiotherapy using carbon-ion beams for early breast cancer - Breast Cancer I

Karasawa Kumiko0 sites20 target enrollmentFebruary 25, 2019

Overview

No summary available.

Registry

who.int

Start Date

February 25, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

Karasawa Kumiko

•1\. Biopsy\- or histology\-proven invasive ductal carcinoma of the breast (usual type)
•2\. A single tumor with an extent of less than 2 cm on MRI (Stage I disease in UICC)
•3\. No extensive lymphatic infiltration (LVSI), no extensive intraductal extension (EIC). Estrogen receptor (ER) positive and HER2\-negative.
•4\. PS is 0\-2\.
•5\. A woman age of 60 or over.
•6\. Expected to survive for more than 6 months.
•7\. The person wishes to participate in the exam and has obtained written consent.

•1\. Have serious uncontrollable complications (eg, uncontrollable cardiopulmonary disease, intractable infections, uncontrollable psychiatric disorders, etc.).
•2\. Has a history of treatment such as surgery, chemotherapy, endocrine therapy, and molecular\-targeted drugs for ipsilateral breast cancer.
•3\. Systemic drug therapy for active cancers (including contralateral breast cancer).
•4\. Tumor infiltrates chest wall or skin.
•5\. The distance between the tumor and the skin, including the intraductal extension that can be identified on the MRI image, is within 5 mm.
•6\. There is a history of radiation therapy at the tumor site.
•7\. Ductal carcinoma in situ (pure DCIS).
•8\. The attending physician considers it inappropriate due to medical, psychological or other factors.