Breast Cancer
Conditions
Interventions
None listed
Sponsors
Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age at the time of obtaining written consent is 20 years or older 2. Histologically diagnosed invasive breast cancer 3. Stage I-III without distant metastasis, see below for eligibility criteria for each subtype 4. Planned, undergoing, or after surgery and standard definitive treatment Standard curative treatments include radiotherapy, chemotherapy, anti-HER2 therapy, immune checkpoint inhibitors, PARP inhibitors, CDK4/6 inhibitors, etc. Endocrine therapy is not considered. Treatment selection is based on the judgment of the attending physician in accordance with various guidelines. Patients with a high risk of recurrence who cannot be treated with standard systemic drug therapy for any reason, such as age or pre-existing conditions, are eligible if surgery has been performed. 5. Satisfy any definition of high risk of recurrence by subtype below i. ER positive/HER2 negative a. 4 or more lymph node metastases b. 1-3 lymph node metastases with either tumor diameter >=5 cm or histological grade >=3 or Ki-67 >=20% c. Remaining invasive cancer in the breast or axillary lymph nodes at the time of surgery if preoperative chemotherapy was performed d. Diagnosed as high risk of recurrence by polygene assay ii. HER2 positive a. Lymph node metastasis positive b. Tumor diameter >=2 cm c. Remaining invasive cancer in the breast or axillary lymph nodes after preoperative chemotherapy iii. ER/PgR/HER2 negative a. Lymph node metastasis positive b. Tumor diameter >=2 cm c. Remaining invasive cancer in the breast or axillary lymph nodes after preoperative chemotherapy
Exclusion criteria
Exclusion criteria: 1 More than 6 months have passed since the completion of radical treatment 2 Having multiple cancers (excludes carcinoma in situ of the skin other than malignant melanoma) 3. Pregnancy, history of organ transplantation, or other conditions that affect ctDNA analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ctDNA positive rate at 1-6 months after completion of definitive treatment | — |
Countries
Japan
Contacts
Public ContactMasahiro Takada
Graduate School of Medicine, Kyoto University Department of Breast Surgery
Outcome results
None listed