ocal treatment in addition to endocrine therapy in ER-positive/HER2-negative oligo-metastatic breast cancer : a multicentre, single –arm, phase 2 trial

Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 110 人开始时间: 待定最近更新: 2021年1月28日

试验速览

暂无简介。

•Age: = 19 years
•- Sex: Female
•- ER- positive/HER2-negative breast cancer patients, who were diagnosed with metastatic recurrence after primary treatment(surgery +/-, radiotherapy, neoadjuvant or adjuvant chemotherapy, adjuvant hormone therapy) for more than one year.
•- Oligometastases: = 2 lesions in single organ or site (lung, bone, liver, adrenal glands, distant LNs)
•- If the metastatic lesion count is different in patients who have performed two or more imaging test, more will be the result of the suspected imaging.
•- Metastatic lesions are up to 3 cm or less.
•- Lung : lesion within one side
•- Liver: lesion within single lobe
•- Lymph node : lesion with no more than two metastatic lymph node as mediastinum or opposite axilla, supraclavicular node and neck.
•Confirmed by a biopsy
•Two or more imaging test suspect metastasis
•- Metastatic lesions are feasible for loco-regional therapy (resection, radiotherapy, or radiofrequency ablation) (size=3cm)
•- Patients who are able to communicate without problems with obtaining consent related to the clinical trial

•- Excludes patients who have any of the following criteria:
•- Multiple metastatis (3 or more metastatic lesions within a single organ, 2 or more metastatic organs)
•- In case local treatment(resection, radiotherapy, or radiofrequency ablation) is not possible even if there are two or fewer lesions within a organ
•- Patients with other primary cancer (except thyroid cancer and melanoma)
•- Pregnancy and lactating women
•- Unable to read consent form (ex:illiterate, foreigner etc.)

发起方

Yonsei University Health System, Gangnam Severance Hospital