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Local treatment in addition to endocrine therapy in ER-positive/HER2-negative oligo-metastatic breast cancer

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0003767
Enrollment
110
Registered
2019-04-15
Start date
2019-05-30
Completion date
Unknown
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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.)

Design outcomes

Primary

MeasureTime frame
Progression free survival

Secondary

MeasureTime frame
Overall survival

Countries

Korea, Republic of

Contacts

Public ContactSung Gwe Ahn

Yonsei University Health System, Gangnam Severance Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026