A randomized controlled trial of metastasis-directed therapy for oligometastases in breast cancer: OLIGAMI trial (JCOG2110)

Oligometastasis is a concept that refers to the condition between localized cancer and widespread distant metastases; however, a consensus on the definition has yet to be reached. Metastasis-directed therapy (MDT) has recently been established to incorporate local therapy, such as radiotherapy and surgery, for distant metastases. Previous trials have proposed the possibility of long-term survival with the administration of MDT for patients with oligometastases. However, the efficacy and safety of MDT have not been sufficiently validated. We are conducting this clinical trial to confirm the superiority of MDT combined with subtype-specific systemic drug therapy over systemic drug therapy alone in patients with oligometastatic breast cancer. Here, "oligometastases" are defined as tumors with a maximum diameter ≤ 3 cm and total number ≤ 3. The primary endpoint is overall survival. We intend to enroll 340 patients from 62 institutions over a 3-year period. This trial has been registered in the Japan Registry of Clinical Trials (jRCTs031230439).

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Publication Details

Journal
Japanese Journal of Clinical Oncology
Published
2026-01-20
DOI
https://doi.org/10.1093/jjco/hyag019
Primary Topic
Cancer Research and Treatments
Type
article
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article

A randomized controlled trial of metastasis-directed therapy for oligometastases in breast cancer: OLIGAMI trial (JCOG2110)

Keita Sasaki, Taro Shibata, T. Mizowaki, Yasuaki Sagara et al.
Japanese Journal of Clinical Oncology
Cancer Research and Treatments
article

A randomized controlled trial of metastasis-directed therapy for oligometastases in breast cancer: OLIGAMI trial (JCOG2110)

Keita Sasaki, Taro Shibata, T. Mizowaki, Yasuaki Sagara, Ikuno Nishibuchi, Kaori Terata, D. Kawahara, Tadahiko Shien, Kazuki Sudo, Ryunosuke Machida, Toshiyuki Ishiba, Yuta Sekino, Naoto Shikama, Sakai Takehiko, Michio Yoshimura, Yoichi Naito, Fumikata Hara, Kazuki Nozawa, Akihiko Shimomura, Yukinori Ozaki
article en

Abstract

Oligometastasis is a concept that refers to the condition between localized cancer and widespread distant metastases; however, a consensus on the definition has yet to be reached. Metastasis-directed therapy (MDT) has recently been established to incorporate local therapy, such as radiotherapy and surgery, for distant metastases. Previous trials have proposed the possibility of long-term survival with the administration of MDT for patients with oligometastases. However, the efficacy and safety of MDT have not been sufficiently validated. We are conducting this clinical trial to confirm the superiority of MDT combined with subtype-specific systemic drug therapy over systemic drug therapy alone in patients with oligometastatic breast cancer. Here, "oligometastases" are defined as tumors with a maximum diameter ≤ 3 cm and total number ≤ 3. The primary endpoint is overall survival. We intend to enroll 340 patients from 62 institutions over a 3-year period. This trial has been registered in the Japan Registry of Clinical Trials (jRCTs031230439).

Japanese Journal of Clinical Oncology
Hiroshima University (JP), Akita University (JP), Kyoto University (JP), Nagoya City University (JP), Juntendo University (JP), National Cancer Center (US), National Center for Global Health and Medicine (JP), Okayama University Hospital (JP), University of Tokyo Hospital (JP), Kagoshima University Hospital (JP), Akita University Hospital (JP), Aichi Cancer Center (JP), National Cancer Center Hospital East (JP), Kyoto University Hospital (JP), Japan Clinical Cancer Research Organization (JP), Japanese Foundation For Cancer Research (JP), National Cancer Research Institute (GB)
Good health and well-being
Openalex Percentile: Top 73%
Cancer Research and Treatments
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