乳がんの少数転移に対する転移標的療法

基本情報

NCT ID: NCT06135714
ステータス: 募集中
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 340
治験依頼者名: Tokyo Medical and Dental University

概要

OLIGAMI trial is a multi-institutional, two-arm, open-label, randomized controlled phase III trial being conducted with the participation of 50 hospitals belonging to Japan Clinical Oncology Group. After the first registration, all patients will be performed in a 12-week, subtype-specific, systemic therapy consisting of CDK4/6 inhibitors with hormonal therapy for luminal BC, docetaxel with trastuzumab and pertuzumab for HER2-positive BC, chemotherapy with immune checkpoint inhibitors for triple-negativeBC expressing PD-L1, and olaparib for cases harboring BRCA mutations. For other triple-negative BC, chemotherapy will be administered. If this 12-week systemic therapy does not cause any progression or complete response, patients proceed to second registration for randomization; arm A continues same systemic therapy alone, and arm B performs MDT followed by same systemic therapy. The MDT will involve either RT or surgery, and RT will involve mainly SBRT and partly conventional RT.

対象疾患

Breast CancerOligometastasisMetastatic Breast Cancer

介入

Systemic therapy for 12 weeks after primary registration(DRUG)

Radiation therapy (SBRT/conventional RT)(PROCEDURE)

Surgery(PROCEDURE)

Same systemic therapy after secondary registration(DRUG)

依頼者（Sponsor）

Tokyo Medical And Dental University(OTHER)

実施施設 (1)

東京歯科大学水道橋病院

Tokyo, Tokyo, Japan(RECRUITING)