RecruitingPhase 3NCT06135714

Metastasis-directed Therapy for Oligometastases of Breast Cancer

a Randomized Trial for OLIGo Metastases Breast cAncer With or Without Metastasis-dIrected Therapy

Sponsor

Tokyo Medical and Dental University

Enrollment

340 participants

Start Date

Nov 8, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic Breast Cancer Oligometastasis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a treatment strategy for breast cancer that has spread to only a small number of sites in the body (called oligometastatic disease — up to 3 metastases). After initial systemic drug treatment, patients whose cancer is stable may receive targeted radiation or surgery to the remaining tumor spots. The goal is to see if this aggressive local treatment can improve long-term outcomes. **You may be eligible if...** - You are 18 to 80 years old with a confirmed diagnosis of invasive breast cancer with 1 to 3 metastases - Each metastasis is 3 cm or smaller - You are in generally good health (ECOG 0 or 1) - Local treatment (radiation or surgery) is feasible for all your metastatic sites - You have not previously received treatment specifically aimed at the metastases **You may NOT be eligible if...** - You have more than 3 metastatic sites - You are pregnant or breastfeeding - You have poorly controlled diabetes, high blood pressure, or heart failure - You have interstitial lung disease or pulmonary fibrosis - You have active hepatitis B Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSystemic therapy for 12 weeks after primary registration

* Luminal BC 1. Denovo stage IV Premenopausal(PRE): Aromatase inhibitor(AI) + CDK4/6 inhibitor(CDK) +LHRH agonist, or Fulvestrant(FUL) + CDK4/6 inhibitor +LHRH agonist Postmenopausal(POST): AI + CDK 2. Recurrence after completion of postoperative endocrine therapy PRE: AI + CDK +LHRH agonist, or FUL + CDK +LHRH agonist POST: AI + CDK, or FUL + CDK 3. Recurrence during postoperative endocrine therapy PRE: FUL + CDK +LHRH agonist, or AI + CDK +LHRH agonist POST: FUL + CDK * HER2-positive BC Pertuzumab + Trastuzumab + Taxane (docetaxel or paclitaxel) ・Triple negative BC. 1. PD-L1 negative - following a) or b) 1. Taxane (naive for taxane) 2. S-1 or Capecitabine or Eriblin (previously treated with taxane) 2. PD-L1 positive - following a) or b) 1. Pembrolizumab + Gemcitabine + Carboplatin 2. Atezolizumab + Nab-paclitaxel 3. BRCA-mutation positive Olaparib

PROCEDURERadiation therapy (SBRT/conventional RT)

Brain: 18-24Gy/1Fr. or 27Gy/3Fr. or 30Gy/5Fr. Lung: 42Gy/4Fr.(peripheral) or 50Gy/8Fr.(central) or 60Gy/25Fr.(ultra central) Liver/Adrenal: 40Gy/5Fr. Bone: 35Gy/5Fr. Distant lymph node: 45/10Fr. or 60Gy/25Fr.

PROCEDURESurgery

Surgery for the oligometastases

DRUGSame systemic therapy after secondary registration

Locations(1)

Tokyo Medical and Dental Univetsity

Tokyo, Tokyo, Japan

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NCT06135714

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