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Metastasis-directed Therapy for Oligometastases of Breast Cancer

ConditionsBreast CancerOligometastasisMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTokyo Medical and Dental University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically diagnosed as invasive breast cancer. Biopsy from oligometastasis is desirable but not required.

Histologically proven positive/negative for ER, PgR, and HER2, and classified as luminal, HER2-positive, or TN breast cancer.

One of the following <1> to <4>; <1>In case of no history of breast cancer in the past, either (i) or (ii) below.

Diagnosed with advanced breast cancer with oligometastasis by neck to pelvis enhanced CT, FDG-PET (PET/CT), and brain enhanced MRI.

Disqualifiers

Active malignancies curatively treated with no evidence of disease for >= 5 years prior to randomization.

Infection with care.

Fever up 38 degrees Celsius.

Childbearing potential, delivery after 28 days, breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Systemic therapy for 12 weeks after primary registration

    Drug

    * 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

  • Radiation therapy (SBRT/conventional RT)

    Procedure/Surgery

    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.

  • Surgery

    Procedure/Surgery

    Surgery for the oligometastases

  • Same systemic therapy after secondary registration

    Drug

    * 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

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Arm A: Standard of carePlacebo comparator 2 interventions
Group B: Arm B: Metastasis-directed therapy followed by Standard of careExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall survival after second registration

Time frame
5 years

Secondary outcomes

1

Overall survival after primary registration

Time frame
5 years
2

Progression-free survival

Time frame
5 years
3

Progression site (oligometastasis, lesion other than oligometastasis)

Time frame
5 years
4

Oligometastatic progression-free survival for each definitive local therapy (group B only)

Time frame
5 years

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Institute of Science TokyoRecruiting113-8510, Bunkyō-Ku, TokyoJapanJapan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tokyo Medical and Dental University

Lead sponsor

Institute of Science Tokyo Hospital

Sponsor institution

Source ClinicalTrials.gov
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