Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06135714
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2023-11-13
Brief Title:
Metastasis-directed Therapy for Oligometastases of Breast Cancer
Sponsor:
Tokyo Medical and Dental University
Organization:
Tokyo Medical and Dental University
Study Overview
Official Title:
a Randomized Trial for OLIGo Metastases Breast cAncer With or Without Metastasis-dIrected Therapy
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OLIGAMI
Brief 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 CDK46 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
Detailed Description:
A brief background discussion Oligometastases were initially described as a concept bridging localized disease with widespread distant metastases but a consensus on its definition has yet to be reached Recently the term metastasis-directed therapy MDT was coined to encompass local therapy for distant metastases including surgery and radiation therapy RT especially stereotactic body radiation therapy SBRT Though OLIGO-BC1 and SABR-COMET have indicated the potential benefits of MDT for oligometastases NRG-BR002 revealed no significant difference in progression-free survival PFS As a definitive conclusion to this clinical question has not been reached there is an increasing demand for phase III trials focusing on breast cancer BC We planned the JCOG2110 also called as OLIGAMI trial Trial design 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 CDK46 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 OLIGAMI trial will encompass all subtypes of advanced BC The key criteria of the first registration are as follows 1 Histologically diagnosed as invasive BC Biopsy from oligometastases is desirable but not required 2 Diagnosed with advanced BC with oligometastases by neck to pelvis enhanced CT FDG-PETand brain enhanced MRI 3 Oligometastases defined as i Maximum diameter of each tumor is 3 cm or less ii Total number of 3 or less iii In case of brain metastasis maximum diameter is 2 cm or less and asymptomatic 4 The patient with local recurrence is included 5 De novo stage IV BC is included The criteria of secondary registration are as follows 1 The planned number of courses of systemic therapy has been performed 2 No progression or new distant metastasis by response evaluation 3 At least one oligometastasis remains Specific Aims OLIGAMI trial aims to confirm the superiority of MDT to systemic therapy for oligometastases of BC The primary endpoint is overall survival OS after randomization while the secondary endpoints include OS after first registration PFS progression site oligometastases vs non-oligometastases PFS specifically related to MDT restricted arm B proportion of adverse events and serious adverse events and the non-progression proportion of health-related quality of life Statistical methods The sample size was calculated as 268 to detect 12 of 5-year OS difference with a one-sided alpha of 005 power of 70 3 years of accrual and 5 years of follow up Therefore we assumed the planned sample size for second registration for randomization as 270 We set the number of first registration as 340 assuming that there may be some patients with progression or complete response after the systemic therapy for 12 weeks Present accrual and target accrual The patient accrual will start in November 2023 Enrolment of 340 patients for first registration is planned over a 3-year accrual period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None