NCT06135714 - Metastasis-directed Therapy for Oligometastases of Breast Cancer | Biotech Hunter

Enrollment

340

Participants

Timeline

Start Date

November 8, 2023

Primary Completion Date

November 8, 2026

Study Completion Date

October 31, 2032

Conditions

Breast CancerOligometastasisMetastatic Breast Cancer

Interventions

DRUG

Systemic 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"

PROCEDURE

Radiation 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.

PROCEDURE

Surgery

Surgery for the oligometastases

DRUG

Same systemic therapy after secondary 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"

Trial Locations (1)

1138510

RECRUITING

Tokyo Medical and Dental Univetsity, Tokyo