NCT02743910Not reportedCompletedBreast Monitoring Plasma Tumor DNA in Early-Stage Breast Cancer
Observational study of up to 229 people with newly diagnosed stage II-III invasive HER2-positive or triple-negative breast cancer planned for neoadjuvant therapy. The registry primary outcome is correlation of absent plasma tumor DNA with pathologic complete response. ClinicalTrials.gov lists the study as completed and does not assign a phase. Meeting reports refer to this record as PREDICT-DNA (TBCRC 040).
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
NCT03145961Phase 2UnknownBreast c-TRAK TN: ctDNA surveillance to trigger pembrolizumab in early triple-negative breast cancer
Phase 2 trial that uses serial ctDNA to detect residual disease after primary treatment for moderate- or high-risk early triple-negative breast cancer and to start pembrolizumab. ClinicalTrials.gov lists the status as unknown.
Institute of Cancer Research, United Kingdom
NCT04434040Phase 2RecruitingBreast Atezolizumab plus sacituzumab govitecan to prevent recurrence in TNBC (ASPRIA)
Phase 2 trial of atezolizumab plus sacituzumab govitecan for six cycles in triple-negative breast cancer. The registry primary outcome is the rate of undetectable circulating tumor cell-free DNA. ClinicalTrials.gov lists the study as recruiting.
Dana-Farber Cancer Institute
NCT04768426Phase 2RecruitingBreast Serial ctDNA monitoring during adjuvant capecitabine in early triple-negative breast cancer
Phase 2 trial of adjuvant capecitabine with serial ctDNA monitoring. The registry primary outcome is the baseline level of ctDNA detection. ClinicalTrials.gov lists the study as recruiting.
Stanford University
NCT04915755Phase 3Active, not recruitingBreast ZEST: niraparib versus placebo for ctDNA-positive breast cancer after definitive therapy
Phase 3 trial of niraparib versus placebo in patients with triple-negative or BRCA-mutated HER2-negative breast cancer who have ctDNA detected without radiographic recurrence. ClinicalTrials.gov lists the study as active, not recruiting, with 40 patients enrolled.
GlaxoSmithKline
NCT04985266Phase 2RecruitingBreast Early detection of molecular relapse with ctDNA tracking and treatment with palbociclib plus fulvestrant in ER-positive HER2-negative breast cancer
Phase 2 trial of ctDNA surveillance and, in the treatment phase, palbociclib plus fulvestrant versus standard endocrine therapy. Registry primary outcomes include the incidence of a positive ctDNA result and relapse-free survival. ClinicalTrials.gov lists the study as recruiting.
Royal Marsden NHS Foundation Trust
NCT05388149Phase 2RecruitingBreast Kadcyla and neratinib for interception of HER2-positive breast cancer with molecular residual disease
Phase 2 trial whose registry primary outcome is clearance of ctDNA, measured with the RaDaR assay, after neratinib is added to trastuzumab emtansine in people with detectable MRD. ClinicalTrials.gov lists the study as recruiting.
University Health Network, Toronto
NCT05770531Phase 2RecruitingBreast Circulating tumor DNA to guide changes in standard of care chemotherapy
Phase 2 trial in metastatic HER2-negative or triple-negative breast cancer whose title states that ctDNA is used to guide changes in chemotherapy. The registry primary outcome is progression-free survival. ClinicalTrials.gov lists the study as recruiting.
Vanderbilt-Ingram Cancer Center
NCT06517212Phase 2RecruitingBreast Tirzepatide weight loss for MRD-positive early breast cancer
Phase 2 trial of tirzepatide in early breast cancer with molecular residual disease. Registry primary outcomes are ctDNA efficacy and distant disease-free survival. ClinicalTrials.gov lists the study as recruiting.
Baylor Research Institute
NCT06643585Phase 3RecruitingBreast Trastuzumab deruxtecan versus standard therapy for molecular relapse in early breast cancer
Phase 3 randomized trial of trastuzumab deruxtecan versus standard therapy after molecular relapse. The registry primary outcome is the ctDNA clearance rate 12 months after randomization. ClinicalTrials.gov lists the study as recruiting.
Prof. Wolfgang Janni
NCT06970912Phase 2RecruitingBreast ctDNA-guided de-escalation of adjuvant chemotherapy with dalpiciclib in HR-positive HER2-negative breast cancer
Phase 2 trial titled as ctDNA-guided de-escalation. Registry primary outcomes are the ctDNA clearance rate after neoadjuvant therapy and 3-year event-free survival. ClinicalTrials.gov lists the study as recruiting.
Peking University People's Hospital
NCT07025785Not applicableRecruitingBreast Molecular residual disease assessment in early-stage breast cancer
Interventional study of postoperative ctDNA in lymph-node-positive early breast cancer. The registry lists the phase as not applicable and the primary outcome as the number of participants with postoperative ctDNA detected. ClinicalTrials.gov lists the study as recruiting.
UNC Lineberger Comprehensive Cancer Center
NCT07069595Phase 2RecruitingBreast PREDICT-RD: ctDNA surveillance in TNBC with residual disease
Phase 2 study in stage II or III triple-negative breast cancer with residual disease after neoadjuvant therapy. The registry primary outcome is the proportion with molecular residual disease. ClinicalTrials.gov lists the study as recruiting.
UNC Lineberger Comprehensive Cancer Center
NCT07191717Phase 2RecruitingBreast Imlunestrant and abemaciclib for estrogen receptor-positive breast cancer with minimal residual disease (MIRI)
Phase 2 trial of abemaciclib plus imlunestrant for up to 12 cycles. The registry primary outcome is the rate of ctDNA clearance. ClinicalTrials.gov lists the study as recruiting.
Jonsson Comprehensive Cancer Center
NCT07366112Phase 2RecruitingBreast CDK4/6 inhibitors with endocrine therapy as neoadjuvant treatment, with ctDNA-guided therapy after surgery
Phase 2 trial of neoadjuvant CDK4/6 inhibitor plus endocrine therapy. The registry says post-surgery treatment is guided by ctDNA status, and the primary outcome is the ctDNA clearance rate after neoadjuvant therapy. ClinicalTrials.gov lists the study as recruiting.
Peking University People's Hospital
NCT07459673Phase 2RecruitingBreast HERizon-Breast: a ctDNA-guided adaptive study of sequential anti-HER2 therapy
Phase 2 ctDNA-guided study in unresectable locally advanced or metastatic HER2-positive breast cancer. The registry primary outcome is the proportion who maintain a complete response and a molecular complete response. ClinicalTrials.gov lists the study as recruiting.
Memorial Sloan Kettering Cancer Center
NCT07631052Phase 2RecruitingBreast Capecitabine in ER-positive HER2-negative breast cancer with molecular residual disease
Phase 2 trial whose registry primary outcome is the ctDNA clearance rate at 16 weeks of metronomic capecitabine, measured with the Pathlight assay, in people with molecular residual disease. ClinicalTrials.gov lists the study as recruiting.
University Health Network, Toronto