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Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer

StatusRecruiting
PhasePhase 2
Started2023-01-25
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 15 months later May 2028 → Sep 2029
See other at-risk trials from H. Lee Moffitt Cancer Center and Research Institute

Amendment history

2026-09-26
Primary completion pushed: 2028-05 → 2029-09
Completion pushed: 2028-05 → 2029-09
2026-02-05
2 amendments v17-v18
2 re-verifications since 2025-11-12, no change to tracked fields
2025-09-09
Study Status, Contacts/Locations v16
Study sitescontacts updated at 1 of 2 sites
2025-08-20
Study Status v15
Primary completion date2026-01→2028-05
Completion date2027-01→2028-05
2025-04-16
Study Status v14
Re-verified, no change to tracked fields
Show 13 earlier versions
2025-01-22
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 2 sites
2024-09-06
Study Status, Contacts/Locations v12
Study sitescontacts updated at 2 of 2 sites
2024-07-02
Study Status, Eligibility v11
Eligibility criteria+1 characters
[...] mone receptor (HR)- disease, a breast cancer must express (<510%), by immunohistochemistry (IHC), the hormone receptors (es [...]
2024-06-25
Study Status v10
Primary completion date2025-11-01→2026-01
Completion date2026-11-01→2027-01
Start date2022-11-04→2023-01-25
2024-01-24
2 amendments v8-v9
2 re-verifications since 2023-07-28, no change to tracked fields
2023-05-11
Study Status, Eligibility v7
Eligibility criteria+588 characters
[...] tion of Triple Negative (TN) breast cancer by tissue biopsy Adequate tissue to calculate RSI To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines To fulfill the requirement of horm [...] Life expectancy >16 weeks KPS ≥ 70 Age ≥ 18 years Participan [...]
2023-02-22
Study Status v6
Re-verified, no change to tracked fields
2023-02-17
Study Status, Contacts/Locations v5
Study sites1→2
2022-11-14
Study Status v4
Start dateestimated 2022-11-01→confirmed 2022-11-04
2022-11-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2022-12-30→2022-11-01
Study sitesdetails revised at 1 of 1 site
2022-11-01
Study Status v2
Start date2022-09-30→2022-12-30
2022-09-06
Study Identification, Study Status, Arms and Interventions, Outcome Measures v1
InterventionsGenomically Guided Radiation Therapy (Radiation)→Genomically Guided Radiation Therapy (Radiation), Genomically Guided Radiation Therapy (Radiation)
Study title+15 characters
Genomically Guided RTRadiation Therapy in the Management of Triple Negative Breast Cancer
2022-09-01
Original filing
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.
Trial Details
NCT Number NCT05528133
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Conditions Triple Negative Breast Cancer
Enrollment 86 participants
Start Date 2023-01-25
Primary Completion 2029-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-25