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Trial Of PreoperAtive Radiation (TOPAz): A Randomized Trial Comparing Hypofractionated Versus Conventionally Fractionated Preoperative Radiation Followed by Mastectomy With Immediate Autologous Breast Reconstruction With Integrated Nanomechanical Biomarker Evaluation

StatusRecruiting
PhasePhase 3
Started2023-04-05
View on ClinicalTrials.gov ↗

Amendment history

2026-06-19
2 amendments v9-v10
2 re-verifications since 2025-12-19, no change to tracked fields
2025-06-06
Study Identification, Study Status, Oversight, Study Description, Contacts/Locations, IPDSharing v8
Study description-702 characters
Primary Objectives: --To compare BREAST-Q satisfaction with breasts 18 months afte [...] will be superior to CF-PreMRT with regard to this endpoint. Secondary Objectives: To compare oncologic outcomes following HF-PreMRT versus CF- [...] F-PreMRT, including acute and late toxicities and fibrosis. Secondary Objectives: To compare health services research outcomes following HF-Pr [...] city, work productivity and disability, total cost of care, complication-relatedcomplicationrelated cost of care, and health utility. To compare patient-report [...] d quality of life and toxicities following HF-PreMRT versus CF-PreMRTCFPreM [...] [...]
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Trial ofOf PreoperAtive Radiation (TOPAz): aA Randomized Trial Comparing Hypofractionated Versus Conventi [...] Fractionated Preoperative Radiation Followed by Mastectomy withWith Immediate Autologous Breast Reconstruction withWith Integrated Nanomechanical Biomarker Evaluation
2024-12-12
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v7
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Trial Ofof PreoperAtive Radiation (TOPAz): Aa Randomized Trial Comparing Hypofractionated Versus Conventi [...] Fractionated Preoperative Radiation Followed by Mastectomy Withwith Immediate Autologous Breast Reconstruction Withwith Integrated Nanomechanical Biomarker Evaluation
2024-06-05
Study Status v6
Re-verified, no change to tracked fields
2024-03-20
Study Status, Eligibility v5
Eligibility criteria+18 characters
[...] sufficient to establish this eligibility criteria). Clinical and/or pathologic stage T3-T4c OR N1-N3; for the IBC pilot cohort only, the s [...]
Show 4 earlier versions
2024-02-15
Study Status v4
Re-verified, no change to tracked fields
2023-09-26
Study Status, Eligibility v3
Eligibility criteria+353 characters
[...] a regional nodal metastasis after neoadjuvant chemotherapy. This specific eligibility criteria can be satisfied by the post-chemotherapy standard of care breast biopsy. For this matter, the patient may be enrolled on the trial prior to biopsy. If the biopsy does not show residual invasive disease, then the patient will not proceed with protocol-directed ther [...] Medical oncologist has documented a discussion in the chart [...]
2023-08-09
Study Status v2
Re-verified, no change to tracked fields
2023-04-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-08-31→confirmed 2023-04-05
Study sitesdetails revised at 1 of 1 site
2023-03-15
Original filing
To compare the outcomes of and responses to 2 different radiation therapy schedules (the standard radiation amount and number of doses versus less radiation and fewer doses) that are being given before having breast cancer surgery (cancer removal and reconstruction).
Trial Details
NCT Number NCT05774678
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Artidis
Conditions Breast Cancer
Enrollment 126 participants
Start Date 2023-04-05
Primary Completion 2026-11-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-23