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
2 other identifiers
interventional
126
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
April 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
December 26, 2025
December 1, 2025
3.6 years
February 28, 2023
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
through study completion; an average of 1 year.
Study Arms (2)
Group 1 (preoperative radiation hypofractionated)
EXPERIMENTALParticipants will receive the standard number of radiation treatment doses
Group 2 (preoperative radiation conventionally fractionated)
EXPERIMENTALParticipants will receive the standard number of radiation treatment doses
Interventions
radiation schedules/regimens before your scheduled breast surgery
radiation schedules/regimens before your scheduled breast surgery
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Histologic diagnosis of invasive breast cancer (cytologic or histologic confirmation of nodal metastasis is sufficient to establish this eligibility criteria).
- Clinical and/or pathologic stage T3-T4c OR N1-N3; for the IBC pilot cohort only, the stage requirement is T4d, any N, M1
- Mastectomy is the planned oncologic surgery but has not yet been performed at the time of protocol enrollment
- Autologous (i.e. tissue-based) reconstruction is planned with either a free or rotational flap.
- For patients with HER2 positive, non-IBC breast cancer treated with neoadjuvant chemotherapy, one of the following criteria must be met:
- Residual invasive disease should be documented in either the breast or 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 therapy and will be removed and replaced from the study.
- Medical oncologist has documented a discussion in the chart about potential risks of proceeding with PreMRT with regard to impact on adjuvant systemic therapy decisions and the patient has opted to proceed with trial enrollment
- For T4d pilot cohort patients, post-chemotherapy, pre-radiation ultrasound must demonstrate at least partial response in the breast and regional lymph nodes and no suspicious infraclavicular, internal mammary, and supraclavicular lymph nodes.
- Ability to provide written informed consent in accordance with institutional policies.
You may not qualify if:
- Patients undergoing treatment for recurrent breast cancer in the index breast or lymph nodes.
- History of therapeutic irradiation to the breast, lower neck, mediastinum or other area(s) that will overlap with the affected breast.
- Presence of active scleroderma
- Patients who are pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Artidiscollaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Schaverien MV, Singh P, Kuerer HM, Akay CL, Chavez-MacGregor M, Chu CK, Clemens MW, Qiao W, Smith BD, Hoffman KE. Comparison of Outcomes of Microsurgical Breast Reconstruction after Premastectomy and Postmastectomy Radiation Therapy. J Am Coll Surg. 2025 Oct 1;241(4):535-549. doi: 10.1097/XCS.0000000000001444. Epub 2025 Sep 16.
PMID: 40366003DERIVEDSchaverien MV, Singh P, Smith BD, Qiao W, Akay CL, Bloom ES, Chavez-MacGregor M, Chu CK, Clemens MW, Colen JS, Ehlers RA, Hwang RF, Joyner MM, Largo RD, Mericli AF, Mitchell MP, Shuck JW, Tamirisa N, Tripathy D, Villa MT, Woodward WA, Zacharia R, Kuerer HM, Hoffman KE. Premastectomy Radiotherapy and Immediate Breast Reconstruction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245217. doi: 10.1001/jamanetworkopen.2024.5217.
PMID: 38578640DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin D. Smith, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2023
First Posted
March 20, 2023
Study Start
April 5, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2028
Last Updated
December 26, 2025
Record last verified: 2025-12