Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2025-12-26
126
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Artidis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologic diagnosis of invasive breast cancer (cytologic or histologic confirmation of nodal metastasis is sufficient)
- Clinical and/or pathologic stage T3-T4c OR N1-N3; for the inflammatory breast cancer pilot cohort, stage T4d, any N, M1
- Planned mastectomy with autologous (tissue-based) reconstruction using a free or rotational flap
- For HER2 positive, non-inflammatory breast cancer patients treated with neoadjuvant chemotherapy, residual invasive disease must be documented post-chemotherapy or documented discussion of risks with opting into the trial
- For T4d pilot cohort patients, post-chemotherapy ultrasound must show at least partial response in breast and regional lymph nodes with no suspicious infraclavicular, internal mammary, or supraclavicular lymph nodes
- Ability to provide written informed consent according to institutional policies
You will not qualify if you...
- Treatment for recurrent breast cancer in the same breast or lymph nodes
- Prior therapeutic radiation to the breast, lower neck, mediastinum, or overlapping areas
- Active scleroderma
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Benjamin D. Smith, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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