NCT05774678 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
| NCT ID | NCT05774678 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2023-04-05 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 126 participants in total. It began in 2023-04-05 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: * 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: 1. 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. 2. 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. Exclusion Criteria: * 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 & Investigator
Benjamin D. Smith, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05774678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05774678 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 126 participants.
Is NCT05774678 currently recruiting?
Yes, NCT05774678 is actively recruiting participants. Contact the research team at bsmith3@mdanderson.org for enrollment information.
Where is the NCT05774678 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05774678 clinical trial?
NCT05774678 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Benjamin D. Smith, MD at M.D. Anderson Cancer Center. The trial plans to enroll 126 participants.
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