Comparing two types of preoperative radiation for breast cancer patients
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
This study is testing whether a shorter or longer schedule of radiation before surgery helps breast cancer patients feel better and have fewer complications after their treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05774678 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the effectiveness and outcomes of hypofractionated versus conventionally fractionated preoperative radiation therapy in patients undergoing mastectomy and immediate autologous breast reconstruction. The study will evaluate patient satisfaction, oncologic outcomes, surgical complications, and quality of life following the two different radiation schedules. Additionally, it will assess the financial impact and health services outcomes related to the treatment. Nanomechanical properties of breast cancer tissue will also be evaluated to understand their association with treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with invasive breast cancer who are planning to undergo mastectomy and autologous reconstruction.
Not a fit: Patients with non-invasive breast cancer or those not planning for mastectomy and reconstruction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient satisfaction and better oncologic outcomes for breast cancer patients undergoing surgery.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiation approaches, suggesting potential benefits in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Benjamin D. Smith, MD — M.D. Anderson Cancer Center
- Study coordinator: Benjamin D. Smith, MD
- Email: bsmith3@mdanderson.org
- Phone: (713) 563-2380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.