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 Tissue Nanomechanical Phenotype Evaluation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares two radiation schedules before breast cancer surgery: the standard amount and number of doses versus less radiation and fewer doses. It is for adults with certain stages of breast cancer who plan to have a breast removed and rebuilt using their own tissue.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- Tests confirm invasive breast cancer—cancer that has grown into nearby tissue. A test showing cancer in a lymph node also meets this rule.
- Your cancer stage is T3–T4c or N1–N3, which describe tumor growth or spread to nearby lymph nodes. A small group with inflammatory breast cancer must have stage T4d, any N, M1—cancer that has spread to distant parts of the body.
- You plan to have a mastectomy (surgery to remove the breast), but have not had it yet when you join.
- You plan to have the breast rebuilt with a flap of your own tissue.
- If you have HER2-positive cancer that is not inflammatory and had chemotherapy before surgery, cancer must remain in the breast or nearby lymph nodes, or your cancer doctor must record a discussion of how radiation before surgery could affect later drug treatment choices and your choice to join. You may join before the biopsy, but cannot continue under the biopsy rule if it finds no remaining invasive cancer.
- For the inflammatory breast cancer group, an ultrasound after chemotherapy and before radiation must show at least some response in the breast and nearby lymph nodes, with no suspicious nodes above or below the collarbone or near the breastbone.
- You can give written consent to join the study.
Who can't join
- You are being treated for breast cancer that has come back in the affected breast or lymph nodes.
- You have had radiation treatment to the breast, lower neck, central chest, or another area that would overlap with the affected breast.
- You have active scleroderma, a disease that hardens skin and other tissues.
- You are pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
TX
- M D Anderson Cancer Center · Houston, TX 77030Benjamin D. Smith, MD · Study contact · 713-563-2380 · bsmith3@mdanderson.orgBenjamin D. Smith, MD · Principal investigatorMore trials in Houston