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Radiation
Preoperative Radiation Schedules for Breast Cancer
Phase 3
Recruiting
Led By Benjamin D. Smith, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- 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
Autologous (i.e. tissue-based) reconstruction is planned with either a free or rotational flap
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial compares two different radiation therapy schedules to treat breast cancer before surgery.
Who is the study for?
This trial is for adults over 18 with invasive breast cancer who plan to have tissue-based reconstruction after mastectomy. It's open to those with certain advanced stages of cancer, including T3-T4c or N1-N3 and even stage T4d in specific cases. Patients must not have had previous radiation in the affected area, be pregnant, or have recurrent breast cancer or active scleroderma.Check my eligibility
What is being tested?
The TOPAz trial compares two preoperative radiation schedules before breast surgery: a hypofractionated course (less radiation in fewer doses) versus a conventionally fractionated one (standard amount and number of doses). The goal is to see which method works better for patients undergoing mastectomy followed by immediate autologous reconstruction.See study design
What are the potential side effects?
Potential side effects from both types of radiation may include skin irritation, fatigue, swelling at the treatment site, changes in skin coloration and texture, pain or discomfort around the radiated area. Long-term effects can vary depending on individual patient factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
After chemotherapy, my ultrasound showed improvement in my breast and nearby lymph nodes without any suspicious nodes in the chest area.
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I plan to have breast reconstruction using my own tissue.
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My breast cancer is at an advanced stage but has not spread far.
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I am 18 years old or older.
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My breast cancer diagnosis was confirmed through tissue examination.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2 (preoperative radiation conventionally fractionated)Experimental Treatment2 Interventions
Participants will receive the standard number of radiation treatment doses
Group II: Group 1 (preoperative radiation hypofractionated)Experimental Treatment2 Interventions
Participants will receive the standard number of radiation treatment doses
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Who is running the clinical trial?
ArtidisUNKNOWN
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,239 Total Patients Enrolled
147 Trials studying Breast Cancer
63,160 Patients Enrolled for Breast Cancer
Benjamin D. Smith, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- After chemotherapy, my ultrasound showed improvement in my breast and nearby lymph nodes without any suspicious nodes in the chest area.I plan to have breast reconstruction using my own tissue.My breast cancer is HER2 positive and I've had chemotherapy before surgery.I am 18 years old or older.My breast cancer is at an advanced stage but has not spread far.I have active scleroderma.I have had radiation therapy on my breast, lower neck, or chest area.I am scheduled for a mastectomy but haven't had the surgery yet.I am currently being treated for breast cancer that has come back in the same breast or lymph nodes.I discussed the risks of PreMRT with my doctor and chose to join the trial.My breast cancer diagnosis was confirmed through tissue examination.I still have cancer in my breast or lymph nodes after chemotherapy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (preoperative radiation hypofractionated)
- Group 2: Group 2 (preoperative radiation conventionally fractionated)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the preoperative radiation hypofractionated protocol endorsed by the FDA?
"Our evaluation of Group 1's safety by Power is a 3, as the Phase 3 trial has seen multiple data collections verifying its efficacy and security."
Answered by AI
Are participants currently being recruited for this experiment?
"According to clinicaltrials.gov, this research is no longer accepting patients. The study was initially posted on August 31st 2023 and has not been updated since March 15th 2023. Despite the closure of this trial, there are 1423 other studies currently recruiting participants."
Answered by AI
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