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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

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

Find a Location

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

Group 1 (preoperative radiation hypofractionated) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05774678 — Phase 3
Group 1 (preoperative radiation hypofractionated) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05774678 — Phase 3
Breast Cancer Research Study Groups: Group 1 (preoperative radiation hypofractionated), Group 2 (preoperative radiation conventionally fractionated)
Breast Cancer Clinical Trial 2023: Group 1 (preoperative radiation hypofractionated) Highlights & Side Effects. Trial Name: NCT05774678 — Phase 3

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
~84 spots leftby Nov 2026