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Radiation

Ablative Pre-operative Radiation for Early Stage Breast Cancer

Phase 1
Recruiting
Led By Asal Rahimi, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to the start of study and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Age >/= 18 years old and female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing how much radiation a person can handle before it becomes toxic. They will start with a low amount and work their way up to see how high they can go.

Who is the study for?
This trial is for women over 18 with early-stage breast cancer (tumors up to 3cm, not spread to skin or nodes) who haven't had surgery/chemo for it. They must be estrogen/progesterone receptor positive, Her2neu negative, and able to have an MRI or CEDM. Pregnant/lactating women, those with certain illnesses or a history of breast cancer/radiation are excluded.Check my eligibility
What is being tested?
The study tests escalating doses of single-fraction preoperative partial breast irradiation (S-PBI), starting at 30Gy in one session and potentially increasing to 34Gy and then 38Gy. It aims to find the highest dose that doesn’t cause unacceptable side effects before surgery.See study design
What are the potential side effects?
Potential side effects include skin changes, fatigue, pain or discomfort in the treated area, swelling or fluid build-up. As this is a dose-escalation study assessing toxicity levels, exact side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control during and after the study if I can have children.
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I am a woman and at least 18 years old.
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My scans show no cancer in the lymph nodes under my arm.
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My tumor does not affect the skin on top of it.
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My cancer is located in one spot only.
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I am a woman who can still have children and have not been through menopause.
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My breast cancer is 3 cm or less and hasn't been treated with surgery or drugs yet.
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My cancer is positive for estrogen or progesterone receptors and negative for HER2.
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I have had an MRI or a special mammogram to check the extent of my cancer.
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My largest tumor is 3cm or smaller, measured before biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reach the maximum tolerated dose (MTD)
Secondary outcome measures
Acute Toxicity
Cosmesis outcome
Distant Disease-Free Survival
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single-fraction stereotactic partial breast radiotherapyExperimental Treatment1 Intervention
The primary objective is to escalate the dose of 1 fraction stereotactic partial breast radiotherapy utilizing the MR Linac,Gammapod or Cyberknife system to an ablative dose in the pre-operative setting to the primary tumor without exceeding the maximum tolerated dose in patients with early stage breast cancer.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,043 Previous Clinical Trials
1,053,490 Total Patients Enrolled
21 Trials studying Breast Cancer
6,202 Patients Enrolled for Breast Cancer
Asal Rahimi, MDPrincipal Investigator - UT Southwestern Medical Center
University of Texas Southwestern Medical Center
7 Previous Clinical Trials
5,248 Total Patients Enrolled
3 Trials studying Breast Cancer
113 Patients Enrolled for Breast Cancer

Media Library

Single Fraction Ablative Pre-operative Partial Breast (S-PBI) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04040569 — Phase 1
Breast Cancer Research Study Groups: Single-fraction stereotactic partial breast radiotherapy
Breast Cancer Clinical Trial 2023: Single Fraction Ablative Pre-operative Partial Breast (S-PBI) Highlights & Side Effects. Trial Name: NCT04040569 — Phase 1
Single Fraction Ablative Pre-operative Partial Breast (S-PBI) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04040569 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given clearance for Radiomics on MRI scans?

"Due to the limited amount of clinical data supporting its efficacy and safety, Radiomics on MRI is assigned a score of 1."

Answered by AI

What is the participant base of this clinical research?

"Affirmative. Data hosted on clinicaltrials.gov demonstrates that this research experiment, which was initially posted on December 25th 2019 is currently recruiting for 70 participants at one medical site. Additionally, the post has been refreshed since August 25th 2022."

Answered by AI

Can patients still participate in this experiment?

"Affirmative. Data from clinicaltrials.gov show that this trial is currently recruiting; it was first listed on December 25th of 2019 and the latest edit happened August 25th 2022. The study requires 70 participants to be recruited from 1 site in particular."

Answered by AI
~5 spots leftby Sep 2024