22 Participants Needed

Pre-Surgery Radiation for Early-Stage Breast Cancer

OS
SM
Overseen BySohyun McElroy, Ph.D.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
Must be taking: Anti-endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Research Team

SB

Sasha Beyer, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for women over 50 with stage I breast cancer that's hormone responsive and hasn't spread. They must be able to have an MRI, lie prone during treatment, and agree to surgery after radiation. Excluded are those with large tumors (>3cm), prior breast treatments, or certain other cancers within the last 5 years.

Inclusion Criteria

You are able to undergo an MRI with a special dye called contrast.
A core biopsy shows breast cancer with positive estrogen or progesterone receptors.
Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI.
See 11 more

Exclusion Criteria

Breast cancer that does not respond to hormone treatment.
You are planning to have a mastectomy.
You don't want to receive hormone therapy.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo image-guided intensity-modulated accelerated partial breast irradiation (APBI) twice daily in the prone position

5-10 days
10 visits (in-person)

Surgery

Participants undergo lumpectomy within 4-6 weeks post-APBI

4-6 weeks post-radiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
1 visit at 4 weeks, then every 6 months

Treatment Details

Interventions

  • Accelerated Partial Breast Irradiation
  • Image-Guided Radiation Therapy
  • Intensity-Modulated Radiation Therapy
  • Therapeutic Conventional Surgery
Trial Overview The study tests if giving a high-dose radiation therapy called intensity-modulated accelerated partial breast irradiation (APBI) before surgery can shrink tumors more effectively while sparing healthy tissue in older patients with early-stage hormone-positive breast cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (image-guided intensity-modulated APBI)Experimental Treatment4 Interventions
Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.

Accelerated Partial Breast Irradiation is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as APBI for:
  • Early-stage breast cancer
  • Ductal carcinoma in situ (DCIS)
  • Stage I or II breast cancer
🇪🇺
Approved in European Union as APBI for:
  • Early-stage breast cancer
  • Ductal carcinoma in situ (DCIS)
  • Stage I or II breast cancer
🇨🇦
Approved in Canada as APBI for:
  • Early-stage breast cancer
  • Ductal carcinoma in situ (DCIS)
  • Stage I or II breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+
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