928 Participants Needed

Partial Breast Irradiation for Early Stage Breast Cancer

Recruiting at 14 trial locations
BD
Overseen ByBenjamin D Smith
Age: 18+
Sex: Female
Trial Phase: Phase 2 & 3
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.

Who Is on the Research Team?

BD

Benjamin D. Smith, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with early stage breast cancer who've had breast conserving surgery, have estrogen receptor positive tumors, and no evidence of disease from prior non-breast cancers. It's not for those with nodal positivity beyond pN0(i+), history of radiation in the area, or previous invasive/in situ breast cancer.

Inclusion Criteria

My breast cancer has not spread to my lymph nodes.
My cancer is mainly in one spot, but small areas nearby may also have cancer.
My final surgery showed no cancer cells at the edges of the removed tissue.
See 7 more

Exclusion Criteria

I have had breast cancer before.
I have had radiation therapy in the chest area before.
I have a history of lupus or scleroderma.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo hypofractionated partial breast irradiation daily for 5 days or standard breast irradiation daily for 15 days, with optional boost fractions

1-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5.5 years
Visits at 6 months, 1.5, 3.5, and 5.5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Partial Breast Irradiation
Trial Overview The study tests hypofractionated partial breast irradiation to see if delivering higher doses over a shorter period is effective and results in fewer side effects than standard treatment. Only the part of the breast where cancer started is treated.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (hypofractionated partial breast irradiation)Experimental Treatment3 Interventions
Group II: Arm II (hypofractionated partial breast irradiation)Active Control2 Interventions

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

🇺🇸
Approved in United States as Partial Breast Irradiation for:
🇪🇺
Approved in European Union as Partial Breast Irradiation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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