Partial Breast Irradiation for Early Stage Breast Cancer

Recruiting at 14 trial locations

Overseen By Benjamin D Smith

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Bilateral breast cancer, Lupus, Scleroderma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

928 Participants Needed

Trial Summary

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.

Research Team

Benjamin D. Smith, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

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.

Treatment Details

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.

Participant Groups

Group I: Arm I (hypofractionated partial breast irradiation) Experimental Treatment 3 Interventions

Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.

Group II: Arm II (hypofractionated partial breast irradiation) Active Control 2 Interventions

Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.

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

Approved in United States as Partial Breast Irradiation for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in European Union as Partial Breast Irradiation for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

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+