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Radiation

Partial Breast Irradiation for Early Stage Breast Cancer

Phase 2 & 3

Waitlist Available

Led By Benjamin D Smith

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 patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS

Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded

Must not have

History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast

History of lupus or scleroderma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well a shorter, higher-dose radiation therapy works to treat early stage breast cancer. The cancer is only in the breast, and this treatment may have fewer side effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin changes, fatigue, pain or discomfort at the treatment site. Since it's localized therapy, systemic side effects are less common compared to full-breast radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer has not spread to my lymph nodes.

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My final surgery showed no cancer cells at the edges of the removed tissue.

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My invasive cancer is estrogen receptor positive.

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I had cancer other than breast cancer, finished treatment over a month ago, and currently show no signs of it.

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My breast cancer is in a specific area that can be targeted with radiation.

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My breast tumor is 3 cm or smaller.

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I have been diagnosed with invasive breast cancer or ductal carcinoma in situ.

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I had surgery to remove part of my breast.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy in the chest area before.

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I have a history of lupus or scleroderma.

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My cancer has spread to my skin, chest wall, or muscle.

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I received chemotherapy before my final breast-saving surgery.

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I have had breast cancer before.

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I have been diagnosed with cancer in both breasts.

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My cancer has spread to my lymph nodes beyond the earliest stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Risk of grade 2 or higher toxicity

Secondary study objectives

Disease free survival (DFS)

Feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network

Incidence of adverse events

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (hypofractionated partial breast irradiation)Experimental Treatment3 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 Control2 Interventions

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

0 / 15Eligibility criteria met