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Radiation Therapy

Partial Breast Irradiation for Breast Cancer

Phase 2

Waitlist Available

Led By Simon Powell, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unicentric Stage I (T1N0M0) invasive ductal breast cancer or Grade 1 or II DCIS measuring <2 cm on pathology and/or mammogram that is histologically confirmed at MSKCC

Patients with T1N0(i+) tumors on sentinel lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible

Must not have

Patients with distant metastasis

Histologic evidence of EIC, defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two types of radiation therapy given after breast surgery to see if one is better than the other.

Who is the study for?

This trial is for women over 18 with early-stage invasive ductal breast cancer or Grade 1/2 DCIS, measuring less than 2 cm. They must have a performance status indicating they can carry out daily activities without significant restrictions and adequate blood cell counts. Exclusions include prior breast surgeries, psychiatric conditions affecting consent, other ongoing cancer treatments, pregnancy/breastfeeding, certain genetic mutations like BRCA, and uncontrolled medical conditions.

What is being tested?

The study tests Partial Breast Irradiation (PBI) as an alternative to Whole Breast Irradiation (WBI) in treating early-stage breast cancer post-lumpectomy. PBI targets only the tumor area for two weeks instead of the entire breast for five to seven weeks. The goal is to assess side effects and how effectively PBI prevents cancer recurrence.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of radiation therapy like PBI may include skin changes similar to sunburns in the treated area, fatigue due to body's repair response to radiation damage, mild swelling or tenderness of the breast tissue.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is early stage, small, and confirmed by tests at MSKCC.

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My cancer is in an early stage and was found in a sentinel lymph node but is very small.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My blood test shows enough granulocytes and platelets for chemotherapy.

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My cancer surgery showed clear margins of 2mm or more, or no cancer in the final tissue removed.

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I am female.

Exclusion Criteria

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

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My cancer has spread to distant parts of my body.

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My breast cancer has a specific pattern of growth involving the ducts.

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I have had cosmetic or reconstructive surgery on my breast.

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I am enrolled or plan to enroll in another treatment study for my breast cancer.

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Partial breast irradiation is not an option for me.

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I have had radiation therapy on the same or opposite side of my chest before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate the safety of PBI-directed external-beam radiation therapy

Secondary study objectives

To evaluate local control rates

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation treatmentExperimental Treatment1 Intervention

This is a Phase II single-arm study of PBI with external-beam radiation therapy in which a group of select women with early-stage invasive and noninvasive breast cancer will be given radiation to the partial breast.

0 / 13Eligibility criteria met