RecruitingNot ApplicableNCT05464667

Preoperative Irradiation for Stage I Breast Cancer

Preoperative Irradiation for Stage I Breast Cancer: A Phase IB Study


Sponsor

Parul Barry

Enrollment

21 participants

Start Date

Jul 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving radiation therapy before surgery — instead of after — is safe and effective for women with early-stage breast cancer. This approach, called preoperative (or neoadjuvant) radiotherapy, may allow a smaller area of the breast to be treated while still preventing cancer from coming back. **You may be eligible if...** - You are female and 50 or older - You have confirmed breast cancer with a tumor 3 cm or smaller (invasive) or 4 cm or smaller (DCIS) - Your cancer has not spread to distant organs - You are planning to have breast-conserving surgery (lumpectomy) **You may NOT be eligible if...** - You have already received chemotherapy or hormone therapy for this cancer - You have had prior radiation to the chest - Your cancer has spread to the lymph nodes or beyond Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation Therapy (RT)

Dose Escalation: 4 Cohorts - 30 GY in 5 fractions (baseline treatment with 0 boost dose to GTV), 35, 40, 50 Gy in 5 fractions (Par 1) Dose Expansion: Maximum Tolerated Dose determined during dose escalation (Part 2)


Locations(1)

UPMC Magee Womens Hospital - Radiation Oncology

Pittsburgh, Pennsylvania, United States

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NCT05464667


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