Study on Radiation Therapy Before Surgery for Patients with Hormone Receptor Positive, HER2 Negative Breast Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT03359954
This clinical trial is exploring the effectiveness of using radiation therapy before surgery to treat patients with hormone receptor positive, HER2 negative breast cancer. The aim is to see if this approach can shrink the tumor and reduce the amount of normal tissue that needs to be removed during surgery.
Patient Parameters
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Program Overview
The purpose of this study is to determine how well radiation therapy works when given before surgery in patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors. By administering radiation before surgery, the goal is to make the tumor smaller, which may help preserve more normal breast tissue during the operation.
Description
The main goal of this study is to evaluate changes in the number of immune cells within the tumor before and after receiving radiation therapy prior to surgery. Researchers will also assess the safety of this approach and explore how the radiation affects cancer cells and the immune system. Additionally, the study will investigate whether MRI scans can predict how well the tumor responds to the radiation treatment.
Participants will receive a boost of radiation therapy 6-8 days before their scheduled breast surgery. After surgery, they will continue with standard radiation therapy as part of their usual care. The study will follow up with participants six months after completing the treatment to monitor their progress.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of hormone receptor positive, HER2 negative invasive breast cancer.
- Have a marker placed in the primary breast cancer.
- Have a tumor that can be measured by ultrasound and is at least 1 cm in size.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have signed a written informed consent.
- Be evaluated by a team of specialists, including a Breast Surgical Oncologist and a Breast Radiation Oncologist. If considering breast reconstruction or specific surgical techniques, a plastic surgeon will also be involved.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Have a condition that prevents them from receiving radiation therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| M D Anderson Cancer Center | 77030 | Houston | Texas |
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