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Radiation Therapy

Pre-Surgery Radiation Therapy for Breast Cancer

Phase 2

Waitlist Available

Led By Simona F Shaitelman

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast

Must not have

Women who are pregnant or breast-feeding

Contraindication to receive radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 to 8 days after preoperative radiotherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer.

Who is the study for?

This trial is for adults with hormone receptor positive, HER2 negative breast cancer who are fit enough for treatment (ECOG 0-1). They must have a tumor that can be biopsied and measured on ultrasound, agree to see multiple specialists, and not be pregnant or breastfeeding. A clip should already be in place in the primary breast cancer.

What is being tested?

The study is testing if giving radiation therapy before surgery can shrink tumors effectively in patients with specific types of breast cancer. The goal is to potentially reduce the amount of healthy tissue removed during surgery.

What are the potential side effects?

Radiation therapy may cause skin irritation, fatigue, swelling or firmness where treated, changes in skin color, and rarely more serious effects like heart problems or secondary cancers.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My breast cancer is HR+ and HER2- as confirmed by tests.

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My breast tumor is at least 1cm big, as shown by ultrasound.

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I am 18 years old or older.

Exclusion Criteria

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

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I am not pregnant or breast-feeding.

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I cannot undergo radiotherapy due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 to 8 days after preoperative radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 to 8 days after preoperative radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 to 8 days after preoperative radiotherapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL)

Secondary study objectives

Changes in dynamic contrast enhanced (DCE)

Delay Rate of Surgery Following Boost RT

Toxicity calculated using the CTCAE v4.0

+1 more

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: Treatment (radiation therapy, surgery)Experimental Treatment2 Interventions

Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9630