RecruitingNot ApplicableNCT02945579

Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy


Sponsor

M.D. Anderson Cancer Center

Enrollment

120 participants

Start Date

Jan 20, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial studies eliminating surgery and/or radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual cancer, patients then receive standard breast radiotherapy with no surgery. In ER positive/HER2 negative breast cancers, after endocrine therapy and ablative radiotherapy, when image-guided biopsy shows no residual cancer, patients then receive standard endocrine therapy with no surgery. For patients who have HER2 positive and triple negative breast cancers and standard surgery, after systemic therapy, breast radiotherapy is being eliminated when the pathology from surgery shows no residual cancer.


Eligibility

Sex: FEMALEMin Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study asks whether women with breast cancer who respond completely to pre-surgery drug treatment (neoadjuvant therapy) — meaning no cancer can be found on biopsy — can safely skip surgery (lumpectomy) and/or radiation, avoiding the side effects of these procedures. **You may be eligible if...** - You have been diagnosed with invasive breast cancer (stage T1 or T2, meaning tumor 5 cm or smaller) - Your cancer has not spread to distant organs - You are being treated with standard neoadjuvant (pre-surgery) drug therapy - You are being treated at MD Anderson Cancer Center or a participating site **You may NOT be eligible if...** - You have inflammatory breast cancer (a rare, aggressive form) - Your cancer has spread to distant organs - You have already had radiation to the chest area - You are pregnant For women who achieve a complete response to drug treatment, avoiding surgery and radiation could maintain quality of life without compromising survival. 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

RADIATIONUndergo EBRT

Undergo EBRT

OTHERLaboratory Biomarker Analysis

Correlative studies

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONPartial Breast Irradiation

Undergo partial breast irradiation


Locations(8)

MD Anderson Cancer Center - Banner

Gilbert, Arizona, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Mayo Clinic

Rochester, Minnesota, United States

Cooper Hospital Univ Med Ctr, MD Anderson at Cooper Voorhees

Voorhees Township, New Jersey, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT02945579


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