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Study on Eliminating Surgery or Radiation for Breast Cancer

This study is looking at whether some breast cancer patients can avoid surgery or radiation therapy. It focuses on women aged 30 and older with specific types of breast cancer: HER2-positive, triple-negative, or ER-positive/HER2-negative. The study is testing different approaches. For some, after initial treatment (systemic therapy or endocrine therapy and ablative radiotherapy), if image-guided biopsies show no cancer remaining, they might receive standard radiation or endocrine therapy without surgery. For others with HER2-positive or triple-negative breast cancer who have surgery, the study explores eliminating radiation if surgery pathology shows no remaining cancer. Researchers will track how many patients have cancer return in the breast (ipsilateral breast tumor recurrence-free survival) and overall survival for up to 10 years.

Study design
This is an interventional study with a planned enrollment of 120 women. It is not specified if it's randomized or blinded.
What's involved
Participants may undergo radiation (EBRT or partial breast irradiation), laboratory biomarker analysis, quality-of-life assessments, and questionnaire administration. The duration of participation is up to 10 years for follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years to assess ipsilateral breast tumor recurrence-free survival and overall survival.

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NCT02945579

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

Recruiting
NAAges 30+InterventionalTreatment
M.D. Anderson Cancer Center
~120 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:Undergo EBRTLaboratory Biomarker AnalysisQuality-of-Life AssessmentQuestionnaire AdministrationPartial Breast Irradiation

At a glance

Recruiting sites
6 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ipsilateral breast tumor recurrence-free survival (IBT-RFS)
Measured over From confirmation of pathologic complete response (pCR) to the time of ipsilateral breast tumor recurrence or death, whichever occurs first or the time of last contact, assessed for up to 10 years
+1 more outcome measured

Conditions

Estrogen Receptor Negative
HER2 Positive Breast Carcinoma
HER2/Neu Negative
Invasive Breast Carcinoma
Progesterone Receptor Negative
Stage I Breast Cancer AJCC v7
Stage IA Breast Cancer AJCC v7
Stage IB Breast Cancer AJCC v7
Stage II Breast Cancer AJCC v6 and v7
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Triple-Negative Breast Carcinoma

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Where it's being run

8 sites across 8 states
Arizona1
Florida1
Hawaii1
Minnesota1
New Jersey1
North Carolina1
Pennsylvania1
Texas1

Study leadership

  • Henry M Kuerer · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Henry Kuerer
[email protected]
713-745-5043
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Eligibility criteria

Inclusion

Cohort A1 and A2
Cohort B1 and B2
Cohort C
Cohort D (MD Anderson Houston patients only)
Conditions for patient eligibility: Patients on this portion of the study meet all eligibility requirements for cohort C, but have not enrolled onto the study to omit radiation. Patients in Cohort D can be identified at the time of diagnosis or prior to lumpectomy. They are not required to participate in one of the treatment arms of the study, but can ultimately choose to move to an omission Cohort at a later time point.

What this trial measures

  • Ipsilateral breast tumor recurrence-free survival (IBT-RFS)From confirmation of pathologic complete response (pCR) to the time of ipsilateral breast tumor recurrence or death, whichever occurs first or the time of last contact, assessed for up to 10 years

    Will monitor IBT-RFS using the method of Thall et al. Will be estimated using the Kaplan-Meier method log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.

  • Overall survivalUp to 10 years

    Will be estimated using the Kaplan-Meier method log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.