CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 120 target
Drug / intervention
Undergo EBRT +4 moreradiation
Likely dose
Not stated in record
Key inclusion· 18
  • ✓Pathologically confirmed unicentric invasive breast cancer, clinical stage T1-T2 (≤5 cm), N0-N1 (≤4 abnormal nodes), M0
  • ✓HER2 positive (IHC 3+ or FISH amplified) or triple receptor negative (ER/PR<10%, HER2 negative) receiving NST for Cohorts A1/A2
  • ✓ER and/or PR positive, HER2 negative, clinical stage T1N0M0, unicentric non-lobular, no lymphovascular invasion for Cohort B
  • ✓Patient desires breast conserving therapy
Key exclusion· 7
  • ✕Stage T3 or T4 disease for Cohorts A/C; T2-T3 or T4 for Cohort B
  • ✕Clinical or pathologic evidence of distant metastases
  • ✕Prior invasive or DCIS breast cancer in ipsilateral breast
  • ✕Clinical progression >20% in breast or new nodal metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02945579
NCT02945579N/ARecruitingOn TrackUpdated 3mo ago
Long Recruiting
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Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy

M.D. Anderson Cancer Center·interventional·Posted Oct 26, 2016·Updated Mar 9, 2026

In Brief

A clinical study evaluating Undergo EBRT, Laboratory Biomarker Analysis, and 3 other interventions for Estrogen Receptor Negative and 11 related conditions. Currently recruiting, targeting 120 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEstrogen 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ARecruiting
201720182019202020212022202320242025202620272028
First PostedOct 26, 2016
Enrollment StartJan 20, 2017
Primary CompletionJan 31, 2028
TodayJul 2, 2026
Enrollment to primary: 11.0 yearsPosted 9.7 years agoPrimary completion in 1.6 years

Interventions

Undergo EBRTradiation

Undergo EBRT

Laboratory Biomarker Analysisother

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Partial Breast Irradiationradiation

Undergo partial breast irradiation