Study Summary
This trial is testing whether eliminating surgery and just using radiation therapy after systemic therapy works well in treating patients with HER2 positive or triple negative breast cancer.
Eligible Conditions
- Estrogen Receptor Negative Breast Cancer
- HER2-positive Breast Cancer
- HER2/Neu Negative Breast Cancer
- Breast Cancer
- Progesterone Receptor Negative Breast Cancer
- Stage I Breast Cancer
- Stage IA Breast Cancer
- Stage IB Breast Cancer
- Stage II Breast Cancer
- Stage IIA Breast Cancer
- Stage IIB Breast Cancer
- Triple Negative Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: Up to 5 years
Month 12
Change in biomarkers in blood and plasma
Month 60
Quality of Life measured by BCTOS questionnaire
Quality of Life measured by DRS questionnaire
Quality of Life measured by FACT-B+4 questionnaire
Year 5
Ipsilateral breast tumor recurrence-free survival (IBT-RFS)
Up to 5 years
Incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up
Overall survival
Residual cancer burden (RCB)
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Treatment (whole breast irradiation, EBRT)
1 of 4
Cohort A
1 of 4
Cohort B
1 of 4
Cohort C
1 of 4
Experimental Treatment
120 Total Participants · 4 Treatment Groups
Primary Treatment: Quality-of-Life Assessment · No Placebo Group · N/A
Treatment (whole breast irradiation, EBRT)Experimental Group · 5 Interventions: External Beam Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Whole Breast Irradiation · Intervention Types: Radiation, Other, Other, Other, Radiation
Cohort AExperimental Group · 5 Interventions: External Beam Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Whole Breast Irradiation · Intervention Types: Radiation, Other, Other, Other, Radiation
Cohort BExperimental Group · 5 Interventions: External Beam Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Whole Breast Irradiation · Intervention Types: Radiation, Other, Other, Other, Radiation
Cohort CExperimental Group · 5 Interventions: External Beam Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Whole Breast Irradiation · Intervention Types: Radiation, Other, Other, Other, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3050
Whole Breast Irradiation
2017
N/A
~160
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,828 Previous Clinical Trials
1,792,556 Total Patients Enrolled
146 Trials studying Breast Cancer
31,736 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,167 Previous Clinical Trials
41,168,339 Total Patients Enrolled
928 Trials studying Breast Cancer
1,536,821 Patients Enrolled for Breast Cancer
Henry M KuererPrincipal InvestigatorM.D. Anderson Cancer Center
Eligibility Criteria
Age 18+ · Female Participants · 26 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You want to have surgery to remove breast cancer while keeping most of your breast intact.
References
- Kuerer HM, Smith BD, Krishnamurthy S, Yang WT, Valero V, Shen Y, Lin H, Lucci A, Boughey JC, White RL, Diego EJ, Rauch GM; Exceptional Responders Clinical Trials Group. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 Oct 25. pii: S1470-2045(22)00613-1. doi: 10.1016/S1470-2045(22)00613-1. [Epub ahead of print]
- Hariharan N, Rao TS, Rajappa S, Naidu CCK. Precision medicine - A new era in multidisciplinary care. Cancer Treat Res Commun. 2022;32:100577. doi: 10.1016/j.ctarc.2022.100577. Epub 2022 May 17.
- Kuerer HM, Smith BD, Krishnamurthy S, Yang WT, Valero V, Shen Y, Lin H, Lucci A, Boughey JC, White RL, Diego EJ, Rauch GM; Exceptional Responders Clinical Trials Group. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 Oct 25:S1470-2045(22)00613-1. doi: 10.1016/S1470-2045(22)00613-1. Online ahead of print.
- Hariharan N, Rao TS, Rajappa S, Naidu CCK. Precision medicine - A new era in multidisciplinary care. Cancer Treat Res Commun. 2022;32:100577. doi: 10.1016/j.ctarc.2022.100577. Epub 2022 May 17. No abstract available.
- Kuerer HM, Smith BD, Krishnamurthy S, Yang WT, Valero V, Shen Y, Lin H, Lucci A, Boughey JC, White RL, Diego EJ, Rauch GM; Exceptional Responders Clinical Trials Group. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 Dec;23(12):1517-1524. doi: 10.1016/S1470-2045(22)00613-1. Epub 2022 Oct 25.
- 2017. "Eliminating Surgery or Radiotherapy After Systemic Therapy in Treating Patients With HER2 Positive or Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02945579.
Frequently Asked Questions
Are researchers enrolling people in this clinical trial at this time?
"This trial is still recruiting patients, with the latest update having been on September 27th, 2022. The original posting date was January 20th, 2017." - Anonymous Online Contributor
Unverified Answer
Are other research hospitals in Canada also administering this trial?
"Patients are being recruited for this study at Mayo Clinic in Rochester, Minnesota; M D Anderson Cancer Center in Houston, Texas; Baptist MD Anderson Cancer Center in Jacksonville, Florida; and six additional sites." - Anonymous Online Contributor
Unverified Answer
How many total enrollees are in this clinical research program?
"To run this study successfully, we need 120 patients that fit the given inclusion criteria. Some of the places where patients can participate in this trial include Mayo Clinic in Rochester, Minnesota and M D Anderson Cancer Center in Houston, Texas." - Anonymous Online Contributor
Unverified Answer