Study Summary
This trial is comparing two types of radiation therapy to treat early-stage breast cancer.
Eligible Conditions
- Stage IB Breast Cancer
- Breast Cancer, Stage II
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Time from randomization to death from any cause, assessed up to 10 years
Month 24
Effect of radiation therapy on cosmetic outcome in mastectomy and lumpectomy patients as assessed by quality of life questionnaire
Year 10
OS
Year 10
DFS-DCIS
Year 10
LRRFI
Year 10
Time to SPC
Year 10
DRFI
Year 10
IBC-RFI
Day 90
Molecular predictors of recurrence
Day 30
Frequencies of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Group 1A Lumpectomy: no regional nodal XRT with WBI
1 of 4
Group 1B Mastectomy: No regional nodal or chestwall XRT
1 of 4
Group 2A lumpectomy: Regional nodal XRT with WBI
1 of 4
Group 2B Mastectomy: Regional nodal XRT and chestwall XRT
1 of 4
Active Control
Experimental Treatment
1636 Total Participants · 4 Treatment Groups
Primary Treatment: regional nodal XRT · No Placebo Group · N/A
Group 2A lumpectomy: Regional nodal XRT with WBIExperimental Group · 2 Interventions: regional nodal XRT, WBI · Intervention Types: Radiation, Radiation
Group 2B Mastectomy: Regional nodal XRT and chestwall XRTExperimental Group · 2 Interventions: regional nodal XRT, chestwall XRT · Intervention Types: Radiation, Radiation
Group 1A Lumpectomy: no regional nodal XRT with WBI
Radiation
ActiveComparator Group · 1 Intervention: WBI · Intervention Types: RadiationGroup 1B Mastectomy: No regional nodal or chestwall XRTNoIntervention Group · 1 Intervention: Group 1B Mastectomy: No regional nodal or chestwall XRT · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WBI
2017
N/A
~140
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from randomization to death from any cause, assessed up to 10 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,127,219 Total Patients Enrolled
52 Trials studying Stage IB Breast Cancer
12,036 Patients Enrolled for Stage IB Breast Cancer
NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
135,366 Total Patients Enrolled
1 Trials studying Stage IB Breast Cancer
3,066 Patients Enrolled for Stage IB Breast Cancer
Radiation Therapy Oncology GroupNETWORK
190 Previous Clinical Trials
63,255 Total Patients Enrolled
Norman Wolmark, MDPrincipal InvestigatorNSABP Foundation Inc
58 Previous Clinical Trials
80,795 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in Breast Cancer (http://www.asco.
You must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.
References
- Ditsch, Nina, Isabel T. Rubio, Maria L. Gasparri, Jana de Boniface, and Thorsten Kuehn. 2020. “Breast and Axillary Surgery in Malignant Breast Disease: A Review Focused on Literature of 2018 and 2019”. Current Opinion in Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/gco.0000000000000593.
- Ditsch N, Rubio IT, Gasparri ML, de Boniface J, Kuehn T. Breast and axillary surgery in malignant breast disease: a review focused on literature of 2018 and 2019. Curr Opin Obstet Gynecol. 2020 Feb;32(1):91-99. doi: 10.1097/GCO.0000000000000593.
- 2013. "Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01872975.
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Conditions
Cancer Related
Treatments