regional nodal XRT for Stage IB Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stage IB Breast Cancer+1 Moreregional nodal XRT - Radiation
Eligibility
18+
Female
What conditions do you have?
Select

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

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

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: Radiation
Group 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.