Shortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men With Node-positive and High-risk Node-negative Invasive Breast Cancer

Part of paid clinical trials in Loveland, Colorado.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07076485
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultrahypofractionated Radiation — RADIATION
    Given by infusion
  • Moderately Hypofractionated Radiation — RADIATION
    Given by infusion

Study Details

To learn about the effects of shorter RNI regimens in patients with breast cance who have had a lumpectomy or mastectomy and who are at higher risk for lower risk for the disease returning.

Key Dates

Start date
Aug 19, 2025
Status verified
May 2026
Primary completion
Jan 1, 2029
Completion
Jan 1, 2031

Study Design

Enrollment
768 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: High-Risk Lumpectomy Cohort Arm 1: Moderately Hypofractionated Breast+RNI with SIB
  • Other: High-Risk Lumpectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI with Sequential Boost
  • Experimental: High-Risk Mastectomy Cohort Arm 1: Moderately Hypofractionated Chest Wall+RNI with SIB
  • Other: High-Risk Mastectomy Cohort Arm 2: Moderately Hypofractionated Chest Wall+RNI with Sequential Boost
  • Experimental: Low-Risk Lumpectomy Cohort Arm 1: Ultrahypofractionated Breast+RNI with SIB
  • Other: Low-Risk Lumpectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI with SIB
  • Experimental: Low-Risk Mastectomy Cohort Arm 1: Ultrahypofractionated Chest Wall+RNI
  • Other: Low-Risk Mastectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Northern ColoradoLovelandColorado80538
Supriya Jain, MD
[email protected]
Supriya Jain, MD (PRINCIPAL_INVESTIGATOR)
Cooper Hospital University Medical CenterVoorhees TownshipNew Jersey08103
Anthony Dragun, MD
[email protected]
855-632-2667
Anthony Dragun, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Benjamin Smith, MD
[email protected]
713-563-2380
Benjamin Smith, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Shraddha Dalwadi, MD, MBA
[email protected]
210-567-1203
Shraddha Dalwadi, MD, MBA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Loveland, CO

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Banner MD Anderson Northern Colorado· Loveland, COCooper Hospital University Medical Center· Voorhees Township, NJThe University of Texas M. D. Anderson Cancer Center· Houston, TXUniversity of Texas Health Science Center at San Antonio· San Antonio, TX

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