NCT07076485

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
768

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
56mo left

Started Aug 2025

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Aug 2025Jan 2031

First Submitted

Initial submission to the registry

July 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

August 19, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3.4 years

First QC Date

July 15, 2025

Last Update Submit

May 19, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (8)

High-Risk Lumpectomy Cohort Arm 1: Moderately Hypofractionated Breast+RNI with SIB

EXPERIMENTAL
Radiation: Moderately Hypofractionated Radiation

High-Risk Lumpectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI with Sequential Boost

OTHER
Radiation: Moderately Hypofractionated Radiation

High-Risk Mastectomy Cohort Arm 1: Moderately Hypofractionated Chest Wall+RNI with SIB

EXPERIMENTAL
Radiation: Moderately Hypofractionated Radiation

High-Risk Mastectomy Cohort Arm 2: Moderately Hypofractionated Chest Wall+RNI with Sequential Boost

OTHER
Radiation: Moderately Hypofractionated Radiation

Low-Risk Lumpectomy Cohort Arm 1: Ultrahypofractionated Breast+RNI with SIB

EXPERIMENTAL
Radiation: Ultrahypofractionated Radiation

Low-Risk Lumpectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI with SIB

OTHER
Radiation: Moderately Hypofractionated Radiation

Low-Risk Mastectomy Cohort Arm 1: Ultrahypofractionated Chest Wall+RNI

EXPERIMENTAL
Radiation: Ultrahypofractionated Radiation

Low-Risk Mastectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI

OTHER
Radiation: Moderately Hypofractionated Radiation

Interventions

Ultrahypofractionated RadiationRADIATION

Given by infusion

Low-Risk Lumpectomy Cohort Arm 1: Ultrahypofractionated Breast+RNI with SIBLow-Risk Mastectomy Cohort Arm 1: Ultrahypofractionated Chest Wall+RNI
Moderately Hypofractionated RadiationRADIATION

Given by infusion

High-Risk Lumpectomy Cohort Arm 1: Moderately Hypofractionated Breast+RNI with SIBHigh-Risk Lumpectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI with Sequential BoostHigh-Risk Mastectomy Cohort Arm 1: Moderately Hypofractionated Chest Wall+RNI with SIBHigh-Risk Mastectomy Cohort Arm 2: Moderately Hypofractionated Chest Wall+RNI with Sequential BoostLow-Risk Lumpectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI with SIBLow-Risk Mastectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligibility Criteria Applicable to All Cohorts
  • Histologically confirmed invasive breast cancer (nodal involvement from presumed invasive breast cancer in the setting of occult breast cancer is sufficient to meet this criteria)
  • \. Regional nodal irradiation recommended by treating radiation oncologist. 2 Negative final surgical margins. 3 No more than 12 weeks have elapsed since final breast/lymph node surgery for patients treated with surgery alone or neoadjuvant chemotherapy. No more than 12 weeks have elapsed since final cytotoxic chemotherapy for patients who received adjuvant chemotherapy. 5. Age ≥18 years. Because breast cancer is exceedingly rare in patients \< 18 years of age, children are excluded from this study. 6. Patients with a prior or concurrent malignancy are eligible provided that the natural history and treatment of the prior or concurrent malignancy does not interfere with the safety or efficacy assessment of the investigational radiation regimen used in this trial. 7. Ability to understand and the willingness to sign a written informed consent document. 8. Concurrent enrollment on other observational, translational, or therapeutic studies is allowed provided there is no direct conflict between the other protocol and the radiation regimen proscribed in this trial.
  • Eligibility Criteria for the Low-Risk Lumpectomy Cohort
  • For patients treated with upfront surgery, pathologic stage pT0-T4b N0-N3a breast cancer without infraclavicular or internal mammary nodal involvement.
  • For patients treated with neoadjuvant chemotherapy, clinical stage cT0-T4b N0-N2a breast cancer.
  • Treated with lumpectomy (or axillary surgery only in the case of occult primary breast cancer)
  • No nodal boost recommended by the treating radiation oncologist.
  • Eligibility Criteria for the High-Risk Lumpectomy Cohort
  • Treated with neoadjuvant chemotherapy
  • Clinical stage cT0-T4b N1-N3a/b/c
  • Treated with lumpectomy (or axillary surgery only in the case of occult primary breast cancer)
  • Nodal boost recommended by the treating radiation oncologist.
  • Eligibility Criteria for the Low-Risk Mastectomy Cohort
  • For patients treated with upfront surgery, pathologic stage T0-T2 N0-N2a
  • +20 more criteria

You may not qualify if:

  • History of therapeutic radiation overlapping with the index breast or nodal basins that require radiation therapy.
  • History of scleroderma
  • Pregnant women are excluded from this study because ionizing radiation has the potential for teratogenic or abortifacient effects.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Banner MD Anderson Northern Colorado

Loveland, Colorado, 80538, United States

RECRUITING

Cooper Hospital University Medical Center

Voorhees Township, New Jersey, 08103, United States

RECRUITING

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Benjamin Smith, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Smith, MD

CONTACT

(713) 563-2380bsmith3@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 22, 2025

Study Start

August 19, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2031

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations

US(4)