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SAPPHIRe-II: Shorter Radiation for Breast Cancer

This study, called SAPPHIRe-II, is testing if shorter schedules of radiation therapy are as safe and effective for people with breast cancer. It's for women and men who have had surgery (lumpectomy or mastectomy) and whose cancer has spread to lymph nodes, or who have a high risk of their cancer returning. The study compares two types of radiation: Ultrahypofractionated Radiation and Moderately Hypofractionated Radiation. Researchers will look at side effects, how well the treatment controls the cancer, and how it affects your quality of life. The study aims to enroll 768 participants and is currently unclear about its recruitment status.

Study design
This is a randomized, multi-center, Phase II study planning to enroll 768 participants. It compares two different radiation schedules for breast cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07076485

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~768 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Ultrahypofractionated RadiationModerately Hypofractionated Radiation

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

4 sites across 3 states
Texas2
Colorado1
New Jersey1

Study leadership

  • Benjamin Smith, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Benjamin Smith, MD
[email protected]
(713) 563-2380
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

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