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New treatment option for Breast Cancer
Official title 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
ClinicalTrials.gov ID: NCT07076485
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility Criteria Applicable to All Cohorts Histologically confirmed invasive breast cancer (nodal involvement from presumed invasive breast...
- For patients treated with upfront surgery, pathologic stage pT0-T4b N0-N3a breast cancer without infraclavicular or internal mammary nodal...
- 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
You likely can't join 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
See the full eligibility criteria
- 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...
- 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
- For patients treated with neoadjuvant chemotherapy, clinical stage T0-T3 N0- N2a
- For patients treated with neoadjuvant chemotherapy, residual cellularity of primary tumor ≤ 20%.
- Treated with mastectomy
- Negative surgical margins ≥ 2 mm.
- No or only focal lymphovascular space invasion.
- Age ≥ 40 years
- Chest wall boost NOT recommended by treating radiation oncologist. Eligibility Criteria for High-Risk Mastectomy Cohort
- For patients treated with upfront surgery, pathologic stage T0-T4d N0-N3c
- For patients treated with neoadjuvant chemotherapy, clinical stage T0-T4d N0- N3c
- Treated with mastectomy
- Chest wall boost and/or nodal boost recommended by treating radiation oncologist Pregnancy Status (applicable to all cohorts) Therapeutic radiation is known to be teratogenic. As a result, women of child-bearing...
- 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. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Loveland, Colorado, United States
- Voorhees Township, New Jersey, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loveland, Colorado, United States; Voorhees Township, New Jersey, United States; Houston, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.