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New treatment option for Breast Cancer
Official title Breast Re-irradiation After Second Ipsilateral Lumpectomy
ClinicalTrials.gov ID: NCT06867484
What this study is testing
- What it's testing
- The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- Diagnosed with ER+HER2- breast cancer
- Provision of signed and dated ICF
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 40 years
- Oncotype \< 26 (postmenopausal) \<16 (premenopausal), Low, or Ultra-Low index.
You likely can't join if
- BRCA1/2 mutation or any other receptor subtypes
- Individuals assigned male at birth with breast cancer
- Pregnancy or breastfeeding
- Skin involvement
- Distant metastasis
- Patients with initial high-risk triple negative or HER-2 enriched breast cancer will be excluded from the trial. However, if the initial subtype is...
See the full eligibility criteria
- Diagnosed with ER+HER2- breast cancer
- Provision of signed and dated ICF
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 40 years
- Oncotype \< 26 (postmenopausal) \<16 (premenopausal), Low, or Ultra-Low index.
- Minimum interval of 18 months from last breast radiotherapy session.
- Prior radiation therapy in the form of brachytherapy, external beam MV photons, protons or intraoperative radiation are allowed with an upper total dose limit of 68 Gy (EQD2) for those patients with prior records...
- Ipsilateral recurrence, unifocal \< 3 cm with negative margins, N0, Tis and invasive (pathological staging)
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Planning target volume: whole breast (PTV: WB) ratio \< 1/2
- Life expectancy \> 12 months
- Individuals able to become pregnant: agreement to use highly effective contraception starting at screening through treatment, and for 1 year after the end of PBI. Should a participant become pregnant or suspect that...
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time during the preceding 12 consecutive months)
- BRCA1/2 mutation or any other receptor subtypes
- Individuals assigned male at birth with breast cancer
- Pregnancy or breastfeeding
- Skin involvement
- Distant metastasis
- Patients with initial high-risk triple negative or HER-2 enriched breast cancer will be excluded from the trial. However, if the initial subtype is not known, patients will still be allowed to enroll, and the initial...
- Other malignancies (except skin)
- Connective tissue disorder (e.g., scleroderma, lupus)
- Any other condition that may put a participant at higher risk, at the discretion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Boca Raton, Florida, United States
- Miami, Florida, 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 female, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boca Raton, Florida, United States; Miami, Florida, 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.