Image

Breast Re-irradiation After Second Ipsilateral Lumpectomy

Breast Re-irradiation After Second Ipsilateral Lumpectomy

Recruiting
40 years and older
Female
Phase N/A

Powered by AI

Overview

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.

Eligibility

Inclusion 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 available.
  • 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 they are pregnant while participating in this study, they should notify the treating physician immediately.

A person able to become pregnant is any person assigned female at birth (regardless of gender identity, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  1. Has not undergone a hysterectomy or bilateral oophorectomy; or
  2. 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)

Exclusion Criteria:

  • 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 primary tumor information will be recorded as missing on the clinical forms.
  • 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.

Study details
    Breast Cancer
    Cancer
    Cancer of the Breast
    HER2-negative Breast Cancer
    ER+ Breast Cancer
    Estrogen-receptor-positive Breast Cancer

NCT06867484

Youssef Zeidan

1 February 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.