DE-iPTV radiotherapy for breast cancer that has spread to the brain in patients not eligible for SRS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to determine the feasibility of delivering dose-escalated internal PTV radiotherapy (DE-iPTV) to brain metastases from breast cancer in patients who are not suitable for stereotactic radiotherapy. Participants will receive five radiotherapy fractions and complete weekly health-related quality of life assessments plus steroid diaries, with MRI follow-up at 8, 12, and 24 weeks. An exploratory biomarker component is included. The study also investigates the impact of DE-iPTV on lesion control, patient quality of life, and steroid use, comparing outcomes to the expected course with conventional WBRT. Eligible participants are adults in the UK with confirmed brain metastases, preserved performance status, and life expectancy over 3 months.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
2. Adult (aged 16+) patients, resident in the United Kingdom.
3. Histologically confirmed primary breast cancer with brain metastases on MRI imaging
4. The treating oncologist considers whole-brain radiotherapy to be the most suitable treatment outside of the trial.
5. Eastern Cooperative Oncology Group Performance status 0, 1 or 2
6. Able to respond to question about their quality of life, symptoms, and side effects remotely (via telephone assessments
7. Life expectancy from extra-cranial disease \>3 months

Exclusion Criteria

1. Leptomeningeal disease
2. "Miliary" pattern of metastases: patients with over 15 metastases are excluded (clinician-based assessment)
3. Cystic metastases
4. Previous whole or partial brain radiotherapy (previous surgery or SRS is acceptable)
5. Plan for hippocampal-sparing whole brain radiotherapy.
6. Unable to give informed consent.
7. Prognosis less than 3 months
8. Pregnant or nursing women
9. Unable to complete a brain MRI and/or known allergy to gadolinium.

Where it's running

• Imperial College London
  London, London, United Kingdom Recruiting
• University of Oxford Cancer and Haematology Centre | Churchill Hospital Headington, Oxford,
  Oxford, United Kingdom Recruiting

Study contacts

• Study coordinator: Lillie Pakzad-Shahabi, BSc MSc
• Email: beat-breast@imperial.ac.uk
• Phone: 02033118427

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using silibinin to prevent brain metastasis recurrence in lung and breast cancer patients

  This study is testing if a medication called silibinin can help prevent brain cancer from coming back in patients who have had surgery for lung or breast cancer.

  Recruiting at 2 sites A.O.U. Città della Salute e della Scienza · Genova and 5 other locations · NCT05689619

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

• Different skin care approaches to prevent skin reactions after mastectomy radiation

  This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07918989

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.