Personalized breast positioning to speed and improve prone radiotherapy
Official title: Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery
Run by HeroSupport SA · NCT07711847 · Data updated 2026-11-12
This trial tests whether a personalized VENUS SHELL immobilizer helps patients with early breast cancer or DCIS receive precise radiotherapy more comfortably while lying face down.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | HeroSupport SA Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | July 2, 2026 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT07711847 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with early-stage invasive breast cancer or DCIS who had upfront breast-conserving surgery and are planed for radiotherapy within 12 weeks, with favorable performance status.
✕Probably not a fit
Patients for whom the VENUS SHELL™ does not improve positioning or comfort or for whom treatment changes negate its use may not see benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study evaluates the safety and effectiveness of a custom VENUS SHELL immobilization device used during prone radiotherapy for early-stage invasive breast cancer and DCIS. Participants will have a breast surface scan to create their personalized shell, then use it during planning and treatment, with questionnaires on comfort. The goal is to determine if the device improves radiation accuracy and patient experience without added risks. The study is conducted at participating centers with adults 40 and older meeting specific tumor and surgical criteria.
Why it matters
Potential benefit: If successful, patients may experience more accurate radiation delivery with greater comfort during prone treatment.
How similar studies have gone: Previous studies of personalized immobilization in radiotherapy have shown improved setup accuracy in some settings, but this approach is relatively novel for prone breast radiotherapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
INCLUSION Criteria: * Written informed consent according to ICH/GCP regulations before registration and prior to any study-specific procedures * Upfront breast conservative surgery * Radiotherapy planned within 12 weeks after surgery * ECOG/WHO performance status ≤2 * Age ≥40 year For invasive breast cancer only: * Staging pT1-T2, N0M0 (Tumor size ≤3 cm) * If no sentinel lymph node biopsy performed, patient must be clinically N0 * Negative margins (no tumor on ink) For ductal carcinoma in situ only: * Staging pTis (tumor size ≤3 cm) * Negative margins (≥2 mm) EXCLUSION Criteria: * Patient of male sex * Inability to obtain informed consent or adhere to the CIP * Breast skin damage that could prevent VENUS SHELL™ usage according to protocol timeline (e.g. presence of any skin or soft tissue wound that failed to show evidence of progression towards healing, clinical signs of active infection at or immediately adjacent to the intended intervention site, etc.) * Known germline BRCA1/2 mutation * Unable to lay prone * Unable to undergo imaging by CT scan * Documented hypersensitivity or allergy to medical plasters, acrylonitrile butadiene styrene * Any serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may affect patient compliance or place the patient at high risk within the study. * Pregnancy or breast feeding * Claustrophobia * Patient with a body weight exceeding 120 kg * Patient with pendulous breasts that come into contact with the CT table, preventing adequate space for shell usage * Presence of any cardiac implantable electronic device (CIED), including but not limited to a pacemaker, implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device, or other electronically active implant.
Where it's running
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NYU Grossman School of Medicine
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Naamit Gerber, MD — NYU Langone Health
- Study coordinator: Giovanna Dipasquale
- Email: giovanna@herosupport.ch
- Phone: +41(0)783349987
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Omitting post-surgery radiotherapy for young women with low-risk DCIS after breast-conserving surgery
In young women with small, low-risk DCIS treated with lumpectomy, doctors are testing whether skipping postoperative radiotherapy is safe and see if close follow-up is enough.
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Omission of Radiotherapy After Breast-Conserving Surgery for Certain DCIS Patients
This trial tests whether skipping postoperative radiotherapy is okay for women with low- or intermediate-risk DCIS after breast-conserving surgery.
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Long-term follow-up of early stage breast cancer patients
This study is tracking early-stage breast cancer patients for about 30 years after their treatment to see how well the treatments work and what long-term effects they might have.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.