An interventional study of VENUS SHELL™ immobilization device in Invasive Breast Cancer Early Stages and Ductal Carcinoma In Situ, DCIS, sponsored by HeroSupport SA. Recruiting at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by HeroSupport SA · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States — 31 open to participants now, 51 under way, 6 of them phase 3. Carcinoma, Intraductal, Noninfiltrating · United States.
Among the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, this one is the 112th largest by planned enrollment of the 171 interventional ones that give a count, is one of 3 that started in 2026, is one of 65 with no phase, reaches primary completion later than 26 of the 50 other live ones, and was the 210th registered.
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
Browse Carcinoma, Intraductal, Noninfiltrating studies →31 of the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States are open now. Recruiting first, the newest first:
Providence Health & Services · Sites in United States
Ages 18+
University of Florida · Sites in United States
Ages 18+
Barbara Ann Karmanos Cancer Institute · Sites in United States
Ages 18+ · Women only
National Cancer Institute (NCI) · Sites in United States
Ages 45–74 · Women only · Healthy volunteers
University of Utah · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 42 Carcinoma, Intraductal, Noninfiltrating studies recruiting now, 33 (79%) set no upper age limit and 5 (12%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 40 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
210 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 31 · Phase 2 68 · Phase 3 15 · Phase 4 1
First in 1991; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 66 across 208 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Median enrollment 51 across the 171 interventional studies, 109 across the 38 observational. Of the 140 that completed or were terminated, 59 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 210 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with HeroSupport SA as lead sponsor.
HeroSupport SA has 1 study filed under Carcinoma, Intraductal, Noninfiltrating — fewer than ten, so there is no comparison to draw.
15 of the studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04722692Phase 3Uppsala UniversityDelayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ | 2026-12-30 |
| NCT03546972M.D. Anderson Cancer CenterDiabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants | 2026-11-30 |
| NCT03909282Stanford UniversitySurgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma | 2026-12 |
| NCT03448926PreludeDxThe PREDICT Registry: | 2026-12 |
| NCT05340673City of Hope Medical CenterComparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer | 2026-12-15 |
Add all 15 to your calendar (.ics) → With an account.
Among the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to find out whether using a personalized breast holder (called VENUS SHELL™) can improve positioning and patient comfort during prone radiotherapy (radiotherapy given while the patient lies on her stomach).
The main goals of the study are:
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For invasive breast cancer only:
For ductal carcinoma in situ only:
EXCLUSION Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VENUS SHELL™ is used for radiotherapy planning and radiotherapy tratment (Accelerated Partial Breast Radiotherapy)
Device: VENUS SHELL™ immobilization device
VENUS SHELL™ is used for Accelerated Partial Breast Irradiation
Feasibility outcome: Time (days) between surface scan data received by HeroSupport and arrival of the VENUS SHELL™ at the clinical site
Time frame: Treatment set-up (up to 21 days)
Performance outcomes: radiotherapy delivered within 15 minutes timeslot and patient positioning accuracy within 2 mm
Radiotherapy time includes patient positioning and treatment. Patient positioning accuracy is measured though displacement via Tattoos and Image-Guided Radiation Therapy imaging
Time frame: Study treatment (10 days)
Safety outcome: number of medical device-related Adverse Events as assessed by CTCAE v5.0
Time frame: Through study completion (an average of 3 months)
Patients' comfort (questionnaires)
A first set of questions is rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). A second set of questions is rated on a 4-point scale ranging from 1 (not at all) to 4 (very).
Time frame: Treatment set-up (up to 21 days) and study treatment (10 days)
Evaluate ease of use and overall satisfaction of using the VENUS SHELL (questionnaires)
A set of questions rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Time frame: Study treatment (10 days)
In-vivo dosimetry measured with thermoluminescent dosimeters (TLDs)
Comparison between expected and measured dose to the skin
Time frame: Radiotherapy treatment first session, up to last session (10 days)
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 47 interventional studies with no phase under Carcinoma, Intraductal, Noninfiltrating, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 134. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Intraductal, Noninfiltrating →