Phase 3 Breast Cancer Trial, Recruiting NCT01185132 Sponsor: Rocky Mountain Cancer Centers Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT01185132
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been confirmed by laboratory testing to have early-stage breast cancer or a non-invasive breast condition (such as DCIS), where the disease is small, localised, and has not spread to lymph nodes or other parts of the body.
  • People whose cancer or area of concern, if found in more than one small spot, measures no more than 3.0 cm across in total.
  • People whose surgeon was able to remove the cancer with a clear border of healthy tissue of at least 0.2 cm around it.
  • People with certain cancer types (lobular breast cancer or high-grade DCIS) who have had an MRI scan as part of their initial assessment to confirm the disease is localised.
  • People with DCIS who had an MRI scan before their lumpectomy (cancer removal surgery).
  • People where any suspicious areas seen on MRI that were outside the planned surgery area have been further checked by ultrasound or biopsy to rule out disease in other areas of the breast.
  • People who had cancerous calcium deposits visible on mammogram and have had a follow-up mammogram after surgery confirming those deposits were fully removed.
  • People willing to complete additional screening steps as outlined in the trial's protocol.
  • People who have had small marker clips (called fiducial markers) successfully placed in the breast to guide radiation treatment, and where those markers stay in position without moving.
  • People where the area to be treated with radiation makes up no more than 25% of the affected breast.
  • People for whom radiation treatment is planned to start within 10 weeks of their surgery.

Who may not be able to join:

  • People who are pregnant or breastfeeding.
  • People who have a connective tissue disorder (a condition affecting collagen in the body, such as lupus or scleroderma).
  • People whose surgery did not achieve a clear enough border of healthy tissue around the cancer (less than 0.2 cm).
  • People who still have suspicious or cancerous calcium deposits remaining after surgery.
  • People whose cancer is found in clearly separate, distinct areas of the breast, or where microscopic disease spans more than 3.0 cm.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Charles Leonard, MD, Rocky Mountain Cancer Centers

Phone: 303-418-7607

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Rocky Mountain Cancer Centers
Registry
ClinicalTrials.gov
Start date
1 July 2009
Est. completion
1 July 2018

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI); Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov