Phase 3 Breast Cancer Trial, Recruiting NCT04261244 Sponsor: Bielefeld University Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT04261244
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 a tissue test (biopsy) to have invasive breast cancer in one breast only
  • People for whom radiation therapy has been recommended
  • People for whom chemotherapy before surgery (which may include antibody treatment or other targeted therapies) has been recommended, in line with standard medical guidelines
  • People who are female
  • People who have signed the official consent form for the trial
  • People with any hormone receptor or HER2 status (no restrictions apply to these test results)
  • People with any tumour grade (G1, G2, or G3)
  • People aged 18 or older at the time of signing the consent form
  • People with a general health/activity level rated at 2 or below on a standard medical scale (confirm with trial site)
  • People with no existing health conditions that would prevent treatment

Who may not be able to join:

  • People whose only planned pre-surgery treatment is hormone therapy (without chemotherapy)
  • People who have breast cancer in both breasts
  • People who are pregnant or breastfeeding
  • People who have previously had radiation therapy to the chest area
  • People who have a connective tissue disease, such as rheumatoid arthritis or a condition involving blood vessel inflammation (thromboangiitis obliterans)
  • People who have an existing, symptomatic chronic lung condition, such as lung scarring (fibrosis), dust-related lung disease, severe lung conditions caused by allergies (such as farmer's lung), severe emphysema, or advanced COPD
  • People with certain heart conditions, including symptomatic coronary heart disease, a previous heart attack, heart failure of a certain severity, or who have a pacemaker or implanted defibrillator (confirm severity levels with trial site)
  • People who have or have had another cancer, except for a specific type of skin cancer (basalioma) or non-invasive cancers that have fully cleared
  • People whose cancer has spread to distant parts of the body (metastasis)
  • People who have nerve problems affecting the arm on the same side as the affected breast
  • People who have shoulder stiffness on the same side as the breast cancer, regardless of the cause (for example, following an injury)
  • People who have moderate to severe arm swelling (lymphoedema rated grade II or higher) on the same side as the breast cancer
  • People with other medical conditions that would prevent them from safely receiving pre-surgery radiation therapy, including an expectation that they would not be able to follow the treatment plan
  • People who are male
  • People who have already had an assessment of how their cancer responds to chemotherapy

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 26 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: Christiane M Prof., MD Prof., Bielefeld University

Phone: +495215812901

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
Bielefeld University
Registry
ClinicalTrials.gov
Start date
1 February 2024
Est. completion
31 March 2028

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

disease free survival (DFS):

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: 26 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