Phase 2 Breast Cancer Trial, Recruiting NCT05837455 Sponsor: Washington University School of Medicine Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT05837455
Recruiting Phase 2

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 newly diagnosed with stage II or III breast cancer that tests positive for estrogen receptors (ER) and negative for HER2, where the goal of treatment is to have surgery to fully remove the cancer after initial drug treatment.
  • People whose tumor is either at least 2 cm in size with no confirmed spread to nearby lymph nodes, or at least 10 mm in size with confirmed spread to nearby lymph nodes that can be surgically removed.
  • People who are in good general health, rated as fully active or able to carry out light work (confirm with trial site).
  • People whose treating doctor considers them suitable to receive a hormone-blocking medication called an aromatase inhibitor before surgery.
  • People whose treating doctor considers them suitable to receive standard chemotherapy (containing anthracycline and/or taxane medicines) before surgery.
  • People who are able to have a breast MRI scan with an injected contrast dye and can complete the required screening form.
  • People who have healthy enough bone marrow and organ function, as determined by their treating doctor.
  • People with a past hepatitis C infection are eligible, provided they have been treated and are cured.
  • People who are at least 18 years old.
  • People who are postmenopausal, defined as one of the following: aged 60 or older; aged under 60 with a uterus still present and no menstrual period for 12 or more consecutive months; or having had both ovaries or the entire uterus surgically removed.
  • People who are willing and able to give written informed consent and attend scheduled visits and treatments.

Who may not be able to join:

  • People who have inflammatory breast cancer (a specific aggressive type affecting the skin of the breast).
  • People whose cancer has come back locally or has spread to other parts of the body.
  • People who have cancer in both breasts.
  • People who have already received systemic treatment (such as chemotherapy or hormone therapy) for this breast cancer.
  • People who already have moderate or severe nerve damage (numbness, tingling, or pain in hands or feet) before starting the trial.
  • People with a serious ongoing illness that would make it difficult to follow the trial requirements.
  • People who have had another cancer within the past 5 years, with some exceptions — such as certain treated skin cancers, treated early-stage cervical changes, or another cancer that the trial's lead doctor determines would not affect the safety or results of this trial.
  • People who are currently taking part in another clinical trial testing a treatment for breast cancer.
  • People who are HIV positive and whose treating doctor believes this would make chemotherapy unsafe for them.
  • People who have had a serious allergic reaction to any medicines similar to those used in this trial, including anastrozole, taxane chemotherapy drugs, anthracycline chemotherapy drugs, or cyclophosphamide.
  • People with an active, uncontrolled infection that requires intravenous antibiotics, antivirals, or antifungal medicines within 7 days before starting the trial treatment (people taking antibiotics as a routine preventive measure may still be eligible).
  • People with any other uncontrolled medical condition that the investigator believes could put them at risk or affect the trial results.

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 23 July 2026
Phase 2: approximately ~30% 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: Nusayba Bagegni, M.D., Washington University School of Medicine

Phone: 314-273-3022

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 2
Registry
ClinicalTrials.gov
Start date
30 May 2024
Est. completion
30 November 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective response rate (ORR) by breast MRI in the combined low-risk plus high-risk endocrine-sensitive groups (pooled endocrine therapy-responders)

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: 23 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