Phase 2 Breast Cancer Trial, Recruiting NCT07016399 Sponsor: Vandana Abramson Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT07016399
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:

  • You are 18 years of age or older
  • You have signed (or are willing to sign) a consent form and understand what taking part in the study involves
  • You are generally healthy enough to carry out daily activities with little or no limitation (this is measured by a standard medical scale called ECOG, scores 0 or 1)
  • You have been newly diagnosed with breast cancer that has been confirmed by a tissue sample (biopsy), and your cancer tests show: very low levels of estrogen and progesterone receptors (less than 10%), no HER2 gene amplification, and high levels of androgen receptor (80% or more)
  • Your tumor is at least 1 cm in size, or is at a stage where treatment before surgery (neoadjuvant treatment) is appropriate
  • Your blood test results taken within 28 days before starting treatment show that your blood cell counts, kidney function, liver function, and calcium levels are all within acceptable ranges (confirm specific values with trial site)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment and agree to use reliable contraception during the study and for at least 120 days after treatment ends
  • If you are a woman, you must agree not to breastfeed during treatment and for at least 120 days after treatment ends
  • If you are a man who could father children, you must agree to use reliable contraception during the study and for at least 120 days after treatment ends, and avoid donating sperm for at least 120 days after treatment ends

Who may not be able to join:

  • Your breast cancer cannot be surgically removed, or the cancer has spread to other parts of the body
  • You have had another type of cancer in the past 5 years, unless it was a very low-risk cancer that was fully treated and cured (such as certain skin cancers or early-stage cervical changes)
  • You are currently pregnant or breastfeeding
  • You have moderate to severe liver disease (confirm with trial site)
  • You are currently taking part in another clinical trial involving an experimental treatment, or have done so within the past 4 weeks (those in a follow-up phase of a previous trial may still be eligible — confirm with trial site)
  • You have previously received an organ or tissue transplant from another person
  • You have had a severe allergic reaction to any of the study drugs used in this trial (confirm specific drugs with trial site)
  • You have a significant heart condition, such as heart failure, uncontrolled abnormal heart rhythms, unstable chest pain, or a history of heart attack; or you have had a stroke or mini-stroke (TIA) in the past 6 months
  • You have an uncontrolled ongoing infection, serious illness, or a mental health or personal situation that would make it difficult to follow the study requirements
  • You have a known medical condition that means you cannot safely receive a type of cancer treatment called a checkpoint inhibitor (confirm with trial site)

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 8 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.

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Vandana Abramson
Registry
ClinicalTrials.gov
Start date
9 September 2025
Est. completion
1 September 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean ΔKi-67 level

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: 8 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