Phase 1 Breast Cancer Trial, Recruiting NCT06638307 Sponsor: Stemline Therapeutics, Inc. Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Recruiting

NCT06638307
Recruiting Phase 1

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 have advanced breast cancer (either spread to other parts of the body, or returned in the local area) that cannot be cured.
  • Your tumor has been tested and shows specific genetic changes in certain genes called PIK3CA, AKT1, or PTEN.
  • You have previously received at least one hormone-based (endocrine) therapy for your advanced or metastatic breast cancer, OR your cancer came back or got worse during or within 12 months of finishing hormone therapy after your initial treatment.
  • Your cancer got worse while you were taking a specific type of treatment called a CDK4/6 inhibitor (such as palbociclib, ribociclib, or abemaciclib) combined with a hormone therapy called fulvestrant or an aromatase inhibitor.

Who may not be able to join:

  • You have cancer that has recently spread to your brain or spinal cord, or this is an active, ongoing problem.
  • Your cancer has spread widely to internal organs and is causing serious, potentially life-threatening symptoms in the near term — for example, large uncontrolled fluid build-up in the abdomen, lungs, or around the heart, cancer spreading through the lymph vessels in the lungs, or more than half of your liver being affected.
  • You still have significant side effects from previous radiation treatment that have not improved to a mild level, with the exception of hair loss or mild-to-moderate nerve-related symptoms such as tingling or numbness (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 21 July 2026
Phase 1: approximately ~10% 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

Phone: 1-877-332-7961

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 1
Sponsor
Stemline Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
25 October 2024
Est. completion
24 October 2027

Where this trial is recruiting

🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312; Recommended Phase 2 Dose (RP2D) of MEN2312

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: 21 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