Phase 2 Breast Cancer Trial, Recruiting NCT04115306 Sponsor: Phoenix Molecular Designs Condition: Breast Cancer
Back to Breast Cancer

Phase 2 Breast Cancer Trial, Recruiting

NCT04115306
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:

  • Your tumor tissue (either stored samples or a fresh biopsy) must test positive for a protein called RSK2
  • Your breast cancer must be hormone receptor-positive (HR+) and HER2-negative, confirmed by a tissue or cell sample test
  • Your cancer must not have a specific gene change called an ESR1 mutation (meaning the ESR1 gene is in its normal form)
  • You must have been diagnosed with breast cancer that has either spread to other parts of the body, or is locally advanced in a way that cannot be treated with surgery or radiation to cure it
  • You must be a suitable candidate for hormone-based treatment (endocrine therapy)
  • You must have already received at least one hormone-based treatment for advanced or metastatic breast cancer, or your cancer came back while you were on hormone therapy after earlier treatment
  • You must have stopped your previous hormone therapy at least 15 days before starting this trial
  • You must have at least one area of cancer that can be measured on a scan, following standard measurement guidelines
  • Your cancer must have continued to grow during or after treatment with a CDK4/6 inhibitor drug combined with hormone therapy
  • Your blood, liver, and kidney function must be within acceptable ranges based on lab tests
  • Any side effects from previous treatments must have mostly cleared up before joining (confirm with trial site)

Who may not be able to join:

  • You have previously received chemotherapy
  • Your tumor has an ESR1 gene mutation
  • You have received another experimental or biological therapy within the last 14 days
  • Your cancer has spread to internal organs in a way that is causing a serious, urgent health crisis that would normally require chemotherapy
  • Your cancer has spread to the brain or spinal cord, unless it has been treated and your condition is neurologically stable
  • You have a history of cancer spreading to the membranes surrounding the brain or spinal cord (leptomeningeal metastases)
  • You have an active infection (bacterial, viral, or fungal) that requires ongoing treatment
  • You have a known hepatitis B or hepatitis C infection
  • You are HIV-positive with a low immune cell count (below 350 CD4+ cells) or have had a serious HIV-related infection in the past
  • You have a significant history of heart problems, including an abnormal heart rhythm measurement above a certain level on an ECG (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 30 June 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.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Phoenix Molecular Designs
Registry
ClinicalTrials.gov
Start date
14 November 2019
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and tolerability of PMD-026 in combination with fulvestrant in patients with HR+/HER2- previously treated breast cancer

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: 30 June 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