Dual-target therapy blocking PI3K/AKT and nitric oxide pathways for metaplastic breast cancer

A phase II multi-center trial evaluating dual targeting of the PI3K/AKT and NOS pathways for treating metaplastic breast cancer (MpBC)

NIH-funded research Methodist Hospital Research Institute · NIH-11168890

This trial tests a combination treatment that blocks the PI3K/AKT and nitric oxide (NOS) pathways for people with metaplastic breast cancer.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionMethodist Hospital Research Institute NIH-funded
Lab location1 site (Houston, United States)
Project IDNIH-11168890 on NIH RePORTER

What this research studies

If you have metaplastic breast cancer, this phase II, multi-center trial is testing a combination therapy that targets two cancer-driving pathways: PI3K/AKT and NOS. The study pairs a pan-NOS inhibitor (L-NMMA), which showed promise in prior triple-negative breast cancer work, with a drug that inhibits the PI3K/AKT pathway. Participants will receive the combination therapy at study sites, have regular scans and exams to track tumor response, and may undergo biopsies and safety monitoring. The research team aims to see if hitting both pathways together can produce better tumor shrinkage and outcomes than current chemotherapy options.

Who could benefit from this research

Good fit: Ideal candidates are adults with confirmed metaplastic breast cancer, especially those with advanced or metastatic disease who have progressed on or are not candidates for standard chemotherapy.

Not a fit: People without metaplastic breast cancer, patients who cannot tolerate the study drugs, or those whose tumors lack PI3K/AKT or NOS pathway activity may not receive benefit.

Why it matters

Potential benefit: If successful, the combination could shrink tumors and improve response and survival for people with metaplastic breast cancer.

How similar studies have performed: A prior clinical trial showed NOS inhibition with L-NMMA had promise in triple-negative breast cancer, while the specific combination with PI3K/AKT blockade in metaplastic breast cancer is a novel approach.

Where this research is happening

Houston, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Breast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.