Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer

This phase II trial tests how well tamoxifen and pegylated liposomal doxorubicin works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that has spread to nearby tissue or lymph nodes (locally advanced) and is unable to be operated on (inoperable). Tamoxifen works by blocking the effects of estrogen in the breast. This may help stop the growth of tumor cells that need estrogen to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA an

Trial Details

NCT ID

NCT06434064

Phase

PHASE2

Sponsor

Roswell Park Cancer Institute

Status

RECRUITING

Cancer Type

Triple Negative (TNBC) Breast Cancer

Interventions

Biopsy
Biospecimen Collection
Computed Tomography
Echocardiography
Magnetic Resonance Imaging
Pegylated Liposomal Doxorubicin Hydrochloride

Locations (sample)

Buffalo, New York, United States|42.88645,-78.87837

Key Eligibility Criteria

Patients with pathologically confirmed metastatic triple negative breast cancer (ER ≤ 10%) that have been previously treated with at least 2 lines …
Patients must have a confirmed eligible TP53 genomic alteration, as determined by the Roswell Park Oncomine™ Precision Assay (OPA) or similar CLIA-…
Patients must have ERα (estrogen receptor alpha) and PgR (progesterone receptor) status assessed using current American Society of Clinical Oncolog…
The tumor must be HER-2 negative by immunochemistry (IHC) 0-1+ or IHC 2 + and fluorescence in situ hybridization (FISH) negative

For full eligibility, visit ClinicalTrials.gov.

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