RecruitingPhase 2NCT06434064

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

A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer


Sponsor

Roswell Park Cancer Institute

Enrollment

30 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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 and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving tamoxifen and pegylated liposomal doxorubicin together may work better in treating patients with metastatic or inoperable, locally advanced triple negative breast cancer than giving either of these drugs alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of tamoxifen (a hormone-blocking drug) and a type of chemotherapy delivered in a fat-based shell (pegylated liposomal doxorubicin) for people with triple-negative breast cancer that has spread or cannot be surgically removed and has stopped responding to at least two previous treatments. **You may be eligible if...** - You have triple-negative breast cancer (ER ≤10%) that has spread to other parts of the body or cannot be removed with surgery - You have been treated with at least 2 prior lines of therapy for metastatic disease - Your tumor has been confirmed to carry a specific mutation in the TP53 gene by an approved genetic test - Your estrogen and progesterone receptor status has been assessed according to current guidelines - Your general health allows you to receive chemotherapy **You may NOT be eligible if...** - You do not have the specific TP53 gene alteration - You have uncontrolled heart problems, serious infections, or other significant medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREEchocardiography

Undergo echocardiography

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGPegylated Liposomal Doxorubicin Hydrochloride

Given IV

DRUGTamoxifen

Given PO


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT06434064


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