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

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Locally Advanced Unresectable Triple-Negative Breast Carcinoma
• Metastatic Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy — PROCEDURE
  Undergo tumor biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Echocardiography — PROCEDURE
  Undergo echocardiography
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
  Given IV
• Tamoxifen — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Mar 3, 2026

Status verified

Apr 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (tamoxifen, pegylated liposomal doxorubicin)
  Patients receive tamoxifen PO QD on days 1-28 of each cycle and pegylated liposomal doxorubicin IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography, CT scan or MRI, tumor biopsy, and blood sample collection throughout the study.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 4 years ]

Locations (1)

Find similar trials in Buffalo, NY

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