Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06434064

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

Led by Roswell Park Cancer Institute · Updated on 2026-04-24

30

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with metastatic triple negative breast cancer (ER 64 10%) previously treated with at least 2 lines of therapy in the metastatic setting
  • Confirmed eligible TP53 genomic alteration from tumor sample
  • Tumor ERB1 low/negative (ER 64 10%) and PgR negative by ASCO/CAP guidelines
  • HER-2 negative tumor by IHC 0-1+ or IHC 2+ and FISH negative
  • Age 18 years or older
  • ECOG performance status of 0-1
  • Absolute neutrophil count 64 1500/bcL
  • Hemoglobin 64 9 g/dL
  • Platelet count 64 100,000/bcL
  • Total bilirubin 64 1.5 x upper limit of normal
  • AST and ALT 64 2 x upper limit of normal
  • Creatinine clearance > 60 mL/min
  • Left ventricular ejection fraction 64 50% within 30 days prior to enrollment
  • Ability to swallow oral medications
  • Women of child-bearing potential agree to use effective contraception
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Known contraindications to endocrine therapy
  • Chemotherapy, hormonal/endocrine therapy, immunotherapy, biologics or radiotherapy within 4 weeks prior to cycle 1 day 1 (6 weeks for nitrosoureas or mitomycin C)
  • Not recovered from adverse events related to previous treatments
  • Known hypersensitivity to tamoxifen or its components
  • History or suspicion of hypercoagulable syndrome, thrombosis, stroke, TIA, or pulmonary embolism
  • Known HIV positivity or AIDS-related illness
  • Cardiac disease including angina, arrhythmias (except benign premature ventricular contractions), myocardial infarction history, congestive heart failure, or cardiomyopathy
  • Cirrhosis or severe liver impairment
  • Uncontrolled illness or infection requiring systemic treatment (except uncomplicated UTI)
  • Psychiatric or social conditions limiting study compliance
  • Pregnant or nursing women
  • Unwilling or unable to follow study requirements
  • Any condition deemed unsuitable by the investigator to receive study drug

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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