Study on Tamoxifen and Pegylated Liposomal Doxorubicin for Treating Advanced Triple Negative Breast Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT06434064

Provider View

This clinical trial is exploring the effectiveness of combining tamoxifen and pegylated liposomal doxorubicin to treat patients with advanced triple negative breast cancer that cannot be surgically removed or has spread to other parts of the body.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, tamoxifen and pegylated liposomal doxorubicin, to see how well they work together in treating patients with triple negative breast cancer that has spread or cannot be operated on. Tamoxifen blocks estrogen, which may help stop the growth of cancer cells that need estrogen. Pegylated liposomal doxorubicin is a form of chemotherapy that targets cancer cells and may have fewer side effects than other forms. The study aims to find out if using these drugs together is more effective than using them separately.

Description

The main goal of this study is to see how effective the combination of tamoxifen and pegylated liposomal doxorubicin is in treating patients with advanced triple negative breast cancer. Researchers will measure how well the cancer responds to the treatment using specific criteria.

Secondary goals include assessing the safety of the treatment and how well patients tolerate it. The study will also look at how long patients live without the cancer getting worse and how long the treatment's effects last.

Researchers will explore additional aspects, such as changes in cancer-related DNA in the blood, interactions between certain proteins in the tumors, and changes in gene activity. They will also study the tumor environment and immune cell changes in response to the treatment.

Participants will take tamoxifen by mouth daily and receive pegylated liposomal doxorubicin through an IV every 28 days. The treatment will continue as long as it is effective and does not cause unacceptable side effects. Throughout the study, participants will have heart tests, scans, biopsies, and blood tests.

After finishing the treatment, participants will have follow-up visits 30 days later and every six months for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed metastatic triple negative breast cancer that has been treated with at least two previous therapies.
  • Tumor must be low or negative for estrogen and progesterone receptors and HER-2 negative.
  • Be 18 years or older.
  • Have a performance status indicating full activity or some restriction in strenuous activities.
  • Have adequate blood cell counts and organ function based on specific tests.
  • Have a heart function test showing at least 50% pumping ability.
  • Be able to swallow pills.
  • Agree to use effective birth control methods if of childbearing potential.
  • Understand the study and sign a consent form.

Exclusion Criteria

  • Have any known reasons that prevent the use of hormone therapy.
  • Have received certain treatments within the last 4-6 weeks or have not recovered from previous treatment side effects.
  • Have allergies to tamoxifen or similar drugs.
  • Have a history of blood clotting disorders or certain cardiovascular conditions.
  • Have HIV or AIDS-related illness.
  • Have severe liver disease or cirrhosis.
  • Have active infections or psychiatric conditions that would interfere with the study.
  • Be pregnant or breastfeeding.
  • Be unwilling or unable to follow study requirements.
  • Have any condition that makes participation unsuitable according to the investigator.

Locations

FACILITYZIPCITYSTATE
Roswell Park Cancer Institute14263BuffaloNew York

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