RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: Biopsies, Blood draws, MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To analyze changes in circulating tumor deoxyribonucleic acid (ctDNA) from longitudinal liquid biopsy to follow therapeutic response."
  • "Patients undergo echocardiography, computed tomography (CT) scan or magnetic resonance imaging (MRI), tumor biopsy and blood sample collection throughout the study."
  • "After completion of study treatment, patients are followed up at 30 days and every 6 months for up to 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests tamoxifen with pegylated liposomal doxorubicin, a cancer drug wrapped in tiny fat-like particles. It is for people with triple negative breast cancer that has spread to other parts of the body or nearby areas and cannot be removed by surgery. The study asks how well these drugs work together.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have triple negative breast cancer confirmed by testing that has spread to other parts of the body. Have had at least 2 types of treatment for cancer at this stage.
  • Have a qualifying change in the TP53 gene, confirmed by an approved test on a stored tumor sample or a new biopsy.
  • Tumor tests must show low or no estrogen receptors (ER 10% or less), no progesterone receptors, and negative HER2 status. These are proteins that can help cancer grow.
  • Be fully active or able to do light work, with limits only on heavy activity.
  • Meet the study's blood count, liver, and kidney test requirements. A heart test within 30 days before joining must show a pumping strength of at least 50%.
  • Be able to swallow pills. If able to become pregnant, agree to use birth control before joining and tell the doctor right away about any possible pregnancy.
  • Understand the study and sign a consent form before any study procedures.

Who can't join

  • Have a medical reason hormone treatment would be unsafe, or a past allergic reaction to tamoxifen ingredients or similar drugs.
  • Have had cancer treatment or an experimental drug or device within 4 weeks before starting (6 weeks for nitrosoureas or mitomycin C), or have not recovered from earlier treatment side effects.
  • Have a known or suspected condition that makes blood clot too easily, or a history of blood clots, stroke, mini-stroke, or a clot in the lungs.
  • Have known HIV infection or an AIDS-related illness.
  • Have heart disease that makes the study drugs unsafe, such as certain abnormal heart rhythms, heart-related chest pain, a past heart attack, heart failure, or heart muscle disease.
  • Have severe liver damage or cirrhosis, which is scarring of the liver.
  • Have an uncontrolled illness, an infection needing treatment throughout the body (except a simple urinary tract infection), or another condition the study doctor believes makes treatment unsuitable.
  • Be pregnant or breastfeeding, or be unwilling or unable to follow study requirements, including because of mental health or social problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients with pathologically confirmed metastatic triple negative breast cancer (ER ≤ 10%) that have been previously treated with at least 2 lines of therapy in the metastatic setting * Patients must have a confirmed eligible TP53 genomic alteration, as determined by the Roswell Park Oncomine™ Precision Assay (OPA) or similar CLIA-approved assay, using either an archival metastatic tumor sample or, if unavailable, a fresh biopsy. Uncertainty about the eligibility of the TP53 genomic alteration for this study can be resolved by discussion with the study PI * Patients must have ERα (estrogen receptor alpha) and PgR (progesterone receptor) status assessed using current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Patients are eligible if the tumor staining is ERα low/negative (ER ≤ 10%) and PgR negative by ASCO/CAP guidelines * The tumor must be HER-2 negative by immunochemistry (IHC) 0-1+ or IHC 2 + and fluorescence in situ hybridization (FISH) negative * Patients must be ≥ 18 years of age * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Absolute neutrophil count (ANC) ≥ 1500/ μL * Hemoglobulin (hb) ≥ 9 g/dL * Platelet count ≥ 100,000/ μL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x ULN * Creatinine clearance \> 60 mL/min (Cockroft-Gault Equation) * Left ventricular ejection fraction (LVEF) assessment must be performed within 30 days prior to enrollment. (LVEF assessment performed by 2-D echocardiogram is preferred; however, multigated acquisition scan \[MUGA\] scan may be substituted based on institutional preferences). The LVEF must be ≥ 50% regardless of the cardiac imaging facility's lower limit of normal * Patients must be able to swallow oral medications * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients must not have any known contraindications to endocrine therapy, in the opinion of the treating investigator * Participants who have had chemotherapy, hormonal/endocrine therapy, immunotherapy, biologics or radiotherapy (as well as any other investigational agents/devices) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C), or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Have a known history of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to tamoxifen or any of its excipients * Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, transient ischemic attack (TIA), or pulmonary embolism * Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness * Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimen. This includes angina pectoris, arrhythmias except for benign premature ventricular contractions, a history of myocardial infarction, documented congestive heart failure (CHF) or cardiomyopathy * Patients with cirrhosis or severe hepatic impairment * Patients must not have a condition or an uncontrolled intercurrent illness including, but not limited to any of the following: ongoing or active infection requiring systemic treatment, except uncomplicated urinary tract infection (UTI), or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug

Study sites (1)

NY