Tamoxifen and Pegylated Liposomal Doxorubicin for Metastatic Triple-Negative Breast Cancer
This study is testing the combination of tamoxifen and pegylated liposomal doxorubicin for patients with triple-negative breast cancer that has spread (metastatic) or is locally advanced and cannot be removed by surgery. Tamoxifen works by blocking estrogen, which can slow tumor growth, while doxorubicin damages cancer cell DNA. The study aims to see how well this combination shrinks tumors. You may be able to join if you have metastatic triple-negative breast cancer, have already received at least two other treatments for it, and have a specific change in your TP53 gene. The main goal is to measure how many patients experience tumor shrinkage, with results tracked for up to four years. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 30 participants. It is not specified if it is a single-arm or randomized study, or its phase.
- What's involved
- You would undergo procedures such as tumor biopsies, blood sample collections, CT scans, echocardiograms, and MRIs.
- Compensation
- Not stated in the trial record.
- Follow-up
- The overall response rate, a measure of tumor shrinkage, will be tracked for up to four years.
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NCT06434064
Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentRoswell Park Cancer InstituteInvestigator-initiated
~30 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyEchocardiographyMagnetic Resonance ImagingPegylated Liposomal Doxorubicin Hydrochloride
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate
Measured over Up to 4 years
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Sheheryar Kabraji · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Overall response rateUp to 4 years
Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be summarized using frequencies and relative frequencies.