OncoMatch/Clinical Trials/NCT06434064
Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer
Is NCT06434064 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pegylated Liposomal Doxorubicin Hydrochloride and Tamoxifen for anatomic stage iii breast cancer ajcc v8.
Treatment: Pegylated Liposomal Doxorubicin Hydrochloride · Tamoxifen — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: TP53 genomic alteration
Patients must have a confirmed eligible TP53 genomic alteration, as determined by the Roswell Park Oncomine™ Precision Assay (OPA) or similar CLIA-approved assay
Required: ESR1 low/negative expression (ER ≤ 10%) (≤ 10%)
tumor staining is ERα low/negative (ER ≤ 10%)
Required: PR (PGR) negative expression (negative)
PgR negative by ASCO/CAP guidelines
Required: HER2 (ERBB2) negative by IHC (0-1+) or IHC 2+ and FISH negative (IHC 0-1+ or IHC 2+ and FISH negative)
HER-2 negative by immunochemistry (IHC) 0-1+ or IHC 2 + and fluorescence in situ hybridization (FISH) negative
Disease stage
Required: Stage III, IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any systemic therapy — metastatic
previously treated with at least 2 lines of therapy in the metastatic setting
Cannot have received: chemotherapy
Exception: must not have received within 4 weeks prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C)
Participants who have had chemotherapy ... within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Cycle 1 Day 1
Cannot have received: hormonal/endocrine therapy
Exception: must not have received within 4 weeks prior to Cycle 1 Day 1
Participants who have had ... hormonal/endocrine therapy ... within 4 weeks prior to Cycle 1 Day 1
Cannot have received: immunotherapy
Exception: must not have received within 4 weeks prior to Cycle 1 Day 1
Participants who have had ... immunotherapy ... within 4 weeks prior to Cycle 1 Day 1
Cannot have received: biologics
Exception: must not have received within 4 weeks prior to Cycle 1 Day 1
Participants who have had ... biologics ... within 4 weeks prior to Cycle 1 Day 1
Cannot have received: radiotherapy
Exception: must not have received within 4 weeks prior to Cycle 1 Day 1
Participants who have had ... radiotherapy ... within 4 weeks prior to Cycle 1 Day 1
Cannot have received: investigational agents/devices
Exception: must not have received within 4 weeks prior to Cycle 1 Day 1
Participants who have had ... any other investigational agents/devices ... within 4 weeks prior to Cycle 1 Day 1
Lab requirements
Blood counts
ANC ≥ 1500/μL; Hemoglobulin (hb) ≥ 9 g/dL; Platelet count ≥ 100,000/μL
Kidney function
Creatinine clearance > 60 mL/min (Cockroft-Gault Equation)
Liver function
Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2 x ULN
Cardiac function
LVEF assessment must be performed within 30 days prior to enrollment; LVEF must be ≥ 50%
ANC ≥ 1500/μL; Hemoglobulin (hb) ≥ 9 g/dL; Platelet count ≥ 100,000/μL; Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2 x ULN; Creatinine clearance > 60 mL/min (Cockroft-Gault Equation); LVEF assessment must be performed within 30 days prior to enrollment. The LVEF must be ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Roswell Park Cancer Institute · Buffalo, New York
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