OncoMatch/Clinical Trials/NCT03591276
Phase 1b Study of Pegylated Liposomal Doxorubicin and Pembrolizumab in Endocrine-resistant Breast Cancer
Is NCT03591276 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Chemotherapy Drugs, Cancer for metastatic breast cancer.
Treatment: Chemotherapy Drugs, Cancer — Very few patients with endocrine-resistant, hormone-receptor positive metastatic breast cancer respond to single agent immunotherapy. Responses to chemotherapy are usually of short duration. Combining immunotherapy with chemotherapy that has minimal immunosuppressive effect, it may be possible to achieve higher response rates while keeping the immune-associated pattern of long durations of response. This will be a single-center phase 1b study to evaluate the tumor response and appropriate dose of a chemo-immunotherapy regime consisting of treatment with pegylated liposomal doxorubicin (PLD) and pembrolizumab-based in endocrine-resistant breast cancer (ERBC) patients. Up to 15 female patients, ages 18 and above, with pathological diagnosis of breast cancer, estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2-) negative subtype, stage III non-operable, or stage IV disease, who have received at least two lines of hormonal therapy, one of which included aromatase inhibitors will be eligible for enrollment to this single arm study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (%ER+ cells≥1%, Allred score ≥3)
ER positive (%ER+ cells≥1%, Allred score ≥3)
Required: HER2 (ERBB2) negative (negative)
Her2 negative subtype
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: hormonal therapy
Have received at least two lines of hormonal therapy, one of which had included aromatase inhibitors.
Cannot have received: anti-PD-1/PD-L1/PD-L2 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Cannot have received: anthracycline (doxorubicin, epirubicin, mitoxantrone, pegylated liposomal doxorubicin)
Anthracycline treatment (doxorubicin, epirubicin, mitoxantrone, PLD) in metastatic setting.
Cannot have received: anthracycline (doxorubicin, epirubicin, mitoxantrone, pegylated liposomal doxorubicin)
Exception: less than 6 months from last treatment
Less than 6 months from last treatment with anthracyclines in adjuvant or neo-adjuvant setting.
Lab requirements
Blood counts
Demonstrate adequate organ function as defined in Table 1
Kidney function
Demonstrate adequate organ function as defined in Table 1
Liver function
Demonstrate adequate organ function as defined in Table 1
Cardiac function
No congestive heart failure (NYHA Class IV) or LVEF ≤40%
Demonstrate adequate organ function as defined in Table 1. Has congestive heart failure (NYHA Class IV) or left ventricular ejection fraction (LVEF) ≤40% [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify