Phase 1b Study of Pegylated Liposomal Doxorubicin and Pembrolizumab in Endocrine-resistant Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rak piersi, ER dodatni, HER2 ujemny, zaawansowany lokalnie (stopień III) lub z przerzutami (stopień IV)
- •Mierzalne zmiany widoczne w badaniach tomografii lub PET-CT
- •Wiek co najmniej 18 lat
- •Ogólny stan zdrowia oceniony na 0 lub 1 w skali ECOG
- •Przewidywana długość życia co najmniej 3 miesiące
- •Prawidłowe funkcjonowanie narządów wewnętrznych (badania laboratoryjne)
- •Przynajmniej 2 poprzednie leczenia hormonalne, w tym inhibitory aromatazy
- •Przerwa co najmniej 21 dni od ostatniej chemioterapii
✗ Disqualifies
- •Uczulenie na badane leki lub ich składniki
- •Niewydolność serca stopnia IV lub osłabienie funkcji lewej komory serca
- •Zaawansowana choroba płuc (POChP stopnia >3)
- •Marskość wątroby w fazie Class C
- •Zbyt niski poziom albuminy w krwi
- •Zakażenie HIV
- •Aktywne wirusowe zapalenie wątroby typu B lub C
- •Aktywne krwawienia lub zaburzenia krzepnięcia
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 23, 2020
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Shaare Zedek Medical Center
Jerusalem, Israel
Trial contact
Alberto A. Gabizon, MD, PhD
Yair Plesser, MSc
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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