Actively Recruiting
Phase 1b Study of Pegylated Liposomal Doxorubicin and Pembrolizumab in Endocrine-resistant Breast Cancer
Led by Shaare Zedek Medical Center · Updated on 2020-10-23
15
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1b Study of Pegylated Liposomal Doxorubicin and Pembrolizumab in Endocrine-resistant Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Pathological diagnosis of breast cancer, estrogen receptor positive and HER2 negative subtype
- Locally advanced (stage III non-operable) or metastatic (stage IV) disease
- Measurable disease on CT or PET-CT scans
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Estimated life expectancy of at least 3 months
- Adequate organ function based on laboratory tests within 10 days prior to treatment
- Received at least two lines of hormonal therapy, including aromatase inhibitors
- May have received up to 2 lines of chemotherapy excluding adjuvant or neoadjuvant treatment
- At least 21 days treatment-free interval since last chemotherapy
- Negative pregnancy test within 72 hours prior to first dose if of childbearing potential
- Willing to use contraception during the study and for 120 days after last dose if of childbearing potential
- Able to understand and willing to comply with study procedures and provide informed consent
You will not qualify if you...
- Known allergy to study drugs or their ingredients
- Congestive heart failure (NYHA Class IV) or left ventricular ejection fraction below 40%
- Chronic obstructive pulmonary disease worse than Stage 3
- Liver cirrhosis classified as Child-Pugh Class C
- Low serum albumin level below 2.5 g/dl
- HIV infection
- Active Hepatitis B or C infection
- Active bleeding or bleeding disorders
- Use of other chemotherapy or hormonal therapy during the study except study drugs
- Uncontrolled ascites requiring frequent drainage
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Continuous corticosteroid treatment above 10 mg prednisone daily except for brain metastases
- Prior anthracycline treatment in metastatic setting or within 6 months in adjuvant/neoadjuvant setting
- Use of investigational drugs within 28 days before study entry
- Recent or active other malignancies requiring treatment within 5 years
- Severe gastrointestinal conditions or uncontrolled diarrhea
- Participation in another investigational study within 4 weeks
- Immunodeficiency or immunosuppressive therapy within 7 days before treatment
- Active tuberculosis infection
- Recent monoclonal antibody or chemotherapy treatment with unresolved side effects
- Additional progressing malignancy requiring treatment
- Active or unstable brain metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active non-infectious pneumonitis
- Serious active infections requiring systemic therapy
- Medical or psychiatric conditions interfering with study participation
- Pregnant, breastfeeding, or planning pregnancy during study and 120 days after
- Live vaccines within 30 days before study start (except inactivated flu vaccines)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Actively Recruiting
Research Team
A
Alberto A. Gabizon, MD, PhD
CONTACT
Y
Yair Plesser, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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