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Anti-metabolites
Azacitidine + Entinostat for Advanced Breast Cancer
Phase 2
Waitlist Available
Led By Vered Stearns
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have histologically or cytologically confirmed adenocarcinoma of the breast triple-negative (ER-, progesterone receptor [PR]-, human epidermal growth factor receptor 2 [HER2]-) or hormone positive/ HER2-, with evidence of locally advanced and inoperable or metastatic disease (American Joint Committee on Cancer [AJCC] Stage IV)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs to treat patients with advanced breast cancer.
Who is the study for?
This trial is for adults with advanced breast cancer that's either triple-negative or hormone-positive/HER2-. They must have tried certain treatments already and be in good enough health to participate. Patients need to provide tissue and blood samples, not be pregnant, use contraception if they can have children, and agree to follow-up visits.Check my eligibility
What is being tested?
The study tests azacitidine combined with entinostat on patients with advanced breast cancer. Azacitidine is a chemotherapy drug that kills or stops tumor cells from dividing. Entinostat blocks enzymes needed for cell growth. The hope is this combination will kill more tumor cells.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, fatigue, nausea, vomiting, low blood counts leading to increased infection risk or bleeding problems. Specific side effects of each drug may vary and should be discussed with the healthcare team.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is advanced, cannot be removed by surgery, and is either triple-negative or hormone positive/HER2-.
Select...
I am fully active or can carry out light work.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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Less than 30% of my liver is affected by cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed Response Rate (Percentage of Participants With Complete or Partial Response Noted as the Objective Status on Two Consecutive Evaluations at Least 4 Weeks Apart) Assessed by RECIST
Secondary outcome measures
Clinical Benefit Rate
Overall Survival
Progression-free Survival (PFS)
Other outcome measures
Circulating DNA Evaluated Using QM-MSP
Confirmed Response Rate to Azacitidine and Entinostat Plus the Addition of Hormone Therapy
Feasibility of the Addition of Hormone Therapy, Evaluated by Calculating the Number of Patients With Disease Progression That go on to Receive Hormonal Therapy
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (entinostat and azacitidine)Experimental Treatment4 Interventions
Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Entinostat
2017
Completed Phase 2
~1170
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,095 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Vered StearnsPrincipal InvestigatorJohns Hopkins University/Sidney Kimmel Cancer Center
3 Previous Clinical Trials
1,163 Total Patients Enrolled
1 Trials studying Breast Cancer
54 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking any other experimental medications.I can have a biopsy taken from my tumor, or I've tried but it was unsuccessful.I don't have any severe illnesses that would affect my participation in the study.My breast cancer is advanced, cannot be removed by surgery, and is either triple-negative or hormone positive/HER2-.I am fully active or can carry out light work.I started hormone therapy less than 3 weeks ago.I have not taken Bevacizumab in the last 6 weeks.I haven't had chemotherapy in the last 3 weeks.I have recovered from side effects of previous treatments, except for hair loss.I am allergic to 5-AZA, entinostat, or mannitol.My kidney function, measured by creatinine levels or clearance, is within the normal range.Your platelet count is at least 100,000 per microliter.I have not had surgery in the last 3 weeks.I am of childbearing age and do not plan to use birth control.Your hemoglobin level should be at least 9.0 grams per deciliter.I have not taken nitrosoureas or mitomycin C in the last 6 weeks.Patients must have a disease that can be measured.Your body has enough white blood cells called neutrophils.You are expected to live for at least 12 more weeks.Your SGOT (AST) level in the blood is not more than three times the normal limit.I haven't taken Trastuzumab in the last 6 weeks.I have not had radiotherapy in the last 3 weeks.I am currently breastfeeding.I have breast cancer that has not responded to at least one prior treatment.I am willing to go back to the hospital where I enrolled for my check-ups.Women who can have babies must have a negative pregnancy test within the last 7 days before joining the study.My hormone-positive cancer is resistant to hormone therapy or I cannot tolerate hormone therapy.Less than 30% of my liver is affected by cancer.Your total bilirubin level should not be higher than 1.5 times the normal limit, unless you have Gilbert's syndrome and it's approved by the Protocol Chair.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (entinostat and azacitidine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for new participants to join the experiment?
"Clinicaltrials.gov suggests that this trial has since ceased its participant recruitment, as evidenced by the initial posting date of April 21st 2011 and last edited on June 28th 2022. Fortunately, there are over 4 thousand other clinical trials actively recruiting patients at present."
Answered by AI
Have pharmacological studies been conducted previously?
"The Pharmacological Study was first undertaken in 2006 by the Chinese University of Hong Kong-Prince of Wales Hospital. To date, 771 trials have been concluded successfully and there are currently 189 ongoing experiments concentrated mainly around Los Angeles, California."
Answered by AI
Are there multiple centers conducting this experiment?
"USC / Norris Comprehensive Cancer Center in Los Angeles, California; University of California Davis Comprehensive Cancer Center in Sacramento, Pennsylvania and Metro Minnesota Community Oncology Research Consortium in Saint Louis Park, Maryland are the main centres running this trial. Additionally there are 7 other sites involved with similar roles."
Answered by AI
How many participants are enrolled in this investigation?
"This particular medical study is no longer accepting enrolments as the last modification was made on June 28th 2022. Fortunately, there are presently 4558 clinical trials for carcinoma and 189 Pharmacological Studies open to patients looking for a trial to join."
Answered by AI
Under what circumstances is a Pharmacological Study commonly prescribed?
"Malignant neoplasms are commonly treated with Pharmacological Study, and this form of therapy may have a positive effect on 20-30% blasts, neutropenia and/or thrombocytopenia, as well as anemia."
Answered by AI
Has the Pharmacological Study earned clearance from the Food and Drug Administration?
"The safety of the Pharmacological Study has been deemed a 2 due to limited evidence supporting its efficacy, despite some data suggesting it is safe."
Answered by AI
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