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Antineoplastic Agents
Immunotherapy + Chemotherapy for Breast Cancer
Phase 2
Waitlist Available
Led By Harry D. Bear, M.D., Ph.D.
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Locally advanced breast cancer as defined by American Joint Committee on Cancer (AJCC) Staging Criteria
Invasive adenocarcinoma of the breast diagnosed by core needle biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following surgery
Awards & highlights
Study Summary
This trial is testing a new immunotherapy treatment for breast cancer that may be more effective than standard chemotherapy. The treatment consists of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab.
Who is the study for?
This trial is for adults over 18 with locally advanced HER2-negative breast cancer, either hormone receptor-positive or negative. Participants must not be pregnant, agree to contraception, and have proper liver, kidney, and bone marrow function. Exclusions include recent live vaccines, certain heart diseases, immunodeficiencies like HIV, active hepatitis B or C infections, prior treatments for current breast cancer diagnosis or other cancers within the last five years.Check my eligibility
What is being tested?
The study tests if a short course of decitabine followed by pembrolizumab before standard chemo increases immune cells in tumors in patients with advanced HER2-negative breast cancer. It's divided into two groups based on hormone receptor status: one potentially receiving extended pembrolizumab treatment.See study design
What are the potential side effects?
Possible side effects may include allergic reactions to drugs used (decitabine or pembrolizumab), inflammation of organs such as lungs (pneumonitis), fatigue from chemotherapy agents like doxorubicin and paclitaxel; blood disorders due to carboplatin; and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is at an advanced stage but has not spread to distant parts of my body.
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My breast cancer was confirmed with a needle biopsy.
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My breast cancer is HER2-negative according to ASCO/CAP guidelines.
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My breast cancer is either hormone receptor-positive or negative.
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I am fully active or can carry out light work.
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My bone marrow is working well.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months following surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Percentage of Increase in Tumor and Stroma With Infiltrating Lymphocytes (TIL) From Baseline Pre-treatment Biopsy to Post-immunotherapy Biopsy Following Administration of Decitabine Followed by Pembrolizumab.
Secondary outcome measures
Correlation of Intensity of PD-L1 Expression by Assay as it Relates to pCR Rates From Chemotherapy.
Enumeration of T Cells and Immune Cell Subsets
Evaluation of Expression of Protein Programmed Death-Ligand 1 (PD-L1) Within Tumor, Stroma, and Infiltrating Immune Cells Combined, at Baseline and Following Immunotherapy.
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort B: HER2-negative hormone receptor-positive tumorsExperimental Treatment5 Interventions
HER2-negative hormone receptor-positive tumors (Cohort B): Decitabine IV over 60 minutes on 4 days and pembrolizumab IV over 30 minutes on days 8 and 22. Four cycles of dose-dense doxorubicin and cyclophosphamide (AC), followed by 12 doses of weekly paclitaxel.
Group II: Cohort A: Triple Negative Breast Cancer (TNBC)Experimental Treatment6 Interventions
Triple Negative Breast Cancer (Cohort A): Decitabine IV over 60 minutes on 4 days and pembrolizumab IV over 30 minutes on days 8 and 22. Four cycles of dose-dense doxorubicin and cyclophosphamide (AC), followed by 12 doses of weekly paclitaxel and carboplatin.
Group III: Cohort A2: Triple Negative Breast Cancer (TNBC) with Extended PembrolizumabExperimental Treatment6 Interventions
Triple Negative Breast Cancer (Cohort A2). Decitabine IV over 60 minutes on 4 days and pembrolizumab IV over 30 minutes on days 8 and 22. Four cycles of dose-dense doxorubicin and cyclophosphamide (AC), followed by 12 doses of weekly paclitaxel and carboplatin, and pembrolizumab every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3770
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Decitabine
2004
Completed Phase 3
~1680
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
697 Previous Clinical Trials
22,884,950 Total Patients Enrolled
19 Trials studying Breast Cancer
2,444 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,507 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,621 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who is not postmenopausal or without a hysterectomy and have a recent negative pregnancy test.My breast cancer is either hormone receptor-positive or negative.I have been diagnosed with an immunodeficiency, such as HIV.My breast cancer is at an advanced stage but has not spread to distant parts of my body.I have a moderate to severe nervous system disorder.I haven't taken steroids or immunosuppressants in the last 7 days.I have been treated with immunotherapy for my cancer.I have received treatment for my current breast cancer diagnosis before joining this study.I have not received a live vaccine in the last 30 days.I haven't received any monoclonal antibody treatment in the last 4 weeks.My cancer has spread too much for surgery to remove the main tumor.I have had breast cancer or DCIS on the same side before.I have been treated with specific drugs for cancer before.My heart condition allows me to take the study drugs.I have an active tuberculosis infection.I have an active Hepatitis B or C infection.I have not been diagnosed or treated for another cancer within the last 5 years.My breast cancer was confirmed with a needle biopsy.My breast cancer is HER2-negative according to ASCO/CAP guidelines.My bone marrow is working well.I am allergic to decitabine or pembrolizumab.I have had a solid organ or bone marrow transplant.You had a heart test within the last 12 weeks to check how well your heart is pumping.I am currently on medication for an infection.My underarm lymph nodes on the same side as my tumor were checked by MRI or ultrasound within the last 3 months.My kidneys are working well.I am fully active or can carry out light work.I have a history of lung scarring or inflammation not caused by infections.I am 18 years old or older.My liver is working well.I have not needed treatment for an autoimmune disease in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A2: Triple Negative Breast Cancer (TNBC) with Extended Pembrolizumab
- Group 2: Cohort B: HER2-negative hormone receptor-positive tumors
- Group 3: Cohort A: Triple Negative Breast Cancer (TNBC)
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.
What is the current extent of this experiment’s geographical reach?
"At present, the trial is taking place at 5 different locations - Edgewood, Charlottesville and Columbus among others. It would be beneficial for potential participants to choose the closest clinic in order to reduce travel requirements."
Answered by AI
What clinical applications is Paclitaxel commonly used for?
"Commonly prescribed for melanoma, paclitaxel has also been proven to offer therapeutic benefit in the treatment of neoplasm metastasis, malignant melanoma of skin and Kaposi's sarcoma related to HIV."
Answered by AI
What is the approximate size of the population participating in this research?
"This study is not currently recruiting; it was initially published on January 24th 2017, and last updated August 9th 2022. At this time there are 4569 trials searching for participants with receptors of progesterone, as well as 2848 Paclitaxel-related studies actively enrolling patients."
Answered by AI
Has the FDA sanctioned Paclitaxel for therapeutic use?
"The safety of Paclitaxel was assessed as a 2, meaning that while some data exists to support its safety there is still no evidence demonstrating its efficacy."
Answered by AI
Is this research a pioneering endeavor?
"At present, 2848 ongoing studies involving Paclitaxel are occurring across 86 countries and 4438 cities. This drug was first put to the test in a clinical trial twenty-four years ago by Alfacell; this study involved 300 participants and culminated with its Phase 3 approval stage. In total, 3073 trials have been conducted post 1997."
Answered by AI
Does this investigation have any remaining openings for participants?
"According to the information posted on clinicaltrials.gov, this study is not actively recruiting patients at present; though it was last updated on August 9th 2022. Nevertheless, there are 7417 other medical trials that continue to search for participants presently."
Answered by AI
Are there any existing reports of Paclitaxel being utilized for research purposes?
"Paclitaxel was first tested in 1997 at Spectrum Health Hospital - Butterworth Campus. To date, 3073 trials have been closed and 2848 are still recruiting participants; many of these studies can be found in Edgewood, Kentucky."
Answered by AI
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