Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Br… (NCT02957968) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
United States46 participantsStarted 2017-01-24
Plain-language summary
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced HER2-negative breast cancer. The primary efficacy objective is to determine if the immunotherapy increases the presence and percentage of tumor and/or stromal area of infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. At enrollment, patients will be assigned to one of 2 cohorts based on hormone receptor status.
* Cohort A - patients with HER2-negative, hormone receptor-negative breast cancer (defined as both ER and PgR with \< 10% positive staining on IHC) Note: before beginning standard neoadjuvant chemotherapy, patients in Cohort A may be reassigned to Cohort A2 to receive extended pembrolizumab as part of new standard neoadjuvant and postoperative adjuvant therapy.
* Cohort B - patients with HER2-negative, hormone receptor-positive breast cancer (defined as either ER or PgR with ≥ 10% positive staining on IHC)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Invasive adenocarcinoma of the breast diagnosed by core needle biopsy
* Breast cancer determined to be HER2-negative per current American Society of Clinical Oncologists/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) Guidelines (If IHC was performed, IHC 0 or 1+; if fluorescence in situ hybridization (FISH) or other in situ hybridization test, dual probe HER2/Chromosome 17 Centromere (CEP17) ratio \< 2.0 with an average HER2 copy number \< 4.0 signals/cell)
* Breast cancer determined to be hormone receptor-positive or hormone receptor-negative defined as follows:
* Hormone receptor-positive: ≥ 10% staining by IHC for either estrogen receptor (ER) or progesterone receptor (PgR)
* Hormone receptor-negative: \< 10% staining by IHC for both ER and PgR
* Locally advanced breast cancer defined as any of the following per American Joint Committee on Cancer (AJCC) Staging Criteria:
* T2 based on tumor measurements by physical examination or imaging and with clinically positive regional lymph nodes (cN1 or cN2), irrespective of hormone receptor status
* Hormone receptor-negative breast cancer patients with tumor size of 3-5 cm measured by physical examination or imaging with clinically negative regional lymph nodes (cN0)
* Any T3 based on tumor measurements by physical examination or imaging
* Any T4 (including inflammatory breast cancer), irrespective of hormone receptor status
* Ipsilateral axillary ly…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is Phase 2 and is no longer enrolling new patients — does that mean results might be available soon, and could those results change the recommended treatment approach for my specific type of HER2-negative breast cancer?
2The trial is measuring whether pembrolizumab and decitabine together increase immune cells called tumor-infiltrating lymphocytes in the tumor before surgery — do my current biopsy results suggest my tumor already has a lot or very few of these immune cells, and does that matter for how I might respond to immunotherapy?
3Since this trial combines an immunotherapy drug with a chemotherapy-sensitizing drug before standard chemo, how does adding those extra treatment steps before standard neoadjuvant chemotherapy compare to just starting standard chemotherapy right away for someone at my stage?
4Pembrolizumab is an immune checkpoint inhibitor that can sometimes cause the immune system to attack healthy organs — given my overall health, are there any specific risks I should be aware of if my doctor were ever considering a similar immunotherapy-based approach for me?
5Since this trial is active but not recruiting, are there any other open trials or recently published results from similar studies that I should be asking about as alternatives to, or alongside, standard neoadjuvant chemotherapy for my stage of HER2-negative breast cancer?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Baseline pre-treatment biopsy to post-immunotherapy biopsy following administration of decitabine followed by pembrolizumab, 3-7 day window after Day 22 medication administration, about one month