Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast … (NCT02971748) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy
United States36 participantsStarted 2017-01-26
Plain-language summary
This phase II trial studies how well pembrolizumab works in treating patients with hormone receptor positive inflammatory breast cancer that has not spread to other parts of the body, who are receiving hormone therapy and did not achieve a pathological complete response to chemotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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
. Is willing and able to provide written informed consent for the trial.
. Is a female or male and \>/= 18 years of age
. Has histological confirmation of breast carcinoma.
. Has confirmed inflammatory breast cancer by using international consensus criteria:
. Did not achieve pathological complete response (pCR) to any chemotherapy that was given with the intention to induce best response prior surgery. pCR is defined as the current American Joint Committee on Cancer (AJCC) breast cancer staging.
. Is HER2 normal, defined as HER2 0 or 1+ by IHC and negative by FISH if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performed.
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.
1Since this is a Phase 2 trial, what does that mean for how much is already known about whether pembrolizumab is safe and effective specifically for hormone receptor-positive inflammatory breast cancer patients like me who didn't have a full response to chemotherapy?
2This trial is no longer enrolling new patients — does that mean I've missed my chance to participate, or are there similar trials or expanded access options you'd recommend I look into instead?
3Given that my cancer didn't achieve a pathological complete response to chemotherapy, how does adding pembrolizumab to hormone therapy compare to continuing hormone therapy alone as a next step in my care?
4The trial is measuring disease-free survival and treatment-related side effects — what kinds of immune-related side effects has pembrolizumab caused in breast cancer patients, and how might those interact with the hormone therapy I'm already on?
5Inflammatory breast cancer is already an aggressive diagnosis at Stage IIIB or IIIC — in your view, would participating in or following the results of this trial change the treatment path you'd recommend for me right now?
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
Disease Free Survival (DFS)
Timeframe: From treatment initiation through last available follow-up (up to approximately 9 years)
2
Participants With Treatment-Related Adverse Events
Timeframe: From first dose through 30 days after last dose (up to approximately 25 months)
. Has a performance status of 0-1 on the ECOG Performance Scale.
Exclusion criteria
. Is currently participating in a study of an investigational anti-cancer agent.
. Has a diagnosis of immunodeficiency or any other form of immunosuppressive therapy.
. Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery.
. Has a known history of prior malignancy with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy and has no evidence of recurrence over the last 1 year since completion of curative therapy.
. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or immunosuppressive agents. Participants with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Participants that require intermittent use of bronchodilators, inhaled steroid or local steroid injections to the skin would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study.
. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
. Has an active infection requiring systemic therapy.
. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.