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 range18 Years
SexALL
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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.
✓. Has positive ER or PR status. ER or PR \>/= 10%
✓. 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.
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 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.