A Study of Pembrolizumab Alone as Therapy for Metastatic Triple-Negative Breast Cancer

Overview

About this study

The purpose of this study is to examine the effectiveness and safety of pembrolizumab as first line or above treatment in patients with metastatic triple-negative breast cancer. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • For this study neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy
  • For Cohorts A and C
    • At least one systemic treatment for metastatic breast cancer
    • Documented disease progression on the most recent therapy
    • Prior treatment must include an anthracycline and a taxane in the neoadjuvant, adjuvant, or metastatic setting
  • For Cohort B
    • No prior systemic treatment for metastatic breast cancer
    • PD-L1-positive mTNBC
  • For Cohort C
    • PD-L1 strong positive mTNBC
  • For all cohorts
    • mTNBC confirmed by a central laboratory
  • For biomarker analysis
    • adequate newly obtained core or excisional biopsy of a metastatic tumor lesion not previously irradiated
  • Measurable metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
  • Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
  • Adequate organ function

Exclusion Criteria

  • Currently participating in and receiving study therapy
  • Has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to study Day 1
  • Prior anti-cancer monoclonal antibody (mAb) therapy for direct anti-neoplastic treatment within 4 weeks prior to study Day 1
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks prior to study Day 1
  • Not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered within at least 2 weeks prior to study Day 1
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
  • Known additional malignancy that has progressed or required active treatment within the last 5 years
    • Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer
  • Radiographically-detectable central nervous system (CNS) metastases and/or carcinomatous meningitis
  • History of pneumonitis requiring treatment with steroids
  • History of interstitial lung disease
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial medication
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) or has participated in Merck MK-3475 trials
  • Known history of human immunodeficiency virus (HIV)
  • Known active Hepatitis B or C
  • Received a live vaccine within 30 days of planned start of study medication

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Alvaro Moreno Aspitia, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Donald Northfelt, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions