A Study of Experimental Pembrolizumab (MK-3475) in Combination With Chemotherapy & Endocrine Therapy for Breast Cancer

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: cancer, breast cancer, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2–) Breast Cancer, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer, ER+/HER2– Breast Cancer
Type: Biological study, Phase 3
Target:
5 Participants
Investigator:
Description
The purpose of this study is to:
o Test the safety of the study drug, pembrolizumab (MK-3475), with certain types of chemotherapy and endocrine therapy.
o See how well the study drug, pembrolizumab, works when combined with chemotherapy and endocrine therapy.
o To see if combining the study drug with chemotherapy will have a positive outcome on your surgery, compared to these treatments alone.
o To see if combining the study drug with chemotherapy and endocrine therapy keeps your cancer from returning sooner.
o To see if combining the study drug with chemotherapy and endocrine therapy helps you live longer.
o See how your body handles the study drug.

This is a study to test Pembrolizumab for your type of breast cancer. It has not been approved by the FDA to treat breast cancer, but it is approved to treat other types of cancer.

The chemotherapies being used in this study (Paclitaxel, Doxorubicin, Epirubicin and Cyclophosphamide) are approved. They are widely used, as a treatment for your type of breast cancer.

Endocrine therapy is also approved to treat your type of breast cancer. You will receive endocrine therapy as part of your treatment during the study.

The use of these drugs together with pembrolizumab is experimental. “Experimental” means that the study drug is currently being tested. It is not approved by the U.S. FDA
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is allowed.
  • Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.
  • Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, grade, and PD-L1 status.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to initiation of study treatment.
  • Male participants must agree to use contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period.
  • Female participants must agree to use effective contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment with pembrolizumab or placebo.
  • Has adequate organ function.

Exclusion criteria:

  • Has a history of non-infectious pneumonitis that required treatment with steroids or has current pneumonitis.
  • Has breast cancer with lobular histology.
  • Has bilateral invasive breast cancer.
  • Has metastatic (Stage IV) breast cancer.
  • Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast).
  • Has any of the following clinical lymph node staging per current American Joint Committee on Cancer (AJCC) staging criteria for breast cancer staging based on radiological and/or clinical assessment: cN3, cN3a, cN3b, or cN3c.
  • Has ER-, progesterone receptor positive breast cancer.
  • Has undergone excisional biopsy of the primary tumor and/or axillary lymph nodes or has undergone sentinel lymph node biopsy prior to study treatment.
  • Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal breast carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Has a known history of active tuberculosis (Bacillus tuberculosis).
  • Has an active infection requiring systemic therapy.
  • Has left ventricular ejection fraction (LVEF) of <50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.
  • Has other significant cardiac disease, such as: 1) History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the last 6 months; or 2) Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of hepatitis B or known active hepatitis C virus infection.
  • Has received prior treatment for breast cancer.
  • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137).
  • Has received a live vaccine within 30 days prior to the first dose of study treatment.
  • Has severe hypersensitivity (≥Grade 3) to any of the components or excipients used in the study treatments.
  • Is/was enrolled in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks (12 months for an investigational agent or device with anticancer or antiproliferative properties) prior to the first dose of study treatment.
  • Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will be in the study about 12 years.
Recruitment period
From April 29, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Breast Cancer