MK-3475 for Metastatic Inflammatory Breast Cancer (MIBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02411656
Recruitment Status : Recruiting
First Posted : April 8, 2015
Last Update Posted : December 25, 2018
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

You are being asked to take part in this study because you have inflammatory breast cancer (IBC) or triple negative breast cancer (TNBC) that is metastatic (has spread to other parts of the body).

The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475 and Keytruda) can help to control metastatic IBC and TNBC. The safety of this drug will also be studied.

This is an investigational study. Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma. Its use in patients with metastatic IBC and TNBC is investigational. The study doctor can describe how the study drug is designed to work.

Up to 35 participants will be enrolled in this study. All will take part in at MD Anderson.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: MK-3475 Behavioral: Follow Up/Phone Call Phase 2

Detailed Description:

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive pembrolizumab by vein over about 30 minutes on Day 1 (+/- 3 days) of each 21-day cycle.

Study Visits:

On Day 1 of each cycle:

  • You will have a physical exam.
  • Blood (about 2-3 tablespoons) will be drawn for routine tests.

At Cycles 3, every 3rd cycle after that (Cycles 6, 9, 12, and so on), and if the disease gets worse, blood (about 10 tablespoons) will be drawn for biomarker and immune system testing.

About every 2 Cycles, you will have imaging scans to check the status of the disease as part of standard of care. .

Length of Study:

You may continue taking the study drug for up to 24 months, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

End-of-Treatment Visit:

After you stop receiving the study drug:

  • You will have a physical exam.
  • Blood (about 10 tablespoons) will be drawn for routine tests.
  • You will have the same imaging scans you had at screening to check the status of the disease.


About 1 and 3 months after the last dose of study drug, you will be asked about your health and any side effects you may have had. You may be asked during a routine clinic visit or you may be called. If you are called, each call should last about 2 minutes.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer (IBC) or Non-IBC Triple Negative Breast Cancer (TNBC) Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: MK-3475

MK-3475 200 mg administered on Day 1 of each 21 day cycle as a 30 minute infusion by vein for up up to 24 months.

Follow up or phone call about 1-3 months after last dose of study drug.

Drug: MK-3475
200 mg administered on Day 1 of each 21 day cycle as a 30 minute infusion by vein.
Other Names:
  • Keytruda
  • Pembrolizumab
  • SCH-900475

Behavioral: Follow Up/Phone Call
About 1 and 3 months after last dose of study drug, participant to have follow up or phone call. If participant is called, each call should last about 2 minutes.

Primary Outcome Measures :
  1. Disease Control Rate [ Time Frame: 4 months ]
    Disease control rate defined as the percentage of patients either 1) with measurable disease that maintain complete response (CR) or partial response (PR), or upgrade from PR to CR, or 2) with non-measurable disease that remain CR or stable disease (SD), or upgrade from SD to CR, by 4 months or more in all evaluable patients.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Is willing and able to provide written informed consent for the trial.
  2. Is a female or male and >/= 18 years of age
  3. A).Has histological confirmation of HER2 normal breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast. Pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis of inflammatory breast cancer regardless ER/PR status; OR B).Has histological confirmation of triple negative breast carcinoma (HER2 normal, ER/PR < 10%) without clinical diagnosis of IBC
  4. Has stage IV or recurrent disease that has been treated
  5. Has clinical response or stable disease for minimum of two months (three cycle of every three week chemotherapy or 8 weeks of weekly regimen, etc.) after receiving any prior chemotherapy for metastatic/recurrent disease. A minimum of two cycles (6-8 weeks) of chemotherapy is required to determine clinical response. Per RECIST criteria 1.1, Clinical response for measurable disease is defined as complete response (CR) or partial response (PR); for non-measurable disease only (i.e. bone metastasis, ascites, pleural effusion, and pathological lymph nodes >/= 10 to <15 mm short axis) is defined as persistence of one or more non-target lesion(s) and no increase in overall tumor burden.
  6. 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.
  7. Has a performance status of 0-1 on the ECOG Performance Scale.
  8. Has adequate organ function as determined by the following laboratory values: ANC >/= 1,500 /mcL, Platelets >/=100,000 /mcL, Hgb >/= 9 g/dL, creatinine levels < 1.5 x ULN, Total bilirubin </= 1.5 x ULN, ALT and AST </= 2.5 x ULN or </=5 x ULN for subjects with liver metastases.
  9. Subjects of childbearing potential should be willing to use effective methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of study drug.Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Effective methods of birth control include 1). Use of hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin); 2).Intrauterine devices (IUDs); 3).Using 2 barrier methods (each partner must use 1 barrier method) with a spermicide. Males must use the male condom (latex or other synthetic material) with spermicide. Females must choose either a Diaphragm with spermicide, or Cervical cap with spermicide, or a sponge (spermicide is already in the contraceptive sponge).
  10. Has negative serum or urine pregnancy test for subjects of childbearing potential.

Exclusion Criteria:

  1. Is currently participating in a study of an investigational anti-cancer agent.
  2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy.
  3. Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery.( Note: Subjects with ≤ Grade 2 neuropathy, alopecia and general disorders and administration site conditions (per CTCAE version 4.0) are an exception to this criterion and may qualify for the study.)
  4. Has a known malignancy (other than breast cancer) except basal cell carcinoma or squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate if they are stable, and have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
  6. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
  7. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  8. Has an active infection requiring systemic therapy.
  9. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  10. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) within 3 months.
  11. Has a known history of Human Immunodeficiency Virus (HIV).
  12. Has a known active Hepatitis B or Hepatitis C
  13. Have received a live vaccine within 30 days prior to the first dose of trial treatment.
  14. Is receiving concurrent anti-cancer therapy for metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02411656

Contact: Naoto Ueno, MD, PHD 713-792-2817

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Merck Sharp & Dohme Corp.
Principal Investigator: Naoto Ueno, MD, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT02411656     History of Changes
Other Study ID Numbers: 2014-0533
NCI-2015-00671 ( Registry Identifier: NCI CTRP )
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Breast cancer
Metastatic inflammatory breast cancer
Breast carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents