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Trial record 5 of 60 for:    PD-1 and breast cancer | Recruiting, Not yet recruiting, Available Studies

A Study of Anti-PD-1 (Pembrolizumab) + Hormonal Therapy in HR-positive Localized IBC Patients With Non-pCR to Neoadjuvant Chemotherapy

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: NCT02971748
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : March 22, 2019
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) that did not respond completely to chemotherapy.

The goal of this clinical research study is to learn if pembrolizumab in combination with standard hormone therapy can help to control and prevent IBC. The safety of this drug combination 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 IBC in combination with standard hormonal therapy is considered investigational.

The study doctor can explain how the study drugs are designed to work.

Up to 37 participants will be enrolled in this study. All will take part at MD Anderson.

Condition or disease Intervention/treatment Phase
Inflammatory Breast Cancer Malignant Neoplasm of Breast Drug: Pembrolizumab Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Anti-PD-1 (Pembrolizumab) in Combination With Hormonal Therapy in Patients With Hormone Receptor (HR)-Positive Localized Inflammatory Breast Cancer (IBC) Who Did Not Achieve a Pathological Complete Response (pCR) to Neoadjuvant Chemotherapy
Actual Study Start Date : January 26, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab
200 mg on day 1 of each 3-week cycle as 30 minute intravenous (IV) infusion
Drug: Pembrolizumab
Pembrolizumab 200 mg administered on day 1 of each 3-week cycle as approximately 30 minute IV infusion. Hormonal therapy at physicians' discretion including tamoxifen, exemestane, anastrozole, letrozole, LHRH agonist and combination with any of above and starts at the same time as pembrolizumab.
Other Names:
  • Keytruda
  • MK-3475
  • SCH-900475

Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: Up to 24 months ]
    Disease-free survival (DFS) as evidenced by the participant remaining alive with continued disease control. Disease progression status follow up: 24 months after the first treatment of the study regimen for participants who were taken off study treatment for reasons other than disease progression.

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.

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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. Has histological confirmation of breast carcinoma.
  4. Has confirmed inflammatory breast cancer by using international consensus criteria: (1) Onset: Rapid onset of breast erythema, edema and/or peau d'orange, and/or warm breast, with/without an underlying breast mass. (2) Duration: History of such findings no more than 6 months (3) Extent: Erythema occupying at least 1/3 of whole breast. (4) Pathology: Pathologic confirmation of invasive carcinoma
  5. 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
  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 positive ER or PR status. ER or PR >/= 10%
  8. Has a performance status of 0-1 on the ECOG Performance Scale.
  9. 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
  10. Subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and for 120 days after the last dose of study drug by complying with one of the following: (1) practice abstinence† from heterosexual activity; OR (2) use (or have their partner use) acceptable contraception during heterosexual activity.
  11. Has negative serum or urine pregnancy test for subjects of childbearing potential within 10 days before first dose.
  12. If patient has already started hormonal blockade therapy after radiation as adjuvant therapy, patient is eligible as long as the hormonal therapy was initiated no more than 6 months by the time of screening and can start the study drug within 4 weeks since the completion of screening

Exclusion Criteria:

  1. Is currently participating in a study of an investigational anti-cancer agent.
  2. Has a diagnosis of immunodeficiency 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 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
  5. 5. 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. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators, inhaled steroid or local steroid injections to the skin would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study.
  6. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  7. Has an active infection requiring systemic therapy.
  8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  9. 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).
  10. Has a known history of Human Immunodeficiency Virus (HIV).
  11. Has a known active Hepatitis B or Hepatitis C
  12. Have received a live vaccine within 30 days prior to the first dose of trial treatment.
  13. Gastrointestinal tract disease or defect or previous history of colitis
  14. Distant metastasis that involves occurrence of breast cancer outside of locoregional breast and lymph nodes area
  15. Subjects requiring daily corticosteroids either via po or infusion
  16. Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication.

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): NCT02971748

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Contact: Bora Lim, MD 713-792-2817

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United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: MD Anderson Health Information Specialist    877-632-6789      
Contact: Breast Medical Oncology    713-792-2817      
Sponsors and Collaborators
M.D. Anderson Cancer Center
Merck Sharp & Dohme Corp.
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Study Chair: Bora Lim, MD The University of Texas MD Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT02971748     History of Changes
Other Study ID Numbers: 2016-0096
NCI-2018-01297 ( Registry Identifier: NCI CTRP )
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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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:
hormone receptor-positive localized inflammatory breast cancer
Hormonal therapy
standard adjuvant hormonal therapy
maintenance therapy
immune related biomarkers
PD-L1 expression
HR positive
HR-positive localized IBC

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