Overview

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

Status:
Not yet recruiting
Trial end date:
0000-00-00
Target enrollment:
37
Participant gender:
Both
Summary
The goal of this clinical research study is to learn if pembrolizumab in combination with standard hormone therapy can help to control and prevent inflammatory breast cancer (IBC). The safety of this drug combination will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Pembrolizumab
Last Updated:
2016-11-22
Criteria
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
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 patient has been on hormonal blockade
therapy within 2 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 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. 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.