Clinical Trials /

Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy

NCT02971748

Description:

This phase II trial studies how well pembrolizumab works in treating patients with hormone receptor positive inflammatory breast cancer that has not spread to other parts of the body, who are receiving hormone therapy and did not achieve a pathological complete response to chemotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 2016-0096
  • NCT ID: NCT02971748

Conditions

  • Inflammatory Breast Cancer
  • Malignant Neoplasm of Breast

Interventions

DrugSynonymsArms
PembrolizumabKeytruda, MK-3475, SCH-900475Pembrolizumab

Purpose

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.

Detailed Description

Study Drug Administration:

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

They will also receive hormonal therapy that their doctor has chosen for their standard treatment. The study doctor will tell them which hormonal therapy they receive, its risks, and how often they will receive it.

Length of Study:

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

Their participation on the study will be over after the follow-up visits (described below).

Study Visits

On Day 1 of each cycle:

- They will have a physical exam

- Blood (about 2 tablespoons) will be drawn for routine tests.

At Cycle 4 and then every 3 cycles after that (before Cycle 4, 7, 10, 13 and so on), they will have imaging scans, including an EKG and either an ECHO or MUGA scan, to check the status of the disease as part of their standard care. Also, blood (about 7 tablespoons) will be drawn for biomarker and immune system testing. This blood will also be drawn if the disease appears to get worse.

End-of-Treatment Visit:

As soon as possible after they stop receiving the study drugs:

- They will have a physical exam.

- Blood (about 10 tablespoons) will be drawn for routine, biomarker, and immune system testing.

- They will have the same imaging scans they had at screening to check the status of the disease.

- If the doctor thinks it is needed, they will have an EKG and either an ECHO or MUGA scan.

Follow-Up:

About 1 month after the last dose of study drugs, they will be asked about their health and any side effects they may have had. They may be asked during a routine clinic visit or they may be called. If they are called, each call should last about 2 minutes.

If they stopped taking the study drugs for reasons other than the disease getting worse, they will be called about 24 months after their first dose of pembrolizumab to learn how they are doing. If they are called, this should last about 3 minutes.

Trial Arms

NameTypeDescriptionInterventions
PembrolizumabExperimental200 mg on day 1 of each 3-week cycle as 30 minute intravenous (IV) infusion
  • Pembrolizumab

Eligibility 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 </= 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 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.

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease-free survival (DFS)
Time Frame:Up to 24 months
Safety Issue:
Description: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.

Secondary Outcome Measures

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

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

Last Updated

November 22, 2016