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A Phase II Trial Of The JAK-Inhibitor Ruxolitinib (INCB018424) In Combination With Exemestane For Patients With Estrogen Receptor (ER) Positive Advanced Breast Cancer)

Phase 2
18 Years
Open (Enrolling)
Estrogen-receptor Positive Invasive Metastatic Breast Cancer

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Trial Information

A Phase II Trial Of The JAK-Inhibitor Ruxolitinib (INCB018424) In Combination With Exemestane For Patients With Estrogen Receptor (ER) Positive Advanced Breast Cancer)

Abstract Brief abstract (250 words or less) describing the study in language understandable
to a lay person. Include brief description of the purpose, target disease/condition if
applicable, key eligibility criteria, and main study interventions This is a Phase II
investigator-Initiated trial of the Investigational Drug, Ruxolitinib, in combination with
Exemestane in patients with estrogen-receptor positive advanced breast cancer. The objective
of this study is to determine the preliminary safety and efficacy of the combination of
exemestane and Ruxolitinib (INCB018424). A maximum of 25 people will be enrolled on this
study at the University of Pennsylvania.

As part of this study, subjects have the option of providing separate consent for research
related biopsies (at baseline and Cycle 1/Day 22). If they provide consent, subjects will be
co-enrolled on a separate sample acquisition research study under the direction of Dr.
Angela DeMichele (IRB #811841/UPCC#17110: Collection of Tumor Tissue, Blood and Clinical
Data from Patients with Advanced Breast Cancer (short name TRACR-MET)) through which these
biopsies will be performed with Radiology support. The study team will review this separate
consent with the study subjects considering participation in this optional component so that
they can make a fully educated decision regarding whether or not they would like to

Inclusion Criteria:

- Histologically-confirmed, invasive metastatic breast cancer.

- Estrogen-receptor positivity (defined by at least 5% staining by
immunohistochemistry) on either the primary breast tumor or a metastatic biopsy.

- Postmenopausal status, defined as: either surgical menopause via oophorectomy, or
natural menopause in which the patient has had no menses in the previous 12-month
period. Premenopausal patients who have been been rendered amenorrheic by tamoxifen
must have a serum estradiol level 30 pg/ml after discontinuation of tamoxifen.
Amenorrheic premenopausal subjects must have a negative pregnancy test during
screening (prior to enrollment) and must be advised to use adequate contraception
throughout their participation.

- Prior therapy for the current malignancy: Patient must have 1) relapsed within 2
years of completing adjuvant hormonal therapy with a non-steroidal aromatase
inhibitor, OR 2) failed a non-steroidal aromatase inhibitor in the metastatic
setting. There is no limit to prior chemotherapy or hormonal regimens for this

- Patient must have one measurable lesion by RECIST criteria. Bone-only disease is not

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Adequate organ and bone marrow function

- The subject is capable of understanding and complying with the protocol requirements
and has signed the informed consent document.

Exclusion Criteria:

- Chemotherapy, hormonal therapy or investigational anti-tumor therapy within 21 days
of starting study treatment. Use of bone-building agents is allowed.

- Any type of investigational agent within 28 days before the first dose of study

- Unresolved clinically-meaningful toxicity due to prior therapy. Toxicity from
previous treatment must be back to baseline or Grade 1, with the exception of
neurotoxicity and alopecia.

- Untreated or uncontrolled brain metastases or evidence of leptomeningeal involvement
of disease. Patients who have stable disease after radiotherapy for CNS disease are
eligible. Testing for brain involvement in the absence of symptoms is not required as
part of this protocol.

- Uncontrolled, intercurrent illness including, but not limited to:

- Known ongoing or active infection, including active hepatitis B or hepatitis C.
Testing for hepatitis B or C is not required as part of this protocol.

- Uncontrolled diabetes mellitus

- Uncontrolled hypertension

- Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial
infarction within 3 months

- A baseline corrected QT interval (QTc) greater than 470 ms.

- The subject is known to be positive for the human immunodeficiency virus (HIV). Note:
baseline HIV screening is not required

- The subject is unable or unwilling to abide by the study protocol or cooperate fully
with the investigator or designee.

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Safety Issue:


Principal Investigator

Angela DiMichele, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Food and Drug Administration

Study ID:

UPCC 02112



Start Date:

April 2012

Completion Date:

April 2015

Related Keywords:

  • Estrogen-receptor Positive Invasive Metastatic Breast Cancer
  • Postmenopausal female
  • Breast Neoplasms



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283