A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:February 26, 2013
End Date:July 30, 2018

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Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With ER+Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.

This was a three-arm, randomized, open label, multi-center phase II study investigating the
combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg
daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with
estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or
progression on letrozole or anastrozole.

The reference therapy (control arm) used in the course of this trial was the combination arm
of everolimus plus exemestane. The investigational therapies in the context of this study
were everolimus monotherapy and capecitabine monotherapy. All treatments were taken orally
until disease progression, intolerable toxicity or withdrawal of patient's informed consent.
Patients were randomly assigned with equal allocation to one of the treatment arms:

1. Exemestane (25mg daily) in combination with everolimus (10mg daily)

2. Everolimus (10mg daily)

3. Capecitabine (1250mg/m2 twice daily) orally for two weeks, followed by a one week rest
period in 3-weeks cycles.

Treatment assignment was stratified by the presence of visceral disease (yes vs. no).
Visceral refered to lung, liver, heart, ovary, spleen, kidney, adrenal gland, malignant
pleural or pericardial effusion or malignant ascites.

Key Inclusion Criteria:

-Women with locally advanced, recurrent, or metastatic breast cancer along with
confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least
one lesion ≥ 10 mm by CT or MRI that can be accurately measured in at least one dimension
(CT scan slice thickness ≤ 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the
absence of measurable disease as defined above

Key Exclusion Criteria:

-Patients who received more than one chemotherapy line. Patients with only non-measurable
lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment
with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors
We found this trial at
22
sites
Germantown, Tennessee 38138
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Germantown, TN
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Burlington, Massachusetts 01805
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Burlington, MA
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Caba, Buenos Aires
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Caba,
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Charlottesville, Virginia 22908
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Charlottesville, VA
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Chattanooga, TN
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Cincinnati, OH
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Elizabeth, New Jersey 07207
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Elizabeth, NJ
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Fort Myers, FL
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Fort Myers, FL
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Fort Worth, TX
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Hackensack, NJ
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Kalispell, MT
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Knoxville, Tennessee 27920
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Knoxville, TN
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Los Angeles, CA
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Nashville, Tennessee 37203
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Nashville, TN
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Newark, New Jersey 07101
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Newark, NJ
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Newton, MA
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Sacramento, California 95817
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Sacramento, CA
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San Diego, CA
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Tacoma, WA
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Tulsa, OK
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Westminster, Maryland 21157
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Westminster, MD
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