A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide



Status:Recruiting
Conditions:Breast Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:February 2015
End Date:March 2020
Contact:Puma Biotechnology, Inc.
Email:clinicaltrials@pumabiotechnology.com
Phone:(424) 248-6500

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An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with
Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide

This is an open-label, Phase 2 study that will investigate the incidence and severity of
diarrhea in early-stage HER2+ breast cancer patients receiving neratinib with loperamide,
alone and in combination with an anti-inflammatory treatment or a bile acid sequestrant
treatment, who have previously undergone a course of trastuzumab therapy in the adjuvant
setting.

Patients will receive:

- Neratinib 240 mg orally once daily with food for thirteen (13) 28-day cycles.

- Loperamide daily for two (2) 28-day cycles and then as needed.

- Amendment 3, an anti-inflammatory treatment for 1 cycle and loperamide to be
administered daily for two (2) 28-day cycles and then as needed. Closed to enrollment.

- Amendment 4, colestipol for 1 cycle and loperamide to be administered 1 cycle and then
as needed. Closed to enrollment.

- Amendment 5, colestipol for 1 cycle and loperamide as needed. Closed to enrollment.

- Amendment 6/6.1, 120 mg neratinib for Week 1 (C1D1-C1D7), followed by 160 mg neratinib
for Week 2 (C1D8- C1D14), followed by 240 mg neratinib for Week 3 and thereafter (C1D15
to end of treatment). Loperamide as needed.

- Amendment 7, 160 mg neratinib for the first 2 weeks (C1D1 - C1D14), followed by 200 mg
neratinib for the next 2 weeks (C1D15 - C1D28), followed by 240 mg neratinib thereafter
(C2D1 to end of treatment). Loperamide as needed.

Inclusion Criteria:

- Age ≥18; male or female, early breast cancer (stage I-3c)

- Documented HER2+ tumor1: HER2 immunohistochemistry (IHC) 3+ or ISH+

- Documented hormone receptor (HR)-positive disease, defined as estrogen receptor
(ER)-positive and/or progesterone (PR)-positive (for patients enrolled starting with
Amendment 7.0)

- Prior course of adjuvant trastuzumab given >2 weeks and ≤1 from enrollment

- No evidence of local/regional recurrence or metastatic disease

- Radiologic assessment (Chest X-ray at a minimum) others if abnormal labs during
screening

- Eastern Cooperative Oncology Group (ECOG) PS ≤1 (0 or 1)

- Endocrine therapy and other prior HER2-directed therapy, including pertuzumab, TDM-1
is permitted

- Male patient with female partners of childbearing potential must agree and commit to
use a condom and Women of childbearing potential must agree and commit to the use of a
highly effective non-hormonal method of contraception

Exclusion Criteria:

- Major surgery < 30 days

- Chemotherapy, investigational agents, other cancer therapy < 14 days

- Normal Left Ventricular Ejection Fraction (LVEF) < 50%, Corrected QT Interval (QTc)
>0.450 seconds (males) or >0.470 (females) or other active cardiac disease

- Significant chronic GI disorder with diarrhea as a major symptom

- No evidence of metastatic breast cancer with negative chest x-ray and other imaging if
abnormal lab value
We found this trial at
45
sites
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Phone: 772-408-5164
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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220 S Palisade Dr # 204
Santa Maria, California 93454
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22 South Greene Street
Baltimore, Maryland 21201
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Birmingham, Alabama 35223
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Charleston, South Carolina 29403
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Corona, California 92879
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Corpus Christi, Texas 78463
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Corpus Christi, Texas 78412
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Fairfax, Virginia 22031
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Fullerton, California 92835
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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45 Hospital Center Commons
Hilton Head Island, South Carolina 29926
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Hollywood, Florida
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46254
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Lake Success, New York 11042
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Lewiston, Maine 04240
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Los Angeles, California 90095
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Louisville, Kentucky 40207
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Mission Hills, California 91345
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Neptune, New Jersey 07754
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New Brunswick, New Jersey 08903
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Newnan, Georgia 30265
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North Platte, Nebraska 69101
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Ogden, Utah 84403
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Plantation, Florida
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7000 Boulder Avenue
Redlands, California 92373
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Riverside, California 92501
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84106
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Santa Ana, California 92705
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Santa Barbara, California 93105
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Sunrise, Florida 33322
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961 South Gloster Street
Tupelo, Mississippi 38801
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Voorhees, New Jersey 08403
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185 Fox Valley Road
Wahroonga, New South Wales 2076
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