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

Use our guide to learn which trials are right for you!

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
Fairfax, Virginia 22031
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Phone: 772-408-5164
?
mi
from
Port Saint Lucie, FL
Click here to add this to my saved trials
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...
?
mi
from
Portland, OR
Click here to add this to my saved trials
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...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
220 S Palisade Dr # 204
Santa Maria, California 93454
?
mi
from
Santa Maria, CA
Click here to add this to my saved trials
22 South Greene Street
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Birmingham, Alabama 35223
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Charleston, South Carolina 29403
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Corona, California 92879
?
mi
from
Corona, CA
Click here to add this to my saved trials
Corpus Christi, Texas 78463
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Corpus Christi, Texas 78412
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Corvallis, OR
Click here to add this to my saved trials
?
mi
from
Decatur, IL
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
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...
?
mi
from
Harvey, IL
Click here to add this to my saved trials
45 Hospital Center Commons
Hilton Head Island, South Carolina 29926
?
mi
from
Hilton Head Island, SC
Click here to add this to my saved trials
Hollywood, Florida
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
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...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46254
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Lewiston, Maine 04240
?
mi
from
Lewiston, ME
Click here to add this to my saved trials
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...
?
mi
from
Livingston, NJ
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
Neptune, New Jersey 07754
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
New Brunswick, New Jersey 08903
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
Newnan, Georgia 30265
?
mi
from
Newnan, GA
Click here to add this to my saved trials
North Platte, Nebraska 69101
?
mi
from
North Platte, NE
Click here to add this to my saved trials
Ogden, Utah 84403
?
mi
from
Ogden, UT
Click here to add this to my saved trials
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...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plantation, Florida
?
mi
from
Plantation, FL
Click here to add this to my saved trials
7000 Boulder Avenue
Redlands, California 92373
?
mi
from
Redlands, CA
Click here to add this to my saved trials
?
mi
from
Redondo Beach, CA
Click here to add this to my saved trials
Riverside, California 92501
?
mi
from
Riverside, CA
Click here to add this to my saved trials
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...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84106
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Barbara, California 93105
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Sunrise, Florida 33322
?
mi
from
Sunrise, FL
Click here to add this to my saved trials
961 South Gloster Street
Tupelo, Mississippi 38801
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Voorhees, New Jersey 08403
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
185 Fox Valley Road
Wahroonga, New South Wales 2076
?
mi
from
Wahroonga,
Click here to add this to my saved trials