Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/16/2018
Start Date:April 14, 2009
End Date:March 22, 2018

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

A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer

This open label study is designed to evaluate Lapatinib effect on incidence of brain
metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior
taxanes or anthracyclines.


Inclusion Criteria:

- Females at least 18 years old;

- ECOG Performance Status 0-2;

- Histologically or cytologically confirmed HER2-positive invasive breast cancer, with
Stage IV disease;

- Prior treatment with taxanes or anthracyclines is required;

- Prior treatment with other chemotherapeutic agents, trastuzumab, endocrine and
radiation therapy is permitted;

- Baseline LVEF ≥ 50% and not lower than the institutional lower limit of normal;

- Concurrent treatment with bisphosphonates is permitted, however treatment must be
initiated prior to the first dose of study therapy;

- Able to swallow and retain oral medications;

- Women with potential to have children must be willing to practice acceptable methods
of birth control during the study;

- Normal organ and marrow function.

Exclusion Criteria:

- History and/or current evidence of CNS metastases. Baseline MRI scan by Independent
Reviewer to confirm no brain mets;

- Concurrent treatment with an investigational agent or participation in another
treatment clinical trial;

- Prior therapy with lapatinib or an ErbB2 inhibitor other than trastuzumab (including
but not limited to trastuzumab-DM1 and neratinib) and capecitabine;

- Known DPD deficiency;

- Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy, or
hormonal therapy for treatment of cancer;

- History of allergic reactions attributed to compounds chemically related to lapatinib
(quinazolines), capecitabine, fluorouracil or any excipients;

- Concomitant use of CYP3A4 inhibitors or inducers;

- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel;

- History of immediate or delayed hypersensitivity reaction to gadolinium contrast
agents, or other contraindication to gadolinium contrast and other known
contraindication to MRI;

- Concurrent disease or condition that would make the subject inappropriate for study
participation or any serious medical or psychiatric disorder that would interfere with
the patient's safety or compliance to study procedures;

- have acute or currently active/requiring anti-viral therapy hepatic or biliary disease
(with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver
metastases or stable chronic liver disease);

- Any on-going toxicity from prior anti cancer therapy except alopecia;

- Active cardiac disease;

- Uncontrolled infection;

- History of other malignancy, unless curatively treated with no evidence of disease for
at least 5 years, subjects with adequately treated DCIS or LCIS, adequately treated
non-melanoma skin cancer or curatively treated in-situ cancer of the cervix are
eligible;

- Used an investigational drug within 30 days or 5 half-lives, whichever is longer,
preceding the first dose of protocol treatment;

- Pregnant or lactating females.
We found this trial at
18
sites
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Antwerpen,
Click here to add this to my saved trials
Boca Raton, Florida 33486
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Coral Springs, Florida 33065
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
Goodyear, Arizona 85338
?
mi
from
Goodyear, AZ
Click here to add this to my saved trials
Great Falls, Montana 59405
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
Greenbrae, California 94904
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63128
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Santa Barbara, California 93108
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
Tucson, Arizona 85745
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Voorhees, New Jersey 08043
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
Warrenville, Illinois 60555
?
mi
from
Warrenville, IL
Click here to add this to my saved trials
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials