A Phase II Trial of Lapatinib and Trastuzumab With or Without Endocrine Therapy in Locally Advanced HER2 Overexpressing Breast Cancer Patients - Full Text View

Sponsors and Collaborators:	Baylor Breast Care Center GlaxoSmithKline
Information provided by:	Baylor Breast Care Center
ClinicalTrials.gov Identifier:	NCT00548184

Purpose

We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen receptor positive (ER positive), estrogen deprivation will also be given to you.

Tumors that are ER positive have a lot of estrogen receptors found in them. This is also called "over expression" or amplification of estrogen receptors.

The most important information we will get from this study is to see the response to "neoadjuvant" (treatment given before the main treatment), lapatinib with trastuzumab (herceptin) in your tumor tissue sample.

Condition	Intervention	Phase
Breast Cancer	Drug: Lapatinib Drug: Trastuzumab Drug: Endocrine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Phase II Trial of Lapatinib and Trastuzumab With or Without Endocrine Therapy in Locally Advanced HER2 Overexpressing Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab Lapatinib Lapatinib Ditosylate

U.S. FDA Resources

Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:

Data Analysis of the Biomarkers: Immunohistochemical staining of cells from breast biopsies and skin biopsies will be performed. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy, the patients will undergo definitive surgery. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2020
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Intervention Details:

Monoclonal antibody

Hormonal Therapy

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients must be female.
Signed informed consent.
Locally advanced breast cancers or primary breast cancers are eligible. Locally advanced cancers must be of clinical and/or radiologic size >3 cm, or >2 cm with clinical evidence of axillary nodal involvement. (If tumors are less than 3 cm, we will use radiologically measured tumor size to determine the minimal tumor size for eligibility and in assessing tumor size during follow-up).
HER2 overexpressing tumors defined as HercepTest score of 3+, or > 10% cells moderately or strongly HER2 positive by other methods, or Allred semi-quantitative score of >5, or gene amplified.
Negative serum pregnancy test (HCG) within 7 days of starting study, if of child-bearing potential.
Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.
Performance status (WHO scale) less than 2 and life expectancy more than 6 months.
Age at least 18 years.
No brain or leptomeningeal disease.
No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

Note: The presence of pathological involvement of axillary nodes will be assessed and agreed upon by two investigators.

Exclusion Criteria:

Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
Severe underlying chronic illness or disease.
Cardiomyopathy or baseline LVEF less than 50%.
Other investigational drugs while on study.
Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded
Taking any lapatinib-prohibited medication within 7 days of first dose of study medications. (See Prohibited Medications List in protocol.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548184

Contacts

Contact: Anne C Pavlick, BS	713-798-7770	acpavlic@breastcenter.tmc.edu
Contact: Brenda Reusser, BA	713-798-1929	breusser@breastcenter.tmc.edu

Locations

United States, Alabama
UAB Cancer Center	Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Pam Dixon 205-975-5387 PaPam.Dixon@ccc.uab.edu
Principal Investigator: Andres Forero, MD
United States, Illinois
The University of Chicago	Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Amanda Spratt, CCRP 773-834-4031 aspratt@medicine.bsd.uchicago.edu
Contact: Erin Mueller (773)702-0859 emueller@medicine.bsd.uchicago.edu
Principal Investigator: Rita Nanda, MD
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bunting-Blaustein Cancer Research	Not yet recruiting
Baltimore, Maryland, United States, 21231-1000
Contact: Stacie Jeter, CCRP 410-614-6138 sjeter1@jhmi.edu
Principal Investigator: Antonio C Wolf, MD
United States, Minnesota
Mayo Clinic Cancer Center	Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Rochelle Kozera 507-538-8267 kozera.rochelle@mayo.edu
Principal Investigator: James Ingle, MD
United States, Tennessee
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6868
Contact: Kerek E Frierson 615-322-5092 kerek.frierson@vanderbilt.edu
Principal Investigator: Ingrid A Mayer, MD
United States, Texas
Baylor College of Medicine, Lester and Sue Smith Breast Center	Recruiting
Houston, Texas, United States, 77030
Contact: Anne Pavlick, BS 713-798-1999 acpavlic@bcm.tmc.edu
Principal Investigator: Jenny Chang, MD

Sponsors and Collaborators

Baylor Breast Care Center

GlaxoSmithKline

Investigators

Principal Investigator:

Jenny C Chang, MD

Baylor Breast Center

More Information

No publications provided

Responsible Party:	Baylor College of Medicine ( Jenny Chang )
Study ID Numbers:	H-20464
Study First Received:	October 19, 2007
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00548184 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baylor Breast Care Center:

primary breast cancers
Locally advanced breast cancers

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Skin Diseases
Trastuzumab
Breast Neoplasms

Lapatinib
Protein Kinase Inhibitors
Breast Diseases
Immunoglobulins

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Lapatinib
Enzyme Inhibitors
Protein Kinase Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Trastuzumab
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009