Neoadjuvant GW572016 to Treat Breast Cancer (GW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206427
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : March 7, 2012
Last Update Posted : July 31, 2013
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center

Brief Summary:
We want to learn whether GW572016 is effective in breast cancers that have HER2.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: GW572016 Drug: lapatinib Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Neoadjuvant Phase II Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients: Biologic Correlative Study
Study Start Date : August 2004
Actual Primary Completion Date : June 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Intervention
Intervention/Lapatinib (GW572016)
Drug: GW572016
Lapatinib, 500 mg
Other Names:
  • TyKerb
  • Lapatinib

Drug: lapatinib
Lapatinib 500 mg PO
Other Names:
  • TyKerb
  • GW572016

Primary Outcome Measures :
  1. Clinical Response [ Time Frame: at the end of week 6. ]
    Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).

Secondary Outcome Measures :
  1. If GW572016 Inhibits HER1 and HER2 Signaling in Situ. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. All patients must be female.
  2. Signed informed consent.
  3. Locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size >/- 5 cm, and/or are deemed surgically inoperable, with Stage IIIb, IIIc, or IV disease.
  4. HER2 overexpressing tumors defined as HercepTest score of 3+, or >/- 10% cells moderately or strongly HER2 positive by other methods, or semi-quantitative score of >/- 5 (in Dr. Allred's laboratory) or gene amplified.
  5. Negative serum pregnancy test (BHCG) within 7 days of starting study, if of child-bearing potential.
  6. Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.
  7. Performance status (WHO scale) less than 2 and life expectancy greater than 6 months.
  8. Age greater than 18 years.
  9. No brain or leptomeningeal disease.
  10. No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated core-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

Exclusion Criteria:

  1. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
  2. Severe underlying chronic illness or disease.
  3. Cardiomyopathy or baseline LVEF <50%.
  4. Other investigational drugs while on study.
  5. Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
  6. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.
  7. Taking any GW572016-prohibited medication (see GW572016 Prohibited Medications List in protocol) within 7 days of first dose of study medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206427

United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Texas
Baylor Breast Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor Breast Care Center
Principal Investigator: Mothaffar Rimawi, MD Baylor Breast Center

Additional Information:
Responsible Party: Mothaffar Rimawi, Medical Director, Baylor Breast Care Center Identifier: NCT00206427     History of Changes
Other Study ID Numbers: H 15430
Neoadjuvant GW572016 ( Other Identifier: Baylor Breast Center )
First Posted: September 21, 2005    Key Record Dates
Results First Posted: March 7, 2012
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Mothaffar Rimawi, Baylor Breast Care Center:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action