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Neoadjuvant GW572016 to Treat Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00206427
First received: September 14, 2005
Last updated: February 3, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Drug: GW572016
Drug: lapatinib
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Neoadjuvant Phase II Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients: Biologic Correlative Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: at the end of week 6. ] [ Designated as safety issue: No ]
    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:
  • If GW572016 Inhibits HER1 and HER2 Signaling in Situ. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: August 2004
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW572016
    Lapatinib, 500 mg
    Other Names:
    • TyKerb
    • Lapatinib
    • GW572016
    Drug: lapatinib
    Lapatinib 500 mg PO
    Other Names:
    • TyKerb
    • GW572016
    • Lapatinib
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206427

Locations
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
GlaxoSmithKline
Investigators
Principal Investigator: Mothaffar Rimawi, MD Baylor Breast Center
  More Information

Additional Information:
Web site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mothaffar Rimawi, Medical Director, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00206427     History of Changes
Other Study ID Numbers: H 15430, Neoadjuvant GW572016
Study First Received: September 14, 2005
Results First Received: February 3, 2012
Last Updated: February 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Breast Care Center:
Advanced
Breast
Cancer
Neoadjuvant
HER2

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

ClinicalTrials.gov processed this record on May 19, 2013