GW572016 For Treatment Of Refractory Metastatic Breast Cancer

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: NCT00062686
Recruitment Status : Completed
First Posted : June 12, 2003
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):

June 11, 2003
June 12, 2003
April 15, 2015
November 2003
February 2005   (Final data collection date for primary outcome measure)
Tumor response rate
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Complete list of historical versions of study NCT00062686 on Archive Site
clinical benefit rate time to progression 4 and 6 month progression free survival overall survival
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GW572016 For Treatment Of Refractory Metastatic Breast Cancer
An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens
This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms, Breast
Drug: GW572016
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2005
February 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed Informed Consent.
  • Histologically confirmed Stage IIIb or IV breast cancer.
  • Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
  • Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
  • Documented disease progression of the most recent treatment is required.
  • Archived tumor tissue available for testing.
  • Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
  • At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
  • Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
  • Able to swallow and retain oral medication.
  • Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
  • Adequate kidney and liver function.
  • Adequate bone marrow function.

Exclusion criteria:

  • Pregnant or lactating.
  • Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
  • Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
  • History of other malignancy.
  • Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
  • Active or uncontrolled infection.
  • Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
  • Known history of or clinical evidence of leptomeningeal carcinomatosis.
  • Active infection.
  • Concurrent cancer therapy or investigational therapy.
  • Use of oral or IV steroids.
  • Unresolved or unstable serious toxicity from prior therapy.
  • Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Argentina,   France,   Germany,   United Kingdom
Australia,   Belgium,   Canada,   Greece,   Japan,   Spain,   United States
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Study Director: GSK Clinical Trials GlaxoSmithKline
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP