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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Neoplasms, Breast

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

EGF20008

NCT ID:

NCT00062686

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Neoplasms, Breast
  • Lapatinib
  • Metastatic Breast Cancer
  • HERCEPTIN refractory
  • Breast Neoplasms
  • Neoplasms

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