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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Her2+, Metastatic Breast Cancer, Neoplasms, Breast, Cancer, ErbB2+

Thank you

Trial Information

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer

Patients must with Her2+(ErbB2+) MBC Stage IV, newly diagnosed will receive
paclitaxel+lapatinib or paclitaxel plus placebo for 6 cycles minimum. After 6 cycles
continue to receive blinded monotherapy until progression. Safety evaluations include
evaluating adverse events, hematology/ chemistry tests, vital signs, and cardiac muga scans.
Efficacy assessments include evaluation of disease per RECIST. All patients followed for
overall survival (OS).

Study conducted in regions were access to trastuzumab is limited.

Inclusion Criteria

Inclusion criteria:

- Signed informed consent;

- Male or female ≥18 years;

- Histologically confirmed invasive breast cancer with stage IV disease; If the disease
is restricted to a solitary lesion, its neoplastic nature should be confirmed by
cytology or histology.

- Documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in
primary or metastatic tumor tissue by the central laboratory for randomization into
the study;

- If a taxane was administered in the neoadjuvant or adjuvant setting, progression must
have occurred >12 months after completion of this treatment and the patient recovered
from all associated toxicities;

- Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid

- Radiotherapy as palliative treatment for painful metastatic disease is permitted but
must have been stopped within 2 weeks prior to initiation of any investigational
treatment. All subjects must have recovered from all radiotherapy related toxicities
prior to initiation of any investigational treatment. The site of radiotherapy must
not be used as a site of measurable disease;

- Bisphosphonate therapy for bone metastases and is allowed; however, treatment must be
initiated prior to the first dose of investigational treatment. Prophylactic use of
bisphosphonates in subjects without bone disease is not permitted, except for the
treatment of osteoporosis;

- For those patients whose disease is ER+ and/or PR+ the following criteria should be

Patients with visceral disease that requires chemotherapy (eg., patients with liver or
lung metastases) Rapidly progressing or life threatening disease, as determined by the
investigator Patients who received hormonal therapy and are no longer benefiting from this
therapy and the hormonal treatment must have been stopped before the first dose of
investigational treatment;

- Cardiac ejection fraction within institutional range of normal as measured by
echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot
be performed or is inconclusive;

- ECOG Performance Status of 0 to 1;

- Life expectancy of ≥ 12 weeks;

- Able to swallow and retain oral medication;

- Archived tumor tissue available for testing;

- Women and men with potential to have children must be willing to practice acceptable
methods of birth control during the study;

- Willing to complete all screening assessments as outlined in the protocol;

- Adequate organ function as defined in Table 1 Baseline Laboratory Values;

Exclusion Criteria:

- Pregnant or lactating females at anytime during the study

- Subjects with only non-measurable metastatic sites of disease per RECIST, (e.g. bone
metastases, pleural effusion, or ascites, etc. (Refer to Section 5.3 Efficacy for
list sites considered to be non-measurable disease.);

- Received prior chemotherapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2
therapy for metastatic disease.

- Prior therapy with an ErbB1 and/or ErbB2 inhibitor, other than trastuzumab in the
adjuvant setting. If trastuzumab was administered in the adjuvant setting, then > 12
months must have elapsed since completion of trastuzumab therapy;

- Planned concurrent anti-cancer therapy (chemotherapy, radiation therapy,
immunotherapy, biologic therapy, hormonal therapy) while taking investigational

- Unresolved or unstable, serious toxicity from prior administration of another
investigational drug and/or of prior cancer treatment;

- Peripheral neuropathy of Grade 2 or greater;

- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel. Subjects with ulcerative colitis are also

- History of other malignancy. However, subjects who have been disease-free for 5
years, or subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma, are eligible;

- Concurrent disease or condition that would make the subject inappropriate for study
participation, or any serious medical disorder that would interfere with the
subject's safety;

- Uncontrolled infection;

- Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent;

- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart

- Known history or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis;

- Concurrent treatment with prohibited medications, including herbal remedies and
Chinese traditional medicines;

- Concurrent treatment with an investigational agent or participation in another
clinical trial involving investigational agents;

- Used an investigational drug within 30 days or 5 half-lives, whichever is longer,
preceding the first dose of investigational treatment;

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to paclitaxel or lapatinib or their excipients.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Overall survival is defined as the time from randomization until death due to any cause.

Outcome Time Frame:

Randomization to death (up to maximum of Month 53)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Ukraine: Central Ethics Committee;

Study ID:




Start Date:

January 2006

Completion Date:

December 2013

Related Keywords:

  • Her2+
  • Metastatic Breast Cancer
  • Neoplasms, Breast
  • Cancer
  • ErbB2+
  • ErbB2 positive
  • Her2+
  • metastatic breast cancer
  • FISH positive
  • Stage IV
  • Breast Neoplasms
  • Neoplasms