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A Randomized, Double Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing the Activity of Paclitaxel Plus Trastuzumab Plus Lapatinib to Paclitaxel Plus Trastuzumab Plus Placebo in Women With ErbB2 Overexpressing Metastatic Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Neoplasms, Breast

Thank you

Trial Information

A Randomized, Double Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing the Activity of Paclitaxel Plus Trastuzumab Plus Lapatinib to Paclitaxel Plus Trastuzumab Plus Placebo in Women With ErbB2 Overexpressing Metastatic Breast Cancer

Inclusion Criteria


Inclusion criteria:

- Histologically confirmed invasive breast cancer with stage IV disease If trastuzumab
was administered in the adjuvant setting, >12 months must have elapsed since
discontinuation of trastuzumab therapy

- If a taxane was administered in the neoadjuvant or adjuvant setting, progression must
have occurred 12 months after completion of this treatment

- Had tumors that overexpress ErbB2 (Immunohistochemistry 3+ or Fluorescent in-situ
hybridisation gene amplification)

- Patients must have tumor tissue available for central testing Measurable lesion(s)

- Subjects must be females of at least 18 years Non-childbearing potential or
Childbearing potential but using adequate contraception

- Radiotherapy to a limited area other than the sole site of measurable and assessable
disease is allowed; however, patients must have completed treatment and recovered
from all acute treatment-related toxicities prior to administration of the first dose
of study medication

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

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1

- For those patients whose disease is estrogen receptor positive+ and/or progesterone
receptor + one the following criteria should be met: Patients with visceral disease
that requires chemotherapy (eg., patients with liver or lung metastases) or Rapidly
progressing/life threatening disease, as determined by the investigator or Patients
who received hormonal therapy and are no longer benefiting from this therapy;

- Able to swallow and retain oral medication

- Cardiac ejection fraction within institutional range of normal

- Patient must have adequate organ function

Exclusion criteria:

- Pregnant or lactating females;

- Received prior chemotherapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2
therapy for metastatic disease, prior hormonal therapy is permitted but must be
discontinued a minimum of 7 days prior to randomization; Malabsorption syndrome,
disease significantly affecting gastrointestinal function, or resection of the
stomach or small bowel.

- Patients with ulcerative colitis are also excluded;

- History of other malignancy; however, patients who have been disease-free for five
years, or patients 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 patient inappropriate for study
participation, or any serious medical disorder that would interfere with the
patient's safety;

- 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;

- Active or 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, conduction
abnormalities or congestive heart failure;

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

- Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic
therapy, hormonal therapy); Concurrent treatment with an investigational agent or
participation in another clinical trial;

- Concurrent treatment with any medication on the prohibited medications list.

- Used an investigational drug within 30 days or 5 half-lives, whichever is longer,
preceding the first dose of treatment. Hormonal therapy needs to be discontinued at
least 7 days before the first dose of treatment.

- Prior therapy with an ErbB2 inhibitor, other than trastuzumab in the adjuvant
setting;

- A known immediate or delayed hypersensitivity reaction to drugs chemically related to
lapatinib or excipients;

- A known immediate or delayed hypersensitivity reaction to drugs chemically related to
paclitaxel or excipients;

- A known immediate or delayed hypersensitivity reaction to drugs chemically related to
trastuzumab or excipients;

- Non compliance with any of the screening procedures

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:

Incidence of adverse events

Outcome Time Frame:

Patients have completed at least 16 weeks of treatment

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

EGF104383

NCT ID:

NCT00272987

Start Date:

December 2005

Completion Date:

July 2012

Related Keywords:

  • Neoplasms, Breast
  • lapatinib
  • metastatic breast cancer
  • Taxol
  • ErbB1
  • trastuzumab
  • ErbB2
  • paclitaxel
  • Herceptin
  • Stage IV breast cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteLexington, Kentucky  40536-0098
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteOklahoma City, Oklahoma  73112
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteHattiesburg, Mississippi  39401
GSK Investigational SiteEdison, New Jersey  08837