Know Cancer

forgot password

A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Metastases, Brain

Thank you

Trial Information

A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer

Inclusion Criteria:

- Females at least 18 years old;

- ECOG Performance Status 0-2;

- Histologically or cytologically confirmed HER2-positive invasive breast cancer, with
Stage IV disease;

- Prior treatment with taxanes or anthracyclines is required;

- Prior treatment with other chemotherapeutic agents, trastuzumab, endocrine and
radiation therapy is permitted;

- Baseline LVEF ≥ 50% and not lower than the institutional lower limit of normal;

- Concurrent treatment with bisphosphonates is permitted, however treatment must be
initiated prior to the first dose of study therapy;

- Able to swallow and retain oral medications;

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

- Normal organ and marrow function.

Exclusion Criteria:

- History and/or current evidence of CNS metastases. Baseline MRI scan by Independent
Reviewer to confirm no brain mets;

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

- Prior therapy with lapatinib or an ErbB2 inhibitor other than trastuzumab (including
but not limited to trastuzumab-DM1 and neratinib) and capecitabine;

- Known DPD deficiency;

- Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy, or
hormonal therapy for treatment of cancer;

- History of allergic reactions attributed to compounds chemically related to lapatinib
(quinazolines), capecitabine, fluorouracil or any excipients;

- Concomitant use of CYP3A4 inhibitors or inducers;

- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel;

- History of immediate or delayed hypersensitivity reaction to gadolinium contrast
agents, or other contraindication to gadolinium contrast and other known
contraindication to MRI;

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

- have acute or currently active/requiring anti-viral therapy hepatic or biliary
disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones,
liver metastases or stable chronic liver disease);

- Any on-going toxicity from prior anti cancer therapy except alopecia;

- Active cardiac disease;

- Uncontrolled infection;

- History of other malignancy, unless curatively treated with no evidence of disease
for at least 5 years, subjects with adequately treated DCIS or LCIS, adequately
treated non-melanoma skin cancer or curatively treated in-situ cancer of the cervix
are eligible;

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

- Pregnant or lactating females.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse

Outcome Description:

CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.

Outcome Time Frame:

From randomization until disease progression, death, or discontinuation from the study (average of 10 months)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

December 2016

Related Keywords:

  • Metastases, Brain
  • ErbB2
  • ErbB1
  • metastatic breast cancer
  • trastuzumab
  • breast cancer
  • capecitabine
  • lapatinib
  • brain metastases
  • HER2 positive
  • Breast Neoplasms
  • Neoplasm Metastasis