An open-label, single-arm, multicentre, Phase II study of oral lapatinib in combination with paclitaxel as first-line treatment for ErbB2-amplified metastatic breast cancer patients - Phase II study of paclitaxel plus lapatinib in patients with ErbB2-amplified metastatic breast cance

GlaxoSmithKline R&D Ltd0 sites56 target enrollmentFebruary 6, 2006

ConditionsMetastatic breast cancer

DrugsTaxol

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic breast cancer
Sponsor: GlaxoSmithKline R&D Ltd
Enrollment: 56
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 6, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

GlaxoSmithKline R&D Ltd

Eligibility Criteria

Inclusion Criteria

•\- Able to give signed informed consent
•\- Female, aged \>\=18years; if of child\-bearing potential, the patient must have a negative serum pregnancy test and agree to use a protocol\-defined acceptable method of birth control
•\- Histologically\-confirmed Stage IV invasive breast cancer; where the disease is restricted to a solitary lesion, the neoplastic nature should be confirmed
•\- Patients with ER\+ and/or PR\+ disease or of unknown status will only be included if: they have symptomatic visceral disease requiring chemotherapy; the disease is rapidly progressing or life\-threatening; the patient has received endocrine therapy but is no longer benefiting from this therapy
•\- Documented amplification of ErbB2 by FISH in primary or metastatic tumour tissue
•\- If prior taxane received in the adjuvant or neoadjuvant setting, disease progression must have occurred \>\=12months after completion of this treatment
•\- Measurable lesions according to RECIST
•\- Radiotherapy prior to start of study medication is allowed to a limited area if not the sole site of disease. Patients must have completed radiation treatment and recovered from all associated toxicities
•\- Bisphosphonate therapy for bone metastases is allowed provided this treatment was initiated before statrting study medication. Prophylactic bisphosphonate therapy is not permitted, except for osteoporosis.
•\- CNS metastases must be stable for at least 3months; patients with leptomeningeal involvement are only eligible if not taking oral steroids or enzyme\-inducing anticonvulsants

Exclusion Criteria

•\- Pregnant or lactating
•\- Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy for metastatic disease
•\- Prior therapy with ErbB1 and/or ErbB2 inhibitors
•\- Concurrent anti\-cancer therapy while taking study medication
•\- Unresolved or unstable, serious toxicity from prior administration of another IMP or cancer treatment
•\- \>\= Grade 2 peripheral neuropathy
•\- Malabsorption syndrome, disease significantly affecting GI function, or resection of stomach or small bowel. Patients with ulcerative colitis will be excluded.
•\- History of other malignancy (unless disease\-free for \>\=5years, or history of completely resected non\-melanoma skin cancer or successfully treated in situ carcinoma)
•\- Concurrent disease or condition that would make the patient inappropriate for participation in the study
•\- Active or uncontrolled infection