Status:
COMPLETED
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR p...
Detailed Description
Subjects were randomly assigned to receive either lapatinib (1500 mg once daily orally) with letrozole (2.5 mg once daily orally), or letrozole (2.5 mg once daily orally) with placebo (which matched w...
Eligibility Criteria
Inclusion
- Key inclusion criteria
- Signed informed consent;
- Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;
- Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
- If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.
- Tumors that were ER+ and/or PgR+;
- Post-menopausal female subjects ≥ 18 years of age.
- ECOG Performance Status of 0 or 1;
- Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.
- Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (\>12 months) to the first dose of randomized therapy.
- Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.
- Key exclusion criteria:
- Pre-menopausal, pregnant, or lactating;
- Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;
- Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted;
- Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);
- Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)
- Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
Exclusion
Key Trial Info
Start Date :
December 9 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2018
Estimated Enrollment :
1286 Patients enrolled
Trial Details
Trial ID
NCT00073528
Start Date
December 9 2003
End Date
March 22 2018
Last Update
February 24 2021
Active Locations (278)
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1
Novartis Investigative Site
Tucson, Arizona, United States, 85715
2
Novartis Investigative Site
Hot Springs, Arkansas, United States, 71913
3
Novartis Investigative Site
Jonesboro, Arkansas, United States, 72401
4
Novartis Investigative Site
Alhambra, California, United States, 91801