View Clinical Trial (Medical Research Study)

Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive - NCT00390455-54601(Clinical Trial 153543)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  La Crosse
State:  
WI
Zip Code: 54601
Conditions: Breast Cancer
Purpose: RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer. PURPOSE: This randomized phase III trial is studying fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive.
Study summary: OBJECTIVES: Primary - Compare the progression-free survival of postmenopausal women with stage III or IV hormone receptor-positive breast cancer treated with fulvestrant with or without lapatinib ditosylate. Secondary - Compare the response rate in patients treated with these regimens. - Compare response and stable disease rate (i.e., complete response, partial response, and stable disease > 6 months) in patients treated with these regimens. - Compare the duration of response in patients treated with these regimens. - Compare the overall survival of patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. OUTLINE: This is a multicenter, open-label, randomized, double-blind, placebo-controlled study. Patients are stratified according to prior tamoxifen citrate therapy (yes vs no) and bone disease only (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral lapatinib ditosylate once daily on days 1-28 and fulvestrant intramuscularly (IM) on days 1 and 15 of course 1 and on day 1 of each subsequent course. - Arm II: Patients receive oral placebo once daily on days 1-28 and fulvestrant as in arm I. In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then on day 1 of every 2 courses of treatment (i.e., day 1 of courses 3, 5, 7, etc.). After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study.
Criteria: DISEASE CHARACTERISTICS: - Histologically* or cytologically confirmed breast cancer, meeting 1 of the following stage criteria: - Stage III (locally advanced) disease not considered amenable to curative therapy - Stage IV (primary or metastatic) disease NOTE: *Histological documentation of recurrent/metastatic disease is not required if there is clinical evidence of recurrence - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan - Lytic or blastic bone metastases as only site of disease allowed - The following are not considered measurable disease: - Bone lesions (except as above) - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast cancer - Lymphangitis cutis/pulmonitis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Must have received prior therapy with 1 or 2 endocrine treatments for breast cancer in either the adjuvant or metastatic setting (not including treatment for ovarian suppression or amenorrhea) - Tumor must be potentially sensitive to endocrine therapy, defined as ≥ 3 months of prior endocrine therapy without disease progression in the adjuvant or metastatic setting - Treatments must have been commercially-available third-generation aromatase inhibitors (e.g., anastrozole, exemestane, or letrozole)* NOTE: *Sequential use of 2 different third-generation aromatase inhibitors is considered 1 prior treatment; it is not required that tumors be resistant to this treatment - No symptomatic brain or other CNS metastases - Previously treated brain metastases allowed provided patient is free of symptoms AND > 3 months since prior treatment for brain metastases - Hormone receptor status: - Estrogen receptor- and/or progesterone receptor-positive tumor by IHC methods (≥ 1% cells considered positive) PATIENT CHARACTERISTICS: - Female - Postmenopausal, meeting 1 of the following criteria: - Age ≥ 60 years - Age ≥ 45 years with an intact uterus and amenorrhea for ≥ 12 months - History of bilateral oophorectomy - Follicle-stimulating hormone levels within postmenopausal range - Undergoing treatment with a gonadotropin-releasing hormone agonist for ovarian suppression for ≥ 3 consecutive months prior to study entry, and remains on such therapy throughout study treatment - Life expectancy > 3 months - ECOG performance status 0-2 - Granulocyte count ≥ 1,000/mm³ - Platelet count ≥ 100,000/mm³ - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome) - Creatinine ≤ 2.0 mg/dL - AST and ALT ≤ 2.5 times ULN (5 times ULN for patients with liver metastases) - INR ≤ 1.6 - LVEF normal - Not pregnant or nursing - Negative pregnancy test - No pending visceral crisis - No acquired or inherited bleeding disorder PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 2 weeks since prior chemotherapy and recovered - Prior chemotherapy in the adjuvant and/or neoadjuvant setting allowed - No more than 1 prior chemotherapy regimen for stage IV breast cancer - At least 3 weeks since prior trastuzumab (Herceptin®) and recovered - Prior trastuzumab in the adjuvant and/or neoadjuvant setting allowed - No prior trastuzumab for stage IV breast cancer - No prior fulvestrant - No prior epidermal growth factor receptor (EGFR) inhibitors (e.g., gefitinib, erlotinib hydrochloride, lapatinib ditosylate, or cetuximab) - No other prior or concurrent experimental EGFR inhibitors - No other concurrent chemotherapy - No concurrent radiotherapy, including palliative radiotherapy - No other concurrent hormonal therapy* except for the following: - Steroids for adrenal failure - Hormones for nondisease-related conditions (e.g., insulin for diabetes or synthroid for hypothyroidism) - Intermittent dexamethasone as an antiemetic - No concurrent therapeutic systemic anticoagulation (defined as maintaining INR > 1.6) - Low-dose warfarin or acetylsalicylic acid (or equivalent) for maintenance of central venous catheter patency allowed - No other concurrent endocrine therapy, including systemic hormone-replacement therapy or intravaginal estrogen - Prior initiation of and concurrent bisphosphonate therapy allowed NOTE: *Patients receiving a gonadotropin-releasing hormone agonist for ovarian suppression must remain on therapy throughout the course of study treatment
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: July 12, 2010
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.