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Home > "A" Clinical Trials Conditions > Anastrozole With or Without Trastuzumab in Treating Postmenopausal Women With Metastatic Breast Cancer  Anastrozole With or Without Trastuzumab in Treating Postmenopausal Women With Metastatic Breast Cancer
Anastrozole With or Without Trastuzumab in Treating Postmenopausal Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether anastrozole is more effective with or without trastuzumab in treating metastatic breast cancer. PURPOSE: Randomizedphase II/III trial to compare the effectiveness of anastrozole plus trastuzumab with that of anastrozole alone in treating postmenopausal women who have metastatic breast cancer.
Details: OBJECTIVES: - Compare the efficacy of anastrozole with or without trastuzumab (Herceptin), in terms of progression-free survival, in postmenopausal women with hormone-receptor positive HER2-overexpressing metastatic breast cancer. - Compare the safety profile of these regimens in these patients. - Compare the overall clinical-benefit rate in patients treated with these regimens. - Compare the overall survival, duration of response, and 2-year survival of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to presence of liver metastases (yes vs no), tumor assessment (measurable disease vs evaluable disease), relapse after prior adjuvant tamoxifen therapy (no prior adjuvant tamoxifen therapy vs relapse at least 12 months after therapy vs relapse during or fewer than 12 months after therapy), and concurrent bisphosphonate therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral anastrozole once daily and trastuzumab (Herceptin) IV over 30-90 minutes once weekly. - Arm II: Patients receive anastrozole as in arm I. In both arms, treatment continues for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients in either arm who do not develop disease progression may continue receiving treatment, in the arm to which they were originally randomized, during the extension phase of this study. Patients in arm II who develop disease progression may receive treatment in arm I during the extension phase in the absence of further disease progression. Patients are followed at 28 days. PROJECTED ACCRUAL: A total of 202 patients (101 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic breast cancer - HER2 overexpression (3+) by immunohistochemistry OR - Any degree of erbB-2 amplification (at least 2 fold) by FISH - Measurable or evaluable disease - Postmenopausal as defined by any of the following: - At least 60 years of age - Under 60 years of age and amenorrheic for at least 12 months - Under 60 years of age, without a uterus, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) values within postmenopausal range - Menopausal age (under 60), amenorrheic for 12 months or less, and LH and FSH values within postmenopausal range - Prior bilateral oophorectomy - Prior radiation castration with amenorrhea for at least 6 months - No clinical or radiological evidence of CNS metastases - Hormone receptor status: - Estrogen-receptor positive AND/OR - Progesterone-receptor positive PATIENT CHARACTERISTICS: Age: - See Disease Characteristics - 18 and over Sex: - Female Menopausal status: - See Disease Characteristics Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm^3 - Neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 9 g/dL Hepatic: - Transaminases less than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: - Creatinine less than 1.5 times ULN Cardiovascular: - LVEF greater than 50% by echocardiogram or MUGA - No uncontrolled cardiac disease - No angina - No arrhythmias - No hypertension - No prior congestive heart failure - No myocardial infarction within the past 6 months Pulmonary: - No severe dyspnea at rest due to complications of advanced malignancy - No requirement for supplementary oxygen Other: - No concurrent uncontrolled serious illness - No other prior malignancy that would preclude study compliance - Patients with prior nonmelanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy allowed if disease free for more than 5 years - No clinical disease that requires immediate cytotoxic chemotherapy - No known allergy to Chinese hamster ovary cell proteins, murine proteins, or to any excipients of trastuzumab (Herceptin) formulation (e.g., l-histidine, trehalose dihydrate, or polysorbate 20) or preparation (e.g., benzyl alcohol) - Not pregnant or nursing - Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior anti-HER2 therapy - No other concurrent anticancer immunotherapy Chemotherapy: - At least 6 months since prior adjuvant chemotherapy - No prior chemotherapy for metastatic disease - No concurrent anticancer chemotherapy Endocrine therapy: - Prior first-line tamoxifen for metastatic disease allowed if partial or complete response or stable disease for more than 6 months - At least 1 day since prior tamoxifen - No more than 4 weeks (duration) of prior anastrozole - No concurrent steroid treatment for cancer - No concurrent hormone replacement therapy - No other concurrent anticancer hormonal therapy Radiotherapy: - See Disease Characteristics - No prior radiotherapy to indicator lesion, unless objective disease recurrence or progression within radiation portal since completion of radiotherapy - No concurrent radiotherapy to only known site of disease - Concurrent palliative radiotherapy allowed Surgery: - See Disease Characteristics - No concurrent resection of only known site of disease - Concurrent palliative surgery allowed Other: - At least 30 days since prior investigational drugs - Prior or concurrent bisphosphonate therapy allowed - No other concurrent specific anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BerndLanger, Study Chair, F. Hoffmann - La Roche, Ltd.
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Beth Overmoyer 216-844-3862
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Laura Hutchins 501-686-8511
Cancer Research Network Inc. *Recruiting*
Plantation, Florida, 33324
United States
Recruiting Charles Vogel 954-473-6776
Maine Center for Cancer Medicine and Blood Disorders - Scarborough *Recruiting*
Scarborough, Maine, 04074
United States
Recruiting Tracey Weisberg 207-885-7634
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Thomas Doyle 313-916-2778
Kaiser Permanente Medical Center - Vallejo *Recruiting*
Vallejo, California, 94589
United States
Recruiting Louis Fehrenbacher 707-651-2577
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0501
United States
Recruiting Elyse Lower 513-584-7661
Additional Information:
Study ID Numbers: CDR0000068841; ROCHE-1100,ROCHE-BO16216,CWRU-030118,GENENTECH-H2223g,ROCHE-B016216E
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022672
Other Stage 4 Breast Cancer Studies:
1. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer
2. Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
3. HER-2 Protein Vaccine in Treating Women With Breast Cancer
4. Erlotinib in Treating Women With Locally Advanced or Metastatic Breast Cancer
5. Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
Related Studies:
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Anastrozole With or Without Trastuzumab in Treating Postmenopausal Women With Metastatic Breast Cancer
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