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View Clinical Trial (Medical Research Study)
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Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer - NCT00601900-37403 (Clinical Trial 200067)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy200067.aspx
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| City: |
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Chattanooga |
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State:
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TN |
| Zip Code: |
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37403 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor
cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.
Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of
tumor cells by blocking blood flow to the tumor. It is not yet known whether giving hormone
therapy is more effective with or without bevacizumab in treating advanced breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen or letrozole together
with bevacizumab to see how well it works compared with tamoxifen or letrozole alone in
treating women with stage III or stage IV breast cancer.
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| Study summary: |
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OBJECTIVES:
Primary
- To compare the progression-free survival of letrozole therapy plus placebo with the
combination of letrozole therapy plus bevacizumab as first-line treatment in women with
estrogen- and/or progesterone-receptor-positive stage IIIB-IV breast cancer.
Secondary
- To compare the proportion of patients receiving letrozole plus placebo and receiving
letrozole plus bevacizumab who remain progression-free at 6 and 12 months.
- To compare the incidence of objective response (complete response [CR] + partial
response [PR]), in patients receiving letrozole with and without bevacizumab, as
determined by RECIST criteria, excluding patients with non-measurable disease.
- To compare the incidence of clinical benefit (CR + PR + stable disease ≥ 6 months) in
patients receiving letrozole with and without bevacizumab.
- To compare the duration of objective response in patients receiving letrozole with and
without bevacizumab.
- To compare the time to treatment failure, defined as the interval from randomization
until progression, toxicity, withdrawn consent, or going onto nonprotocol therapy, in
patients receiving letrozole with and without bevacizumab.
- To compare the overall survival of patients receiving letrozole with and without
bevacizumab, including the probability of survival until 36 months.
- To compare toxicity levels between placebo and bevacizumab in both the letrozole
treated patients and in the tamoxifen-treated patients.
- To compare progression-free survival and overall survival of all patients receiving
endocrine therapy with and without bevacizumab (by combining both letrozole and
tamoxifen patient subgroups).
OUTLINE: This is a multicenter study. Patients are stratified according to planned endocrine
therapy (letrozole vs tamoxifen), disease measurability (no vs yes), and disease-free
interval from initial diagnosis to first progression (≤ 24 months vs > 24 months). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral endocrine therapy (tamoxifen citrate or letrozole) once
daily and bevacizumab IV every 21 days. Treatment repeats every 21 days in the absence
of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral endocrine therapy (tamoxifen citrate or letrozole) once
daily and a placebo IV every 21 days. Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 6 months for the first 2
years, then annually for up to 3 years. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologic confirmation of invasive cancer of the female breast in either the primary
or metastatic setting
- Stage IIIB disease not amenable to local therapy or stage IV disease
- Must have measurable or nonmeasurable disease by RECIST criteria, with radiologic
scans (CT scan of the chest/abdomen)
- Measurable disease is defined as lesions that can be accurately measured in at
least one dimension (longest diameter to be recorded) as ≥ 2.0 cm with
conventional techniques or as ≥ 1.0 cm with spiral CT scan
- Nonmeasurable disease is defined as all other lesions, including small lesions
(longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral
CT scan) and truly nonmeasurable lesions, including any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Baseline bone scans required for all patients for determination of metastatic bone
disease
- CT scan with bone windows required only for patients with bone metastases as the
only site of disease
- No known CNS metastases or leptomeningeal disease (screening with brain imaging is
not required for asymptomatic patients)
- Hormone receptor status: tumors (from either primary or metastatic sites) must
express estrogen receptor (ER) and/or progesterone receptor (PgR) in ≥ 1% of cells
PATIENT CHARACTERISTICS:
- Menopausal status: pre- or postmenopausal, meeting 1 of the following criteria:
- Age ≥ 55 years and one year or more of amenorrhea
- Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20
pg/ml
- Age < 55 with prior hysterectomy but intact ovaries, with an estradiol assay <
20 pg/ml
- Surgical menopause with bilateral oophorectomy
- Ovarian suppression on a luteinizing hormone-releasing hormone agonist
(goserelin acetate or leuprolide acetate)
- Premenopausal women must undergo ovarian suppression prior to beginning
protocol therapy
- Ovarian radiation is not permitted for induction of ovarian
suppression
- ECOG (Zubrod) performance status 0-1
- Life expectancy ≥ 12 weeks
- Granulocytes ≥ 1,000/μl
- Platelet count ≥ 100,000/μl
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) unless due to Gilbert's syndrome
- Transaminases (ALT, AST) ≤ 2.5 times ULN
- INR ≤ 1.6 unless on full dose warfarin
- Urinalysis ≤ 1+ protein
- Proteinuria ≥ 2 + at baseline must demonstrate < 1 g of protein/24 hr or
protein:creatinine ratio < 1 on 24-hour urine collection
- No "currently active" second malignancy other than nonmelanoma skin cancers
- Patients are not considered to have a "currently active" malignancy if they have
completed therapy and are considered by their physician to be at less than 30%
risk of relapse
- Taxane-related neurotoxicity must have resolved to sensory grade < 2
- No motor neuropathy of any grade
- No significant traumatic injury within 28 days prior to study registration
- No history of abdominal fistula, or intra-abdominal abscess within the past 6 months
- No history of GI perforation within the past 12 months
- No history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI
bleeding) within the past 6 months
- No clinically significant cardiovascular disease, including any of the following:
- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg
and/or diastolic BP > 90 mm Hg on antihypertensive medications
- Prior history of hypertensive crisis or hypertensive encephalopathy
- Myocardial infarction or unstable angina within past 6 months
- New York Heart Association class II-IV congestive heart failure
- Symptomatic peripheral vascular disease
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Significant arterial thrombotic events
- No history of stroke or transient ischemic attack within the past 6 months
- History of seizures must be well controlled with standard medication
- No known allergies to imidazole drugs, (e.g., clotrimazole, ketoconazole, miconazole,
econazole, sulconazole, ticonazole, or terconazole) or compounds structurally similar
to bevacizumab (for patients treated with aromatase inhibitors)
- No known allergies to selective estrogen receptor modulators (e.g., tamoxifen,
raloxifene, or toremifene) or compounds structurally similar to bevacizumab (for
patients treated with tamoxifen)
- No serious, non-healing wound, ulcer, or bone fracture
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- No prior endocrine therapy in the metastatic setting unless tamoxifen or an aromatase
inhibitor was initiated within 4 weeks prior to registration
- If prior endocrine therapy was initiated within the past 4 weeks, the patients
should remain on that chosen hormonal therapy (tamoxifen or aromatase inhibitor)
as the study therapy
- Patients who began therapy with anastrozole or exemestane must switch to
letrozole
- Prior endocrine therapy in the adjuvant setting allowed
- Prior treatment with ovarian suppression is allowed in either the adjuvant or
metastatic setting
- If medical ovarian suppression is being administered it can be initiated any
time prior to or at the start of protocol therapy, and continued throughout the
duration of the trial
- At least 28 days since surgical castration with bilateral oophorectomy
- At least two weeks prior radiotherapy and all toxicities resolved
- At least 12 months since the completion of prior adjuvant or neoadjuvant chemotherapy
and all toxicities must have resolved
- No prior anti-VEGF or VEGFR tyrosine kinase inhibitor therapy
- No prior chemotherapy for metastatic disease
- More than 28 days since prior major surgical procedure or open biopsy and fully
recovered from any such procedure
- No core biopsy or other minor surgical procedure (except placement of a vascular
access device) within 7 days prior to study registration
- Prior palliative irradiation of a symptomatic lesion, or one that may produce
disability (e.g., unstable femur) prior to study initiation, provided other
measurable or non-measurable disease is present, is allowed
- Palliative radiotherapy may not be administered during protocol therapy
- Must not have anticipation of need for major surgical procedure during the course of
the study
- Concurrent full dose anticoagulation therapy is allowed for the treatment of prior
conditions such as venous thromboses or atrial fibrillation, but not for the
treatment of prior arterial thrombotic events
- Patients on full dose anticoagulants must be on a stable dose of warfarin and
have an in-range INR (usually between 2 and 3) or be on a stable dose of low
molecular weight heparin
- Concurrent antiplatelet agents, daily prophylactic aspirin, or anticoagulation for
atrial fibrillation allowed
- Concurrent treatment with bisphosphonates is allowed and recommended
- No concurrent hormones or other chemotherapeutic agents except for steroids given for
adrenal failure or chronic non-cancer related diseases, hormones administered for
non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of
dexamethasone as an antiemetic in solid tumor protocols |
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| Study is available at: |
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Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga, TN 37403
United States
Primary Contact:
Clinical Trials Office - Erlanger Cancer Center
Phone: 423-778-6947 |
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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.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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