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View Clinical Trial (Medical Research Study)
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Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer - NCT00433511-02115B (Clinical Trial 162250)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy162250.aspx
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| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02115 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and
paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. 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 breast cancer by blocking blood flow to the tumor.
Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that
remain after surgery. It is not yet known whether doxorubicin, cyclophosphamide, and
paclitaxel are more effective with or without bevacizumab in treating breast cancer.
PURPOSE: This randomized phase III trial is studying doxorubicin, cyclophosphamide, and
paclitaxel to see how well they work with or without bevacizumab in treating patients with
lymph node-positive or high-risk, lymph node-negative breast cancer.
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| Study summary: |
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OBJECTIVES:
Primary
- Compare the disease-free survival (DFS) of patients with lymph node-positive or
high-risk, lymph node-negative breast cancer treated with adjuvant therapy comprising
doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with vs. without
bevacizumab.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Determine the toxicity of these regimens.
- Compare the efficacy of short-term (20-24 weeks) vs long-term (50-54 weeks)
bevacizumab, in terms of DFS, in these patients.
- Evaluate the association between outcomes (disease-free survival, overall survival and
toxicities) and genotype (derived from candidate single nucleotide polymorphisms and
genome wide evaluations).
- Compare quality of life patients treated with these regimens, in terms of physical
symptoms, physical functioning, psychological state and social functioning over an 18
month period.
- Determine the impact of theoretical biomarker information on patients' willingness to
accept the toxicities of bevacizumab for the estimated potential benefit.
OUTLINE: This is a randomized, partially double-blind, placebo-controlled, partially
open-label, multicenter study. Patients are stratified according to planned dose schedule of
doxorubicin hydrochloride and cyclophosphamide (every 3 weeks vs every 2 weeks). Patients
are further stratified according to estrogen receptor status (positive vs negative), lymph
node involvement (node-negative vs 1-3 positive node[s] vs ≥ 4 positive nodes), and
received/planned treatment (lumpectomy and whole breast radiation therapy vs lumpectomy and
accelerated partial-breast radiation therapy [before or after chemotherapy] vs mastectomy
without radiation therapy vs mastectomy [with local or regional]). Patients are randomized
to 1 of 3 treatment arms (20% of patients are randomized to Arm I, 40% to Arm II, and 40% to
Arm III).
- Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30
minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3
weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over
1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1.
Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.
- Arm II: Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and
bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4
courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm I and
bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab
repeats every 3 weeks for 4 courses.
- Arm III: Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I
and bevacizumab as in arm II. Treatment repeats every 2 or 3 weeks for 4 courses.
Beginning 3 weeks later, patients then receive paclitaxel as in arm I and bevacizumab
as in arm II. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4
courses. Beginning 2 months later, patients then receive open-label bevacizumab IV over
30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10
courses.
In all arms, treatment continues in the absence of disease progression or unacceptable
toxicity. Patients complete quality of life (QOL) questionnaires followed by telephone QOL
interviews at baseline and periodically.
After completion of study treatment, patients are followed periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 4,950 patients will be accrued for this study. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Significant risk of distant recurrence based on ≥ 1 of the following criteria:
- Axillary lymph node positive disease
- At least 1 sentinal or axillary lymph node (LN) positive on routine
histologic examination (must be demonstrated by more than
immunohistochemistry alone)
- Intramammary nodes considered equivalent to axillary nodes
- Axillary lymph node negative disease
- LN negative with estrogen receptor (ER)-negative tumor ≥ 1 cm
- LN negative with ER+ tumor ≥ 5 cm regardless of recurrence score
- LN negative with ER+ tumor ≥ 1 cm but < 5 cm with a recurrence score ≥
11
- Patients enrolled on ECOG-PACCT-1 clinical trial are eligible
- Has undergone definitive breast surgery within the past 29-84 days, including total
mastectomy and axillary dissection (modified radical mastectomy), total mastectomy
and sentinel node biopsy, lumpectomy and axillary dissection, or lumpectomy and
sentinel node biopsy
- Surgical margins must be histologically free of invasive breast cancer and
ductal carcinoma in situ
- Resection margins positive for lobular carcinoma in situ allowed
- Planned post-lumpectomy radiation therapy required, including any of the following:
- Whole breast radiation therapy after chemotherapy
- Accelerated partial breast radiation therapy after chemotherapy
- Accelerated partial breast radiation therapy prior to chemotherapy
- Planned post-mastectomy radiation therapy required for patients with a primary tumor
of ≥ 5 cm or involvement of ≥ 4 lymph nodes
- No HER2/neu positive breast cancer (i.e., 3+ by immunohistochemistry or fluorescent
in situ hybridization [FISH] ratio ≥ 2)
- No clinical evidence of inflammatory disease or fixed axillary nodes (N2) at
diagnosis
- May have synchronous bilateral breast cancer (diagnosed ≤ 1 month) if the higher TNM
stage tumor meets the eligibility criteria for this trial
- Hormone receptor status known
PATIENT CHARACTERISTICS:
- Male or female
- Pre- or post-menopausal
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 mg/dL
- AST ≤ 2 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 mg/dL
- Urine protein:creatinine ratio < 1.0
- PTT ≤ 1.5 times ULN
- LVEF normal by echocardiogram or MUGA
- No clinically significant cardiovascular or cerebrovascular disease, including any of
the following:
- Uncontrolled arrhythmia
- Controlled atrial fibrillation allowed
- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 160 mm Hg
or diastolic BP > 90 mm Hg
- Transient ischemic attack, stroke, or subarachnoid hemorrhage
- Ischemic bowel
- Myocardial infarction within the past 12 months
- Unstable angina within the past 12 months
- New York Heart Association class II-IV congestive heart failure within the past
12 months
- Peripheral vascular disease ≥ grade 2 within the past 12 months
- No bleeding diathesis, hereditary or acquired bleeding disorder, or coagulopathy
- No nonhealing wound or fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months
- No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor EL, Chinese
hamster ovary cell products, or other recombinant human antibodies
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 28 days since prior major surgery
- Nonoperative biopsy not considered major surgery
- More than 24 hours since prior placement of a vascular access device
- No prior cytotoxic chemotherapy or hormonal therapy for study cancer
- May have received prior (but no concurrent) tamoxifen or raloxifene for
chemoprevention
- No prior anthracycline, anthracenedione, or taxane for any condition
- Concurrent full-dose anticoagulation allowed provided the following criteria are met:
- INR in-range (usually between 2 and 3) on a stable dose of warfarin or low
molecular weight heparin
- No active bleeding or pathological conditions that carry a high risk of bleeding
(e.g., varices)
- Concurrrent prophylactic anticoagulants to maintain patency of a vascular access
device allowed
- No concurrent cardioprotectant drugs |
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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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September 23, 2009 |
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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