Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00028990 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 15, 2023
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known whether paclitaxel works better with or without bevacizumab in treating breast cancer.
PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: bevacizumab Drug: Paclitaxel | Phase 3 |
OBJECTIVES:
- Compare the time to treatment failure in patients with locally recurrent or metastatic breast cancer treated with paclitaxel with or without bevacizumab.
- Compare the objective response rate, duration of response, overall survival, and time to progression in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease-free interval (no more than 24 months vs more than 24 months), number of metastatic sites (less than 3 vs 3 or more), treatment with prior adjuvant chemotherapy (yes vs no), and estrogen receptor status (positive vs negative vs unknown). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 followed by bevacizumab IV over 30-90 minutes on days 1 and 15.
- Arm II: Patients receive paclitaxel as in arm I. In both arms, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and on day 1 of weeks 17 and 33.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 316-650 patients (158-325 per treatment arm) will be accrued for this study within 31 months.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 722 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer |
| Actual Study Start Date : | January 29, 2002 |
| Actual Primary Completion Date : | November 2006 |
| Actual Study Completion Date : | May 2009 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Paclitaxel + Bevacizumab |
Drug: bevacizumab
10 mg/kg following paclitaxel treatment on weeks 1 and 3 of every 4-week cycle
Other Name: Avastin Drug: Paclitaxel 90 mg/m2 IV infusion over 1 hour every week for 3 weeks followed by 1 week rest |
| Active Comparator: Paclitaxel |
Drug: Paclitaxel
90 mg/m2 IV infusion over 1 hour every week for 3 weeks followed by 1 week rest |
- Progression-Free Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ]
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Locally recurrent disease that is not amenable to surgical resection with curative intent OR
- Metastatic disease
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No HER-2-overexpressing (3+) breast cancer unless previously treated with trastuzumab (Herceptin)
- Unknown HER-2 status allowed provided herceptin-based therapy inappropriate or not indicated
- No prior or radiologic evidence of CNS metastases, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI
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Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No prior bleeding diathesis
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN for known liver involvement)
- PT/PTT no greater than 1.5 times normal
- INR no greater than 1.5 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- No proteinuria by dipstick urinalysis
- Trace proteinuria allowed
- Proteinuria less than 500 mg by 24-hour urine collection if proteinuria at least 1+ by urinalysis
Cardiovascular:
- No clinically significant cardiovascular disease
- No myocardial infarction within the past 12 months
- No unstable angina
- No prior deep vein thrombosis
- No grade 2 or greater peripheral vascular disease
- No uncontrolled congestive heart failure
- No uncontrolled hypertension (systolic blood pressure greater than 170 mmHg and diastolic blood pressure greater than 95 mm Hg)
- No prior cerebrovascular accident
Pulmonary:
- No prior pulmonary embolism
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective non-hormonal contraception
- No history of seizures
- No non-healing wound or fracture
- No hypersensitivity to paclitaxel, Cremophor EL, Chinese hamster ovary cell products, or other recombinant human antibodies
- No active infection requiring parenteral antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- No prior chemotherapy for locally recurrent or metastatic breast cancer
- At least 12 months since prior adjuvant or neoadjuvant taxane therapy
- At least 3 weeks since prior adjuvant chemotherapy
Endocrine therapy:
- At least 3 weeks since prior hormonal therapy for locally recurrent or metastatic breast cancer
Radiotherapy:
- At least 3 weeks since prior radiotherapy
- No prior radiotherapy to only site of disease
- No concurrent local radiotherapy for pain control or life-threatening situations (e.g, superior vena cava syndrome, spinal cord compression, or CNS metastases)
Surgery:
- At least 4 weeks since prior major surgical procedure except placement of vascular access device or breast biopsy
- At least 7 days since prior minor surgical procedure, including placement of an access device or fine needle aspiration
Other:
- At least 10 days since prior anticoagulant therapy (low-dose anticoagulant therapy to maintain patency of a vascular access device allowed)
- At least 10 days since prior and no concurrent daily aspirin (more than 325 mg/day) or other non-steroidal anti-inflammatory medication known to inhibit platelet function
- No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028990
Show 30 study locations
| Study Chair: | Kathy Miller, MD | Indiana University Melvin and Bren Simon Cancer Center | |
| OverallOfficial: | Robin Zon, MD | Elkhart General Hospital | |
| Study Chair: | Edith A. Perez, MD | Mayo Clinic | |
| Study Chair: | Tamara N. Shenkier, MD | British Columbia Cancer Agency | |
| Study Chair: | Melody A. Cobleigh, MD | Rush University Medical Center |
Other Publications:
| Responsible Party: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00028990 |
| Other Study ID Numbers: |
CDR0000069156 E2100 NCCTG-E2100 CAN-NCIC-MAC3 NSABP-E2100 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | June 15, 2023 |
| Last Verified: | June 2023 |
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stage IV breast cancer recurrent breast cancer male breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Bevacizumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |