Clinical trial · Interventional
Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel + Bevacizumab
- interventionNames
- Drug: bevacizumab
- Drug: Paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Progression-Free Survival
- timeFrame
- Assessed every 3 months for 2 years, then every 6 months for 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 * 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 * 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
References
Publications (6)
- BACKGROUNDGray R, Giantonio BJ, O'Dwyer PJ, et al.: The safety of adding angiogenesis inhibition into treatment for colorectal, breast, and lung cancer: the Eastern Cooperative Oncology Group's (ECOG) experience with bevacizumab (anti-VEGF). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-825, 2003.
- RESULTSchneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD; ECOG 2100. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol. 2008 Oct 1;26(28):4672-8. doi: 10.1200/JCO.2008.16.1612. PMID 18824714
- RESULTMiller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666-76. doi: 10.1056/NEJMoa072113. PMID 18160686
- RESULTCella D, Wang M, Wagner L, Miller K. Survival-adjusted health-related quality of life (HRQL) among patients with metastatic breast cancer receiving paclitaxel plus bevacizumab versus paclitaxel alone: results from Eastern Cooperative Oncology Group Study 2100 (E2100). Breast Cancer Res Treat. 2011 Dec;130(3):855-61. doi: 10.1007/s10549-011-1725-6. Epub 2011 Aug 27. PMID 21874312
- RESULTMiller KD, Wang M, Gralow J, et al.: A randomized phase III trial of paclitaxel versus paclitaxel plus bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer: a trial coordinated by the Eastern Cooperative Oncology Group (E2100). [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-3, 2005.
- RESULTMiller KD. E2100: a phase III trial of paclitaxel versus paclitaxel/bevacizumab for metastatic breast cancer. Clin Breast Cancer. 2003 Feb;3(6):421-2. doi: 10.3816/CBC.2003.n.007. No abstract available.