Clinical trial · Interventional
Safety Study of Bevacizumab to Treat Women With a History of Breast Cancer and Suffering From Upper Extremity Lymphedema
Phase I Study Evaluating the Safety of Bevacizumab in Women With a History of Breast Cancer Suffering From Moderate to Severe Upper Extremity Lymphedema
NCT00318513CI-TRIAL-00000335unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the safety and side effects of bevacizumab in subjects with lymphedema who will initially receive bevacizumab alone and then in combination with standard manual lymphatic drainage (MLD) and combined decongestive therapy (CDT). This study will help to determine the dose of bevacizumab to be used in future studies of subjects with lymphedema.
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 |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 0 Years
Show eligibility criteria text
Inclusion Criteria: * Women with a history of breast cancer status post (s/p) prior surgical resection (i.e., either lumpectomy and radiation, modified radical mastectomy or radical mastectomy) with lymphedema defined as a difference in limb volume of at least 500 ml by perometric assessment * Lymphedema may be newly diagnosed or previously treated as long as it is Stage I (pitting) or II (fibrosis) at the time of study entry. * No known evidence of recurrent or active metastatic breast cancer * No prior chemotherapy within 6 months of study entry and has recovered to grade 1 or less from the toxicity of all prior chemotherapy or radiation therapy (with the exception of alopecia); ongoing anti-estrogen therapy for post-menopausal survivors is permissible. * Normal end organ function defined as: serum creatinine \< 1.5 mg/dl or a calculated creatinine clearance \> 50 ml/min; SGOT and SGPT \< 2.5 X upper limit of normal (ULN); total bilirubin \< 1.5 X ULN; absolute neutrophil count (ANC) \> 1,500 cells/µl; hemoglobin \> 10 g/dl (without transfusions); platelet count \> 100,000/µl; serum albumin within normal limits (WNL). Exclusion Criteria: * Stage III (lymphostatic elephantiasis) lymphedema * Clinical evidence of bilateral lymphedema. Those patients who have undergone bilateral breast cancer surgery or prophylactic mastectomy on the non-cancerous breast will be excluded. * Any prior history of deep venous thrombosis (DVT) or pulmonary embolus (with the exception of prior line-related thrombotic events) or myocardial infarction (MI), cerebrovascular accident (CVA) or any other arterial thromboembolic event (i.e., transient ischemic attack \[TIA\], reversible ischemic neurologic deficit \[RIND\], history of angina pectoris, clinically significant peripheral vascular disease with claudication, etc.) * Patients with problems with wound healing (e.g., diabetic ulcers), gastrointestinal fistula * Patients receiving therapeutic anti-coagulation including full dose aspirin or non-steroidal anti-inflammatory agents known to inhibit platelet function (low dose coumadin for port prophylaxis and low dose aspirin are allowed) * Untreated hypertension with a baseline systolic blood pressure (SBP) of \> 150 mmHg or a diastolic blood pressure (DBP) \>100 mmHg will be excluded (stable treated hypertension with values less than those noted will be eligible). * A history of infectious complications of the involved arm or those with any contraindication to MLD + CB \[e.g., congestive heart failure (CHF), DVT, acute or chronic renal failure\] will be excluded. * Women with a history of CHF \[New York Heart Association (NYHA) Class II or greater\] will be excluded. * Pregnant or breast-feeding * Unwilling to use an appropriate form of barrier contraception for the duration of the study and for three months following the last dose of bevacizumab * Those patients who are actively undergoing MLD and/or CB at the time of study entry and for up to 4 weeks prior to entry * Unable to provide written informed consent or to comply with study procedures * Baseline urine protein : creatinine ratio \> 1.0 * Known evidence of a bleeding diathesis or coagulopathy
References
Publications (45)
- BACKGROUNDVelanovich V, Szymanski W. Quality of life of breast cancer patients with lymphedema. Am J Surg. 1999 Mar;177(3):184-7; discussion 188. doi: 10.1016/s0002-9610(99)00008-2. PMID 10219851
- BACKGROUNDYeoh EK, Denham JW, Davies SA, Spittle MF. Primary breast cancer. Complications of axillary management. Acta Radiol Oncol. 1986 Mar-Apr;25(2):105-8. doi: 10.3109/02841868609136386. PMID 3012953
- BACKGROUNDBrennan MJ, DePompolo RW, Garden FH. Focused review: postmastectomy lymphedema. Arch Phys Med Rehabil. 1996 Mar;77(3 Suppl):S74-80. doi: 10.1016/s0003-9993(96)90248-8. PMID 8599548
- BACKGROUNDKobayashi MR, Miller TA. Lymphedema. Clin Plast Surg. 1987 Apr;14(2):303-13. PMID 3555946
- BACKGROUNDMortimer PS. The pathophysiology of lymphedema. Cancer. 1998 Dec 15;83(12 Suppl American):2798-802. doi: 10.1002/(sici)1097-0142(19981215)83:12b+3.3.co;2-5. PMID 9874400
- BACKGROUNDBates DO, Levick JR, Mortimer PS. Starling pressures in the human arm and their alteration in postmastectomy oedema. J Physiol. 1994 Jun 1;477(Pt 2):355-63. doi: 10.1113/jphysiol.1994.sp020197. PMID 7932226
- BACKGROUNDSvensson WE, Mortimer PS, Tohno E, Cosgrove DO. Increased arterial inflow demonstrated by Doppler ultrasound in arm swelling following breast cancer treatment. Eur J Cancer. 1994;30A(5):661-4. doi: 10.1016/0959-8049(94)90540-1. PMID 8080683
- BACKGROUNDStanton AW, Holroyd B, Northfield JW, Levick JR, Mortimer PS. Forearm blood flow measured by venous occlusion plethysmography in healthy subjects and in women with postmastectomy oedema. Vasc Med. 1998;3(1):3-8. doi: 10.1177/1358836X9800300102.