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Bevacizumab with Or Without Cyclophosphamide and Methotrexate: a Pilot Study in Women with Operable Breast Cancer - Article


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Methotrexate

Rheumatrex; Trexall



Clinical Trial: Bevacizumab with Or Without Cyclophosphamide and Methotrexate: a Pilot Study in Women with Operable Breast Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Dana-Farber Cancer Institute
Genentech
Beth Israel Deaconess Medical Center
Information provided by: Dana-Farber Cancer Institute

Purpose

The purpose of this study is to find out what effects (good and bad) bevacizumab, with or without low-dose continuous chemotherapy, have on patients with residual breast cancer following preoperative chemotherapy.
Condition Intervention Phase
Breast Cancer
 Drug: Bevacizumab
 Drug: Cyclophosphamide
 Drug: Methotrexate
Phase II

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Anti-Angiogenesis Treatment After Preoperable Chemotherapy: a Pilot Study in Women with Operable Breast Cancer

Further Study Details: 
Primary Outcomes: To determine the feasibility of bevacizumab, with or without metronomic chemotherapy, in treating patients with breast cancer; to determine the side-effects of bevacizumab alone versus when used in conjunction with metronomic chemotherapy
Secondary Outcomes: Monitor changes in left ventricular ejection fraction (LVEF); rate of recurrence, either local or distant; look at blood markers to determine how treatment is working; explore predictors of tumor recurrence after preoperative chemotherapy and during bevacizumab-based adjuvant therapy; characterize safety of radiation therapy immediately followed by bevacizumab or bevacizumab plus metronomic chemotherapy
Expected Total Enrollment:  100

Study start: June 2005

- This study is broken into 2 groups (A and B) and is currently enrolling for Group A only. Group A will consist of 60 patients and once it is full, Group B will start enrolling. Group B will consist of 40 patients.

  • Patients in Group A are treated with bevacizumab every 3 weeks for 12 months. Prior to each bevacizumab administration, a physical exam, blood tests and urine test will be performed.
  • Patients in Group B are treated with bevacizumab (once every 3 weeks), cyclophosphamide (once daily), and methotrexate (twice daily for the first 2 days of each week) for 6 months. Then for the subsequent 6 months, with bevacizumab (once every 3 weeks) only. Prior to bevacizumab administration, a physical exam, blood tests and urine test will be performed.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging
  • Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.
  • Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.
  • For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.
  • Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.
  • LVEF > institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.
  • ECOG performance status 0-1

Exclusion Criteria:

  • Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment
  • Patients with metastatic disease are ineligible.
  • Known HIV infection
  • Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding
  • Uncontrolled intercurrent illness
  • Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment
  • History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab
  • Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded
  • History of bleeding diathesis or coagulopathy
  • History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)
  • Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer
  • Patients with large or rapidly accumulating pleural or abdominal effusions
  • Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR
  • Chronic therapy with full dose aspirin (< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed
  • Patients may not receive other investigational agents while on study

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00121134

Nicole Brooke      617-632-6767 

Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
Nicole Brooke  617-632-6767 
Harold Burstein, MD, PhD,  Principal Investigator
Eric Winer, MD,  Sub-Investigator
Craig Bunnell, MD,  Sub-Investigator
Wendy Chen, MD,  Sub-Investigator
Susana Campos, MD,  Sub-Investigator
Ursula Matulonis, MD,  Sub-Investigator
Judy Garber, MD,  Sub-Investigator
Lyndsay Harris, MD,  Sub-Investigator
Lawrence N Shulman, MD,  Sub-Investigator
Jennifer Ligibel, MD,  Sub-Investigator
Ian Krop, MD, PhD,  Sub-Investigator
Ann Partridge, MD,  Sub-Investigator
Daniel Silver, MD,  Sub-Investigator
Karen Anderson, MD, PhD,  Sub-Investigator
Leroy Parker, MD,  Sub-Investigator
Rochelle Scheib, MD,  Sub-Investigator

      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02115,  United States; Recruiting
Steven E. Come, MD  617-667-4599 
Steven E. Come, MD,  Principal Investigator
Gerberg Wulf, MD,  Sub-Investigator
Nadine Tung, MD,  Sub-Investigator
Susan Schumer, MD,  Sub-Investigator
Roger Lange, MD,  Sub-Investigator
Lowell Schnipper, MD,  Sub-Investigator

Study chairs or principal investigators

Harold J Burstein, MD, PhD,  Principal Investigator,  Dana-Farber Cancer Institute   

More Information

Study ID Numbers:  05-055
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 20, 2005
ClinicalTrials.gov Identifier:  NCT00121134
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26

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Page Updated: October 1, 2005
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