Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer
Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer
3 other identifiers
interventional
226
1 country
1
Brief Summary
This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes. 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 tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with more than one chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2005
CompletedFirst Posted
Study publicly available on registry
July 13, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
April 28, 2011
CompletedMay 15, 2014
December 1, 2012
3.8 years
July 12, 2005
April 4, 2011
April 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Congestive Heart Failure Rate
Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.
assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry
Secondary Outcomes (2)
Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC)
assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment
Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab
assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment
Study Arms (2)
Arm I (combination chemotherapy, 18 courses of bevacizumab)
EXPERIMENTALSee detailed description.
Arm II (combination chemotherapy, 22 courses of bevacizumab)
ACTIVE COMPARATORSee detailed description.
Interventions
Given IV
Given IV
Given IV
Given IV
Given SC
Given SC
Undergo radiation therapy
Given orally
Receive aromatase inhibition therapy
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the breast with involvement of at least one axillary or internal mammary lymph node on routine histologic examination with hematoxylin and eosin staining; NOTE: patients with axillary or internal mammary node involvement only demonstrated by immunohistochemistry are not eligible
- Patients must have completed definitive breast surgery 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; NOTE: axillary dissection is strongly encouraged in patients with lymph node involvement identified on sentinel node biopsy
- Margins of lumpectomy or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS); patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible
- (ARM A ONLY) Interval between last surgery for breast cancer (lumpectomy, mastectomy, sentinel node biopsy, axillary dissection or re-excision of lumpectomy margins) and D1 must be \> 28 days and =\< 84 days
- ECOG performance status of 0-2
- Absolute neutrophil count \>= 1000/mm\^3
- Platelet count \>= 100,000/mm\^3
- Total bilirubin =\< 1.5 mg/dL
- AST =\< 2 upper limit of normal
- Serum creatinine =\< 1.5 mg/dL
- Urine protein: creatinine ratio \< 1.0
- PT INR =\< 1.5
- PTT =\< 1.5 x normal
- LVEF \>= institutional limits of normal by MUGA or ECHO
- Prior to registration the investigator must specify if radiation is planned; patients who have undergone a lumpectomy must receive radiation; post-mastectomy radiation is at the investigator's discretion
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- Eastern Cooperative Oncology Group (ECOG) Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Kathy Miller
Eastern Cooperative Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2005
First Posted
July 13, 2005
Study Start
October 1, 2005
Primary Completion
August 1, 2009
Study Completion
September 1, 2009
Last Updated
May 15, 2014
Results First Posted
April 28, 2011
Record last verified: 2012-12