Preoperative Herceptin and Navelbine for Breast Cancer
1 other identifier
interventional
49
1 country
3
Brief Summary
The purpose of this study is to find out what effects the preoperative combination therapy of herceptin and navelbine have on HER-2 positive breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started May 2001
Shorter than P25 for phase_2 breast-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedJanuary 15, 2019
January 1, 2019
2 years
September 7, 2005
January 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the complete response rate after preoperative herceptin and navelbine in HER-2 positive breast cancer.
2 years
Secondary Outcomes (1)
To determine the safety of herceptin and navelbine in this patient population (either high risk or low risk).
2 years
Study Arms (2)
Lower Risk Regimen
EXPERIMENTALHigher Risk Regimen
EXPERIMENTALInterventions
Intravenously every week for 12 weeks (weeks 1-12) Intravenously every three weeks for 40 weeks (weeks 32-72)
Every 3 weeks for 12 weeks
Intravenously every 3 weeks for 12 weeks
Eligibility Criteria
You may qualify if:
- EGOG performance status of 0-1
- HER2 overexpressing (IHC 3+ or FISH +)
- Stage II or III breast cancer. Clinical T1N1M) and inflammatory (T4) breast cancer are eligible
- Patients with metastatic breast cancer (Stage IV) which is limited to supraclavicular and/or infraclavicular node positivity are eligible
- years of age or older
You may not qualify if:
- Prior therapy with herceptin, paclitaxel or other taxane, doxorubicin or other anthracycline-type chemotherapy, navelbine
- Pregnant or lactating women
- Uncontrolled infections, including AIDS
- History or symptoms diagnostic of systemic connective tissue or inflammatory disease
- Active or severe cardiovascular or pulmonary disease, including recent myocardial infarction or deep-venous thrombosis/pulmonary embolism, congestive heart failure, uncontrolled hypertension, or steroid-dependent asthma.
- Left ventricular ejection fraction \< 50%
- Peripheral neuropathy of any etiology that exceeds grade 1
- Prior history of malignancy treated without curative intent
- Uncontrolled diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Massachusetts General Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Winer, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 8, 2005
Study Start
May 1, 2001
Primary Completion
May 1, 2003
Study Completion
May 1, 2003
Last Updated
January 15, 2019
Record last verified: 2019-01