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Alkylating agents
Docetaxel with Cytoxan for Breast Cancer
Phase 2
Waitlist Available
Led By Elisavet Paplomata, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of definitive surgery
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Summary
The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of definitive surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of definitive surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathologic Response to Pre-operative Docetaxel and Cytoxan (TC)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Docetaxel with CytoxanExperimental Treatment2 Interventions
Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,813 Total Patients Enrolled
27 Trials studying Breast Cancer
7,431 Patients Enrolled for Breast Cancer
SanofiIndustry Sponsor
2,198 Previous Clinical Trials
4,035,514 Total Patients Enrolled
51 Trials studying Breast Cancer
24,206 Patients Enrolled for Breast Cancer
Elisavet Paplomata, MDPrincipal InvestigatorEmory University Winship Cancer Institute
3 Previous Clinical Trials
126 Total Patients Enrolled
3 Trials studying Breast Cancer
126 Patients Enrolled for Breast Cancer
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