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Alkylating agents

Carboplatin for Breast Cancer

Phase 2
Waitlist Available
Led By Kari Wisinski, MD
Research Sponsored by University of Wisconsin, Madison
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 up to 2 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat triple negative breast cancer in the neoadjuvant setting.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate
Secondary outcome measures
Delays of Administered Chemotherapy
Number of Cycles of Chemotherapy Administered
Number of Treatment-related Toxicities Experienced by Participants
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neoadjuvant ChemotherapyExperimental Treatment6 Interventions
Regimen A (cycles 1-4): Paclitaxel 80 mg/m2; administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Carboplatin AUC=2 (dose calculation by determining creatine clearance with Cockroft Gault using adjusted body weight); administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Regimen B (cycles 5-8): Doxorubicin 60 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Cyclophosphamide 600 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Pegfilgrastim (for use on Doxorubicin/Cyclophosphamide cycles only), filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks) There is a one week break between the end of cycle 4 and the beginning of cycle 5. Regimen C: Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Pegfilgrastim
FDA approved
Filgrastim
FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,942 Total Patients Enrolled
35 Trials studying Breast Cancer
38,490 Patients Enrolled for Breast Cancer
Kari Wisinski, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
6 Previous Clinical Trials
140 Total Patients Enrolled
1 Trials studying Breast Cancer
6 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer
2017. "Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03301350.
~4 spots leftby Apr 2025
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