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Alkylating agents

A for Ductal Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Windy Hill Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 - 10 weeks
Awards & highlights

Study Summary

The primary objective of this study is to compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion. Secondary objectives are to characterize the biologic and clinical effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram, histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.

Eligible Conditions
  • Ductal Carcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 - 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 - 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion
Secondary outcome measures
Biomarker measurement of Ki-67, TUNEL and G-actin
characterize clinical extent of disease on MRI and/or mammogram
characterize i.d. carboplatin pharmacokinetics
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: BExperimental Treatment1 Intervention
Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15
Group II: AExperimental Treatment1 Intervention
Carboplatin infused into DCIS-involved duct on Days 1 & 15
Group III: CPlacebo Group1 Intervention
Normal Saline infused into DCIS-involved duct Days 1 & 15

Find a Location

Who is running the clinical trial?

Windy Hill Medical, Inc.Lead Sponsor
Jane Doerr, RN, MSNStudy DirectorWindy Hill Medical, Inc.

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
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
2008. "Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00669747.
All > Dcis
~3 spots leftby Apr 2025
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