Afimoxifene for Ductal Breast Carcinoma In Situ

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ductal Breast Carcinoma In Situ+1 MoreAfimoxifene - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is testing two drugs to see how well they work in treating patients with estrogen-positive breast cancer.

Eligible Conditions
  • Ductal Breast Carcinoma In Situ
  • Estrogen Receptor Positive

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 1 month after surgery

Month 1
CD68, p16, and COX2 assessed by IHC
Estradiol and progesterone levels in breast tissue and plasma assessed by liquid chromatography/tandem mass spectrometry
Fraction of subjects with "no residual DCIS" in surgical sample assessed by core needle biopsy
Ki67 labeling assessed by standard immunohistochemistry
Oncotype DCIS-score assessed by RT-PCR
Pathologic complete response defined as absence of residual DCIS or residual DCIS responded completely to therapy
Plasma markers of systemic estrogenic effect (IGF-1, SHBG)
Plasma proteins involved in coagulation (factors VIII and IX, von Willebrand factor, and total protein S)
Symptoms assessed by BESS questionnaire
TAM and its metabolites levels in breast tissue and plasma

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm II (placebo, tamoxifen citrate)
1 of 2
Arm I (afimoxifene, placebo)
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Afimoxifene · Has Placebo Group · Phase 2

Arm I (afimoxifene, placebo)Experimental Group · 3 Interventions: Afimoxifene, Laboratory Biomarker Analysis, Placebo · Intervention Types: Drug, Other, Other
Arm II (placebo, tamoxifen citrate)ActiveComparator Group · 3 Interventions: Tamoxifen Citrate, Laboratory Biomarker Analysis, Placebo · Intervention Types: Drug, Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 month after surgery

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,448 Previous Clinical Trials
775,799 Total Patients Enrolled
3 Trials studying Ductal Breast Carcinoma In Situ
347 Patients Enrolled for Ductal Breast Carcinoma In Situ
BHR Pharma, LLCIndustry Sponsor
4 Previous Clinical Trials
1,507 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,753 Total Patients Enrolled
18 Trials studying Ductal Breast Carcinoma In Situ
2,887 Patients Enrolled for Ductal Breast Carcinoma In Situ
Seema Khan, MDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
80 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The use of tamoxifen is recommended in women with breast cancer who have not previously received chemotherapy.
You have total bilirubin within 1.5 x institutional upper limit of normal (ULN).