Trial · NCT02993159

Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast

NCT02993159, Phase 2, Completed, Northwestern University; results first posted 2024-12-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast. Trials, record NCT02993159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02993159

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast
NCT number: NCT02993159
Status: Completed
Phases: Phase 2
Enrollment: 100 participants, actual
Lead sponsor: Northwestern University
Conditions: Ductal Breast Carcinoma In Situ, Estrogen Receptor Positive
Interventions: Afimoxifene, Laboratory Biomarker Analysis, Placebo, Placebo, Tamoxifen Citrate
First posted: 2016-12-15
Last updated: 2024-12-18
Results first posted: 2024-12-18

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Ki-67 Labeling Index	baseline to up to 10 weeks	Change in the Ki-67 labelling index of DCIS lesions evaluated using immunohistochemistry
Secondary	Change in Oncotype DCIS-Score	baseline to up to 10 weeks	Change in Exact Sciences Oncotype Diagnosis Breast Ductal Carcinoma in Situ Score (Oncotype DCIS-Score), a clinical validated clinically validated, commercially available genomic test for patients with DCIS. Oncotype DCIS-Score Range is 0-100. A negative change in scores indicates a lower risk of recurrence (better outcome).
Secondary	Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites	up to 10 weeks	Post-therapy concentrations of 4-OHT and endoxifen in breast tissue samples
Secondary	Post-therapy Plasma Levels of Tamoxifen and Its Metabolites	up to 10 weeks	Post-therapy concentrations of 4-OHT and endoxifen in plasma samples
Secondary	Ki-67 Labelling Index in the Terminal Duct Lobular Units (TDLUs)	baseline to up to 10 weeks	Mean change in Ki-67 labelling index in the terminal duct lobular units (TDLUs)
Secondary	Change in Plasma Proteins Involved in Coagulation	baseline to up to 10 weeks	Mean change in percentage of plasma proteins involved in coagulation: Factor VIII, Factor IX, von Willebrand Factor, and total protein S
Secondary	Change in Plasma Markers of Systemic Estrogenic Effect (SHBG)	baseline to up to 10 weeks	Mean change in plasma markers of systemic estrogenic effect: SHBG.
Secondary	Change in Plasma Markers of Systemic Estrogenic Effect (IGF-1)	baseline to up to 10 weeks	Mean change in plasma markers of systemic estrogenic effect: IGF-1
Secondary	Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire and Skin Reactions to 4-OHT Gel.	baseline to up to 10 weeks	Mean change in symptoms as captured using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, scores range from 0 (Not at All) to 4 (Extremely) when asked about experiencing symptoms. A positive change in scores indicates an increase in symptoms experienced and a negative change in scores indicates a decrease in symptoms experienced

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Ki-67 Labeling Index	baseline to up to 10 weeks	Participants with DCIS tissue samples at baseline and post-therapy	percent positive cells	MEAN
SECONDARY	Change in Oncotype DCIS-Score	baseline to up to 10 weeks	Participants with Oncotype-DCIS score at baseline and post-therapy	score on a scale	MEAN
SECONDARY	Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites	up to 10 weeks	Participants with post-therapy tissue samples	ng/g	MEDIAN
SECONDARY	Post-therapy Plasma Levels of Tamoxifen and Its Metabolites	up to 10 weeks	Participants with post-therapy plasma samples	ng/ml	MEDIAN
SECONDARY	Ki-67 Labelling Index in the Terminal Duct Lobular Units (TDLUs)	baseline to up to 10 weeks	Participants with terminal duct lobular units (TDLUs) at baseline and post-therapy	percent positive	MEAN
SECONDARY	Change in Plasma Proteins Involved in Coagulation	baseline to up to 10 weeks	Participants with plasma samples at baseline and post-therapy	percent	MEAN
SECONDARY	Change in Plasma Markers of Systemic Estrogenic Effect (SHBG)	baseline to up to 10 weeks	Participants with plasma samples at baseline and post-therapy	nmol/l	MEAN
SECONDARY	Change in Plasma Markers of Systemic Estrogenic Effect (IGF-1)	baseline to up to 10 weeks	Participants with plasma samples at baseline and post-therapy	ng/ml	MEAN
SECONDARY	Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire and Skin Reactions to 4-OHT Gel.	baseline to up to 10 weeks	Participants with BESS scores at baseline and post-therapy	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Ki-67 Labeling Index	Arm I (4-OHT Topical Gel, Placebo)		-1.0	95% Confidence Interval -2.4 to 0.52	percent positive cells
Change in Ki-67 Labeling Index	Arm II (Placebo, Oral Tamoxifen)		-4.8	95% Confidence Interval -6.6 to -3.1	percent positive cells
Change in Oncotype DCIS-Score	Arm I (4-OHT Topical Gel, Placebo)		-1.8	95% Confidence Interval -5.8 to 2.3	score on a scale
Change in Oncotype DCIS-Score	Arm II (Placebo, Oral Tamoxifen)		-16	95% Confidence Interval -22 to -9.4	score on a scale
Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites	Arm I (4-OHT Topical Gel, Placebo)	4-OHT, Superficial tissue sample	4.2	Inter-Quartile Range 1.5 to 17.8	ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites	Arm II (Placebo, Oral Tamoxifen)	4-OHT, Superficial tissue sample	6.0	Inter-Quartile Range 3.9 to 8.5	ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites	Arm I (4-OHT Topical Gel, Placebo)	4-OHT, Deep tissue sample	3.8	Inter-Quartile Range 1.3 to 7.9	ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites	Arm II (Placebo, Oral Tamoxifen)	4-OHT, Deep tissue sample	5.7	Inter-Quartile Range 4.0 to 7.9	ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites	Arm I (4-OHT Topical Gel, Placebo)	Endoxifen, Superficial tissue sample	0.2	Inter-Quartile Range 0.2 to 0.3	ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites	Arm II (Placebo, Oral Tamoxifen)	Endoxifen, Superficial tissue sample	16	Inter-Quartile Range 9.5 to 20.7	ng/g

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (4-OHT Topical Gel, Placebo)	47
Overall Study	STARTED	Arm II (Placebo, Oral Tamoxifen)	53
Overall Study	COMPLETED	Arm I (4-OHT Topical Gel, Placebo)	42
Overall Study	COMPLETED	Arm II (Placebo, Oral Tamoxifen)	48
Overall Study	NOT COMPLETED	Arm I (4-OHT Topical Gel, Placebo)	5
Overall Study	NOT COMPLETED	Arm II (Placebo, Oral Tamoxifen)	5

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Arm I (4-OHT Topical Gel, Placebo)	2	47	47
other	Nausea	Gastrointestinal disorders	Arm II (Placebo, Oral Tamoxifen)	6	53	53
other	Fatigue	General disorders	Arm I (4-OHT Topical Gel, Placebo)	4	47	4
other	Fatigue	General disorders	Arm II (Placebo, Oral Tamoxifen)	5	53	6
other	Arthralgia	Musculoskeletal and connective tissue disorders	Arm I (4-OHT Topical Gel, Placebo)	3	47	3
other	Arthralgia	Musculoskeletal and connective tissue disorders	Arm II (Placebo, Oral Tamoxifen)	1	53	1
other	Myalgia	Musculoskeletal and connective tissue disorders	Arm I (4-OHT Topical Gel, Placebo)	2	47	2
other	Myalgia	Musculoskeletal and connective tissue disorders	Arm II (Placebo, Oral Tamoxifen)	4	53	4
other	Insomnia	Psychiatric disorders	Arm I (4-OHT Topical Gel, Placebo)	0	47	0
other	Insomnia	Psychiatric disorders	Arm II (Placebo, Oral Tamoxifen)	3	53	3

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (4-OHT Topical Gel, Placebo)	0	47
Total, all-cause mortality	Arm II (Placebo, Oral Tamoxifen)	0	53
Total, other adverse events	Arm I (4-OHT Topical Gel, Placebo)	27	47
Total, other adverse events	Arm II (Placebo, Oral Tamoxifen)	33	53
Total, serious adverse events	Arm I (4-OHT Topical Gel, Placebo)	0	47
Total, serious adverse events	Arm II (Placebo, Oral Tamoxifen)	0	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37870954	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA060553	The Robert H. Lurie Comprehensive Cancer Center	PLATANIAS, LEONIDAS C.	NORTHWESTERN UNIVERSITY	NATIONAL CANCER INSTITUTE	1993 to 2025

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I (4-OHT Topical Gel, Placebo) vs Arm II (Placebo, Oral Tamoxifen): deaths from any cause	Trial comparisons
Arm I (4-OHT Topical Gel, Placebo) vs Arm II (Placebo, Oral Tamoxifen): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02993159

GET https://conductscience.org/api/trials/v1/NCT02993159/results?page=2

API reference For AI assistants