Trial · NCT00952731
4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ
NCT00952731, Phase 2, Completed, Northwestern University; results first posted 2015-07-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ. Trials, record NCT00952731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00952731
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ
- NCT number
- NCT00952731
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Ductal Breast Carcinoma in Situ, Estrogen Receptor-positive Breast Cancer
- Interventions
- oral placebo, afimoxifene, tamoxifen citrate, placebo gel
- First posted
- 2009-08-06
- Last updated
- 2015-07-21
- Results first posted
- 2015-07-21
- Limitations and caveats
- The study was originally designed to enroll 112 participants, unfortunately, the shelf-life of the study drug expired which resulted in early closure of the study after only 31 participants.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment | Baseline and after 4-10 weeks of treatment | Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment). |
| Secondary | Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery | Baseline and after 4-10 weeks of treatment | Hot flashes were assessed by the Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire. This questionnaire measures the incidence of a number of symptoms by asking participants how frequently they experienced them on a scale of 0-4 (0 being Not at All and 4 being Extremely often). BESS questionnaire was administered at baseline and time of surgery. The incidence of vasomotor symptoms (including hot flashes, night sweats, and cold sweats) was measured at baseline (Day 0) and end of treatment prior to surgery (at least 4 weeks later or up to 10 weeks, depending on scheduled surgery date), and changes in the mean score for hot flashes were observed. |
| Secondary | Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Baseline to immediately before surgery (after approximately 4-10 weeks) | The difference between vWF coagulation protein in blood samples collected at baseline and before surgery were measured using the immune-turbidimetric assay. |
| Secondary | Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Baseline and immediately before surgery (after approximately 4-10 weeks) | The difference between Factor VIII coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits. |
| Secondary | Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Baseline and immediately before surgery (after approximately 4-10 weeks) | The difference between Factor IX coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits. |
| Secondary | Difference in Protein S Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Baseline and immediately before surgery (after approximately 4-10 weeks) | The difference between protein S coagulation protein in blood samples collected at baseline and before surgery was measured using an ELISA Kit. |
| Other | Compare Concentrations of Tamoxifen and Its Metabolites (4-hydroxytamoxifen, Endoxifen, N-desmethyl Tamoxifen (NDT)) Obtained From Samples on the Day of Surgery | Day of surgery (after approximately 4-10 weeks) | Concentrations of tamoxifen and its metabolites: 4-hydroxytamoxifen, endoxifen, and NDT were measured in breast tissue, blood, and Nipple Aspirate Fluid (NAF) that was collected on the day of surgery. |
| Other | Drug Metabolite Levels in the Two Study Groups by CYP2D6 Polymorphism Status | 28-70 days | Descriptive statistics and confidence intervals will be provided. |
| Other | 4-OHT Affects Known Tamoxifen-modulated Pathways | 28-70 days | Descriptive statistics and confidence intervals will be provided. |
| Other | TAM Metabolite Concentrations and Estrogen Response Markers in Nipple Aspiration Fluid (NAF) | 28-70 days | Descriptive statistics and confidence intervals will be provided. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment | Baseline and after 4-10 weeks of treatment | 18 total subjects were evaluable for immunohistochemistry marker testing including the Ki-67 labeling index. Of the 26 participants who completed study treatment 2 did not have matching samples available for testing and 6 were excluded because of insufficient DCIS lesion in their samples for testing. | percentage of 300 DCIS cells | MEAN |
| OTHER_PRE_SPECIFIED | Compare Concentrations of Tamoxifen and Its Metabolites (4-hydroxytamoxifen, Endoxifen, N-desmethyl Tamoxifen (NDT)) Obtained From Samples on the Day of Surgery | Day of surgery (after approximately 4-10 weeks) | |||
| OTHER_PRE_SPECIFIED | Drug Metabolite Levels in the Two Study Groups by CYP2D6 Polymorphism Status | 28-70 days | |||
| OTHER_PRE_SPECIFIED | 4-OHT Affects Known Tamoxifen-modulated Pathways | 28-70 days | |||
| OTHER_PRE_SPECIFIED | TAM Metabolite Concentrations and Estrogen Response Markers in Nipple Aspiration Fluid (NAF) | 28-70 days | |||
| SECONDARY | Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery | Baseline and after 4-10 weeks of treatment | 1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Baseline to immediately before surgery (after approximately 4-10 weeks) | 1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure. | percentage of vWF protein in blood | MEAN |
| OTHER_PRE_SPECIFIED | E and Z 4-OHT Isomers | 28-70 days | |||
| SECONDARY | Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Baseline and immediately before surgery (after approximately 4-10 weeks) | 1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure. | percentage Factor VIII protein in blood | MEAN |
| SECONDARY | Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Baseline and immediately before surgery (after approximately 4-10 weeks) | 1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure. | percentage of Factor IX protein in blood | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment | Treatment Gel + Oral Placebo | -3.4 | Standard Deviation 5.0 | percentage of 300 DCIS cells | |
| Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment | Placebo Gel + Oral Treatment | -5.1 | Standard Deviation 5.5 | percentage of 300 DCIS cells | |
| Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery | Treatment Gel + Oral Placebo | 0.33 | Standard Deviation 0.64 | units on a scale | |
| Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery | Placebo Gel + Oral Treatment | 0.55 | Standard Deviation 1.05 | units on a scale | |
| Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Treatment Gel + Oral Placebo | -2.6 | Standard Deviation 52.3 | percentage of vWF protein in blood | |
| Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Placebo Gel + Oral Treatment | 51.2 | Standard Deviation 71.0 | percentage of vWF protein in blood | |
| Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Treatment Gel + Oral Placebo | 8.7 | Standard Deviation 18.5 | percentage Factor VIII protein in blood | |
| Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Placebo Gel + Oral Treatment | 11.6 | Standard Deviation 17.3 | percentage Factor VIII protein in blood | |
| Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Treatment Gel + Oral Placebo | -5.6 | Standard Deviation 13.6 | percentage of Factor IX protein in blood | |
| Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery | Placebo Gel + Oral Treatment | 0.4 | Standard Deviation 10.2 | percentage of Factor IX protein in blood |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Gel + Oral Placebo | 13 | |
| Overall Study | STARTED | Placebo Gel + Oral Treatment | 14 | |
| Overall Study | Randomization | Treatment Gel + Oral Placebo | 13 | |
| Overall Study | Randomization | Placebo Gel + Oral Treatment | 14 | |
| Overall Study | Treatment & Pre-Surgery | Treatment Gel + Oral Placebo | 12 | |
| Overall Study | Treatment & Pre-Surgery | Placebo Gel + Oral Treatment | 14 | |
| Overall Study | Surgery | Treatment Gel + Oral Placebo | 12 | |
| Overall Study | Surgery | Placebo Gel + Oral Treatment | 14 | |
| Overall Study | Follow-up | Treatment Gel + Oral Placebo | 12 | |
| Overall Study | Follow-up | Placebo Gel + Oral Treatment | 14 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events108
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 | Sweating (Diaphoresis) | Blood and lymphatic system disorders | Treatment Gel + Oral Placebo | 4 | 12 | 10 |
| other | Sweating (Diaphoresis) | Blood and lymphatic system disorders | Placebo Gel + Oral Treatment | 6 | 14 | 30 |
| other | Edema | Blood and lymphatic system disorders | Treatment Gel + Oral Placebo | 2 | 12 | 2 |
| other | Edema | Blood and lymphatic system disorders | Placebo Gel + Oral Treatment | 1 | 14 | 1 |
| other | Hemorrhage, Gu::Vagina | Blood and lymphatic system disorders | Treatment Gel + Oral Placebo | 0 | 12 | 0 |
| other | Hemorrhage, Gu::Vagina | Blood and lymphatic system disorders | Placebo Gel + Oral Treatment | 1 | 14 | 1 |
| other | Hypertension | Cardiac disorders | Treatment Gel + Oral Placebo | 0 | 12 | 0 |
| other | Hypertension | Cardiac disorders | Placebo Gel + Oral Treatment | 1 | 14 | 1 |
| other | Insomnia | Endocrine disorders | Treatment Gel + Oral Placebo | 3 | 12 | |
| other | Insomnia | Endocrine disorders | Placebo Gel + Oral Treatment | 1 | 14 | 1 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Gel + Oral Placebo | ||
| Total, all-cause mortality | Placebo Gel + Oral Treatment | ||
| Total, other adverse events | Treatment Gel + Oral Placebo | 12 | 12 |
| Total, other adverse events | Placebo Gel + Oral Treatment | 14 | 14 |
| Total, serious adverse events | Treatment Gel + Oral Placebo | 0 | 12 |
| Total, serious adverse events | Placebo Gel + Oral Treatment | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 | NIH RePORTER |
| N01CN035157 | PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS-2-261035157 | BERGAN, RAYMOND C | NORTHWESTERN UNIVERSITY | DIVISION OF CANCER PREVENTION AND CONTROL | 2004 to 2006 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Treatment Gel + Oral Placebo vs Placebo Gel + Oral Treatment: serious adverse events |
Source 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.
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/NCT00952731
GET https://conductscience.org/api/trials/v1/NCT00952731/events?page=2