Trial · NCT00290745
Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ
NCT00290745, Phase 1, Phase 2, Completed, University of California, San Francisco; results first posted 2020-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ. Trials, record NCT00290745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00290745
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ
- NCT number
- NCT00290745
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Breast Cancer
- Interventions
- letrozole, tamoxifen citrate, conventional surgery, neoadjuvant therapy
- First posted
- 2006-02-13
- Last updated
- 2020-12-04
- Results first posted
- 2020-12-04
- Limitations and caveats
All good cause efforts to retrieve the serious adverse event and non-serious adverse event data have been exhausted. Adverse event data are no longer accessible per institutional and contractual guidelines and hence not available to be reported.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography | Baseline and 6 months | Change in size of Ductal Carcinoma in situ (DCIS) for participants on hormonal therapy, as determined by mammography are determined by (1) largest diameter of tumor, as visualized on mammography (2) extent of disease on mammography (3) quantification of mammographically-detected change from baseline to 6-month and used to generate the change in tumor volume of mammographic extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes |
| Primary | Median Change in 6-month Tumor Volume Compared to Baseline Using Magnetic Resonance Imaging (MRI) | Baseline and 6 months | Change in size of Ductal Carcinoma in situ (DCIS) on hormonal therapy, as determined by MRI are determined by (1) largest diameter of tumor, as visualized on MRI (2) extent of disease on MRI (3) quantification of MR-detected change from baseline to 6-month and used to generate the change in tumor volume of MRI extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes. |
| Secondary | Number of Responders to Neoadjuvant Therapy at Month 3 | 3 months | MRI volume response at each time point was classified as follows: 90% image-complete response (ICR90) is defined as a \>90% reduction in tumor volume, 80% image-complete response (ICR80) is defined as an 81-90% reduction in tumor volume , partial response (PR) is defined as a 20-80% reduction in tumor volume, and sustained disease or progressive disease (SD/PD) defined as a \<20% reduction or increase in volume. |
| Secondary | Number of Responders to Neoadjuvant Therapy at Month 6 | 6 months | MRI volume response at each time point was classified as follows: 90% image-complete response (ICR90) is defined as a \>90% reduction in tumor volume, 80% image-complete response (ICR80) is defined as an 81-90% reduction in tumor volume , partial response (PR) is defined as a 20-80% reduction in tumor volume, and sustained disease or progressive disease (SD/PD) defined as a \<20% reduction or increase in volume. |
| Secondary | Median Reduction in Tumor Volume by Estrogen Receptor Hormone (ER H-) Quartile Group | Baseline and 6 months | Tumor volume changes between baseline and surgery were calculated at month 6 and compared across baseline ER Hormone (H-) Score quartile. The ER H- scores are a percentage that tells you how many cells out of 100 stain positive for hormone receptors. Each participant is assigned an ER H- score at baseline with the full score range between 0 (none have receptors) and 100 (all have receptors). The participants were grouped into quartiles (four equal groups) based on their baseline ER H- score. ER H- score and the reduction in tumor volume from baseline to month 6 was measured for each quartile group. |
| Secondary | Median Reduction in Tumor Volume by PgR H-score by Quartile Group | Baseline and 6 months | Tumor volume changes between baseline and surgery were calculated at month 6 and compared across baseline PgR Hormone (H-) Score quartile. The PgR H-scores are a percentage that tells you how many cells out of 100 stain positive for hormone receptors. Each participant is assigned a PgR H- score at baseline with the full PgR H score ranges between 0 (none have receptors) and 100 (all have receptors). The participants were grouped into quartiles (four equal groups) based on their baseline PgR H- score and the reduction in tumor volume from baseline to month 6 was measured for each quartile group. A wilcoxon sign rank tests were used to evaluate the significance of these changes |
| Secondary | Median Reduction in Tumor Volume by Ki-67 Average Score | Baseline and 6 months | Tumor volume changes between baseline and surgery were calculated at month 6 by Baseline Ki-67 Average Score which is divided into 2 groups: (1) \<=10% or (2) \>10% to 100%. In est results, the Ki-67 findings expressed as a percentage with less than 10% considered low Ki-67 expression and \> than 10% or higher considered high. A "high" score means that the breast tumor is more likely to be aggressive and spread quickly. A wilcoxon sign rank tests were used to evaluate the significance of these changes |
| Secondary | Correlation Between Pathologic Tumor Size at Radiographic (MRI) Tumor Size | 6 months | Correlations between pathologic tumor size and maximum diameters of baseline and 6-month MRI extent of disease were evaluated using Spearman correlation coefficient measure of association. The Spearman's rank-order correlation (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. |
| Secondary | Correlation Between Pathologic Tumor Size and Mammographic Tumor Size | 6 months | Correlations between pathologic tumor size and maximum diameters of baseline and pre-surgical mammographic extent of disease were evaluated using Spearman correlation coefficient measure of association. The Spearman's rank-order correlation (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. |
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 | Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography | Baseline and 6 months | Only 54 patients had evaluable mammograms at 6 months | change in tumor volume (mm) | MEDIAN |
| PRIMARY | Median Change in 6-month Tumor Volume Compared to Baseline Using Magnetic Resonance Imaging (MRI) | Baseline and 6 months | change in tumor volume (cm3) | MEDIAN | |
| SECONDARY | Number of Responders to Neoadjuvant Therapy at Month 3 | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Responders to Neoadjuvant Therapy at Month 6 | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Reduction in Tumor Volume by Estrogen Receptor Hormone (ER H-) Quartile Group | Baseline and 6 months | Only 46 participants had both evaluable ER scores at baseline and evaluable month 6 scans | decrease in tumor volume (cm^3) | MEDIAN |
| SECONDARY | Median Reduction in Tumor Volume by PgR H-score by Quartile Group | Baseline and 6 months | Only 45 participants had both evaluable PgR scores at baseline and evaluable month 6 scans | reduction in tumor volume (cm^3) | MEDIAN |
| SECONDARY | Median Reduction in Tumor Volume by Ki-67 Average Score | Baseline and 6 months | Only 45 participants had both evaluable Ki-67 scores at baseline and evaluable month 6 scan | reduction in tumor volume (cm^3) | MEDIAN |
| SECONDARY | Correlation Between Pathologic Tumor Size at Radiographic (MRI) Tumor Size | 6 months | Spearman correlation coefficient (rs) | NUMBER | |
| SECONDARY | Correlation Between Pathologic Tumor Size and Mammographic Tumor Size | 6 months | Only 54 patients had evaluable mammograms at 6 months | Spearman correlation coefficient (rs) | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography | Tamoxifen or Letrozole | -5.0 | Inter-Quartile Range -10.4 to 0.4 | change in tumor volume (mm) | |
| Median Change in 6-month Tumor Volume Compared to Baseline Using Magnetic Resonance Imaging (MRI) | Tamoxifen or Letrozole | -0.8 | Inter-Quartile Range -1.95 to 0.35 | change in tumor volume (cm3) | |
| Number of Responders to Neoadjuvant Therapy at Month 3 | Tamoxifen or Letrozole | ICR90 | 13 | Participants | |
| Number of Responders to Neoadjuvant Therapy at Month 3 | Tamoxifen or Letrozole | ICR80 | 10 | Participants | |
| Number of Responders to Neoadjuvant Therapy at Month 3 | Tamoxifen or Letrozole | PR | 27 | Participants | |
| Number of Responders to Neoadjuvant Therapy at Month 3 | Tamoxifen or Letrozole | SD/PD | 17 | Participants | |
| Number of Responders to Neoadjuvant Therapy at Month 6 | Tamoxifen or Letrozole | ICR90 | 22 | Participants | |
| Number of Responders to Neoadjuvant Therapy at Month 6 | Tamoxifen or Letrozole | ICR80 | 7 | Participants | |
| Number of Responders to Neoadjuvant Therapy at Month 6 | Tamoxifen or Letrozole | PR | 26 | Participants | |
| Number of Responders to Neoadjuvant Therapy at Month 6 | Tamoxifen or Letrozole | SD/PD | 12 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tamoxifen or Letrozole | 79 | |
| Overall Study | COMPLETED | Tamoxifen or Letrozole | 67 | |
| Overall Study | NOT COMPLETED | Tamoxifen or Letrozole | 12 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tamoxifen or Letrozole | 0 | 67 |
| Total, other adverse events | Tamoxifen or Letrozole | 0 | 0 |
| Total, serious adverse events | Tamoxifen or Letrozole | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19689789 | BACKGROUND |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00290745
GET https://conductscience.org/api/trials/v1/NCT00290745/results?page=2