Trial · NCT00496808
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
NCT00496808, Not applicable, Completed, M.D. Anderson Cancer Center; results first posted 2012-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast. Trials, record NCT00496808. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00496808
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
- NCT number
- NCT00496808
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 69 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Ductal Carcinoma In Situ
- Interventions
- Herceptin (Trastuzumab)
- First posted
- 2007-07-04
- Last updated
- 2020-09-23
- Results first posted
- 2012-05-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Proliferation as Measured by Ki-67 | Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks | Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67. |
| Primary | Number of Participants Achieving Documented Change in Proliferation | Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks | Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student's t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups. |
| Secondary | Mean Percent of Ki-67 | Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks | Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Proliferation as Measured by Ki-67 | Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks | |||
| PRIMARY | Number of Participants Achieving Documented Change in Proliferation | Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks | Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable. | Participants | NUMBER |
| SECONDARY | Mean Percent of Ki-67 | Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks | Analysis was per protocol. Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable. | Percentage of Ki-67 | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Documented Change in Proliferation | Herceptin | 12 | Participants | ||
| Mean Percent of Ki-67 | Herceptin | 44.29 | Standard Deviation 3.42 | Percentage of Ki-67 |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Herceptin | 69 | |
| Overall Study | COMPLETED | Herceptin | 69 | |
| Overall Study | NOT COMPLETED | Herceptin | 0 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Infusion reaction | General disorders | Herceptin | 2 | 69 | 2 |
| serious | Neuropathy: Sensory | Nervous system disorders | Herceptin | 1 | 69 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Herceptin | ||
| Total, other adverse events | Herceptin | 0 | 69 |
| Total, serious adverse events | Herceptin | 3 | 69 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00496808
GET https://conductscience.org/api/trials/v1/NCT00496808/registered