Trial · NCT00045032
Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
NCT00045032, Phase 3, Completed, Hoffmann-La Roche; results first posted 2017-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer. Trials, record NCT00045032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00045032
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
- NCT number
- NCT00045032
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,099 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Breast Cancer
- Interventions
- Herceptin, Herceptin
- First posted
- 2003-01-27
- Last updated
- 2017-04-27
- Results first posted
- 2017-04-27
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | From Baseline until time of event (median of 1 year) | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. |
| Primary | Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | From Baseline until time of event (median of 1 year) | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. |
| Primary | DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | Year 2 | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. |
| Primary | DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | Year 2 | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. |
| Primary | Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up | From Baseline until time of event (median of 8 years) | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. |
| Primary | DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | Year 3 | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. |
| Primary | DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | Year 5 | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. |
| Primary | DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | Year 7 | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. |
| Primary | DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | Year 8 | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. |
| Primary | Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up | From Baseline until time of event (maximum of 10 years) | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | From Baseline until time of event (median of 1 year) | FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | From Baseline until time of event (median of 1 year) | FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint. | percentage of participants | NUMBER |
| PRIMARY | DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | Year 2 | FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint. | percentage of participants | NUMBER |
| PRIMARY | DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | Year 2 | FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up | From Baseline until time of event (median of 8 years) | FAS Population | percentage of participants | NUMBER |
| PRIMARY | DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | Year 3 | FAS Population | percentage of participants | NUMBER |
| PRIMARY | DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | Year 5 | FAS Population | percentage of participants | NUMBER |
| PRIMARY | DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | Year 7 | FAS Population | percentage of participants | NUMBER |
| PRIMARY | DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | Year 8 | FAS Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up | From Baseline until time of event (maximum of 10 years) | FAS Population | percentage of participants | NUMBER |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group237
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | Observation Arm | 12.9 | percentage of participants | ||
| Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | Herceptin 1-Year Arm | 7.5 | percentage of participants | ||
| Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | Observation Arm | 13.0 | percentage of participants | ||
| Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | Herceptin 2-Year Arm | 7.6 | percentage of participants | ||
| DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | Observation Arm | 78.18 | 95% Confidence Interval 75 to 81 | percentage of participants | |
| DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | Herceptin 1-Year Arm | 85.80 | 95% Confidence Interval 83 to 89 | percentage of participants | |
| DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | Observation Arm | 73.60 | 95% Confidence Interval 70 to 77 | percentage of participants | |
| DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | Herceptin 2-Year Arm | 87.50 | 95% Confidence Interval 85 to 90 | percentage of participants | |
| Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up | Observation Arm | 33.6 | percentage of participants | ||
| Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up | Herceptin 1-Year Arm | 27.7 | percentage of participants |
1 to 10 of 237Source ClinicalTrials.gov
See all 237 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Observation Arm | 1,697 | |
| Overall Study | STARTED | Herceptin 1-Year Arm | 1,702 | |
| Overall Study | STARTED | Herceptin 2-Year Arm | 1,700 | |
| Overall Study | Crossover to Adjuvant Herceptin | Observation Arm | 888 | |
| Overall Study | Crossover to Adjuvant Herceptin | Herceptin 1-Year Arm | 0 | |
| Overall Study | Crossover to Adjuvant Herceptin | Herceptin 2-Year Arm | 0 | |
| Overall Study | COMPLETED | Observation Arm | 834 | |
| Overall Study | COMPLETED | Herceptin 1-Year Arm | 994 | |
| Overall Study | COMPLETED | Herceptin 2-Year Arm | 974 | |
| Overall Study | NOT COMPLETED | Observation Arm | 863 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,290
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 | Cardiac failure congestive | Cardiac disorders | Observation Arm | 18 | 1,744 | |
| other | Cardiac failure congestive | Cardiac disorders | Herceptin 1-Year Arm | 78 | 1,682 | |
| other | Cardiac failure congestive | Cardiac disorders | Herceptin 2-Year Arm | 127 | 1,673 | |
| other | Palpitations | Cardiac disorders | Observation Arm | 20 | 1,744 | |
| other | Palpitations | Cardiac disorders | Herceptin 1-Year Arm | 72 | 1,682 | |
| other | Palpitations | Cardiac disorders | Herceptin 2-Year Arm | 84 | 1,673 | |
| other | Diarrhoea | Gastrointestinal disorders | Observation Arm | 22 | 1,744 | |
| other | Diarrhoea | Gastrointestinal disorders | Herceptin 1-Year Arm | 155 | 1,682 | |
| other | Diarrhoea | Gastrointestinal disorders | Herceptin 2-Year Arm | 180 | 1,673 | |
| other | Nausea | Gastrointestinal disorders | Observation Arm | 37 | 1,744 |
1 to 10 of 1,290Source ClinicalTrials.gov
See all 1,290 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Observation Arm | ||
| Total, all-cause mortality | Herceptin 1-Year Arm | ||
| Total, all-cause mortality | Herceptin 2-Year Arm | ||
| Total, other adverse events | Observation Arm | 1,076 | 1,744 |
| Total, other adverse events | Herceptin 1-Year Arm | 1,389 | 1,682 |
| Total, other adverse events | Herceptin 2-Year Arm | 1,440 | 1,673 |
| Total, serious adverse events | Observation Arm | 143 | 1,744 |
| Total, serious adverse events | Herceptin 1-Year Arm | 269 | 1,682 |
| Total, serious adverse events | Herceptin 2-Year Arm | 344 | 1,673 |
Source ClinicalTrials.gov
Papers19
The papers the trial lists on ClinicalTrials.gov.
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/NCT00045032
GET https://conductscience.org/api/trials/v1/NCT00045032/registered?page=2