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This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival | The time between the first infusion of trastuzumab and the date of death from any cause. Participants who were still alive at the end of the post-HERMINE study or lost to follow-up were censored at the last date they were known to be alive. | Up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Progression-Free Survival | The Progression-Free Survival (PFS) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. Progression-Free Survival was estimated by using Kaplan-Meier method. |
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Inclusion Criteria:
Exclusion Criteria:
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metastatic breast cancer patients treated by Herceptin® as 1st line therapy
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuilly-sur-Seine | 92521 | France |
Overall analysis population was 220. During data check for the participants alive at the end of HERMINE study, it appeared that 1 participant was included twice. Thus, the real no. that started treatment with 1st-line trastuzumab therapy was 220 and not 221. Thus, the no. of participants still alive at the end of HERMINE study was 102 and not 103.
This post-HERMINE study was an observational, pharmaco-epidemiological, and retrospective study. Among the 102 participants who were alive at the end of the observation period in the HERMINE study, 69 were included in the post-HERMINE study from 31 centers in France. The study was conducted between 23 February 2010 to 15 October 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab | Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The full analysis population included participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transtuzumab | Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Overall Survival | The time between the first infusion of trastuzumab and the date of death from any cause. Participants who were still alive at the end of the post-HERMINE study or lost to follow-up were censored at the last date they were known to be alive. | Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy. | Posted | Median | 95% Confidence Interval | Years | Up to 7 years |
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Up to 7 Years
This observational retrospective study was conducted to provide an update to the OS of participants with metastatic breast cancer, 7 years after starting first-line treatment with trastuzumab in subgroup of participants included in HERMINE study. Therefore, serious adverse event and non-serious adverse event data were not collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trastuzumab | Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Up to 7 years |
| Median Time to Progression | The Time to Progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. If the cause of death was unknown, the death was considered for this analysis as due to the disease. All participants who did not progress, the death was considered to be due to the disease. | Up to 7 years |
| Median Treatment Duration and the Duration of Exposure to Trastuzumab | Treatment duration was defined as the time between the first and the last infusion of trastuzumab. Exposure duration was defined only for the participants who continued trastuzumab after HERMINE study, as the sum of treatment duration as part of HERMINE study and of the treatment durations as part of post-HERMINE study taking into account temporary treatment discontinuations. For analyses of treatment and exposure duration , dates of infusion of trastuzumab were missing for 18 participants, so treatment and exposure durations were calculated for only 202 participants. | Up to 7 years |
| Prognostic Factors for Overall Survival | Search for prognostic factors for OS was performed using Cox regression model. First, all parameters were analyzed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15%-level were retained for the multivariate model. For the multivariate analysis, two models were built for prognostic factors for OS. In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%. The variables n°5 and n°6 were found to be significantly associated, thus only the variable n°6 was tested in the Model 2. This variable was not retained by the stepwise selection in the Model 1, contrary to the variable n°5. | Up to 7 years |
| Prognostic Factors For Time to Progression | Prognostic factors for TTP were searched by using Cox regression model. First, all parameters were analysed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15% level were retained for multivariate model. For multivariate analyses, 2 models were built for prognostic factor of TTP. In Model 1, stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In Model 2, stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for exit was 5%. Six parameters remained in the Model 1 to search for prognostic factors of TTP. Once the correlated variables were removed, there were only 3 variables left in Model 2: the age was not kept by the stepwise selection. Results below are for Model 1 and similar results were obtained for Model 2 | Up to 7 years |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Median Time to Progression-Free Survival | The Progression-Free Survival (PFS) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. Progression-Free Survival was estimated by using Kaplan-Meier method. | Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy. | Posted | Median | 95% Confidence Interval | Years | Up to 7 years |
|
|
|
| Secondary | Median Time to Progression | The Time to Progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. If the cause of death was unknown, the death was considered for this analysis as due to the disease. All participants who did not progress, the death was considered to be due to the disease. | Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy. | Posted | Median | 95% Confidence Interval | Years | Up to 7 years |
|
|
|
| Secondary | Median Treatment Duration and the Duration of Exposure to Trastuzumab | Treatment duration was defined as the time between the first and the last infusion of trastuzumab. Exposure duration was defined only for the participants who continued trastuzumab after HERMINE study, as the sum of treatment duration as part of HERMINE study and of the treatment durations as part of post-HERMINE study taking into account temporary treatment discontinuations. For analyses of treatment and exposure duration , dates of infusion of trastuzumab were missing for 18 participants, so treatment and exposure durations were calculated for only 202 participants. | Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy. | Posted | Median | Full Range | Years | Up to 7 years |
|
|
|
| Secondary | Prognostic Factors for Overall Survival | Search for prognostic factors for OS was performed using Cox regression model. First, all parameters were analyzed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15%-level were retained for the multivariate model. For the multivariate analysis, two models were built for prognostic factors for OS. In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%. The variables n°5 and n°6 were found to be significantly associated, thus only the variable n°6 was tested in the Model 2. This variable was not retained by the stepwise selection in the Model 1, contrary to the variable n°5. | Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy. | Posted | Number | 95% Confidence Interval | Hazard Ratio | Up to 7 years |
|
|
|
| Secondary | Prognostic Factors For Time to Progression | Prognostic factors for TTP were searched by using Cox regression model. First, all parameters were analysed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15% level were retained for multivariate model. For multivariate analyses, 2 models were built for prognostic factor of TTP. In Model 1, stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In Model 2, stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for exit was 5%. Six parameters remained in the Model 1 to search for prognostic factors of TTP. Once the correlated variables were removed, there were only 3 variables left in Model 2: the age was not kept by the stepwise selection. Results below are for Model 1 and similar results were obtained for Model 2 | Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy. | Posted | Number | 95% Confidence Interval | Hazard Ratio | Up to 7 years |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D017437 |
| Skin and Connective Tissue Diseases |
| CNS metastases at begining of treatment, Yes/No |
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| Time of first metastases and dose (mnths), >1 mnth |
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| Time:Diagnosis and 1st metastic relapse <=/>=2 Yrs |
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| Time:Diagnosis and 1st metastic relapse <=/>=24 m |
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| CNS metastases at start of the treatment Yes/No |
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| Time of first metastases and dose (mnths), >1 mnth |
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| Age in class ≥50 years old / <50 years old |
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| Time:Diagnosis and 1st metastic relapse <=/>=2 Yrs |
|