An Observational Follow-up Study of 1st-Line Treatment With Herceptin (Trastuzumab) in Patients With Metastatic Breast Cancer (Post-HERMINE)

Overall Survival Estimation After a 7 Year Follow-up in Metastatic Breast Cancer Patients Treated by Herceptin® as 1st Line Therapy (Post-HERMINE Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01332981

Enrollment

220

Registered

2011-04-11

Start date

2010-02-28

Completion date

2010-10-31

Last updated

2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female patient, \>/= 18 years of age * Metastatic breast cancer * 1st-line treatment with Herceptin initiated in 2002 * Included in pharmaco-epidemiologic HERMINE study

Exclusion criteria

* Patient died before scheduled follow-up visit (March 2005)

Design outcomes

Primary

Measure	Time frame	Description
Median Overall Survival	Up to 7 years	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.

Secondary

Measure	Time frame	Description
Median Time to Progression-Free Survival	Up to 7 years	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.
Median Time to Progression	Up to 7 years	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.
Median Treatment Duration and the Duration of Exposure to Trastuzumab	Up to 7 years	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.
Prognostic Factors for Overall Survival	Up to 7 years	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.
Prognostic Factors For Time to Progression	Up to 7 years	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

Countries

France

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	220
Total	220

Baseline characteristics

Characteristic	Transtuzumab
Age, Continuous	55.3 Years STANDARD_DEVIATION 12.3
Sex: Female, Male Female	220 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

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.

Time frame: Up to 7 years