Latest database descriptions

A French retrospective study describing the epidemiology and the therapeutic management of patients treated by Herceptin® based neoadjuvant treatment for HER2-positive early breast cancer.

August 23 2022

Primary objective: To describe therapeutic management of HER2-positive early breast cancer adults’ patients who have received an adjuvant treatment following Herceptin® based neoadjuvant therapy and breast surgery.

Secondary objectives:
The 2 key secondary objectives are:
1. To describe the clinical characteristics of the patients included in the cohort, overall and per pathological response status;
2. To measure the invasive disease-free survival (IDFS) and overall survival (OS), according to pathologic response status.

Other objectives:
3. To characterize adjuvant treatment failure outcomes including death, disease progression, and relapses;
4. To describe health care resources utilization by the targeted patients;
5. To estimate the number of HER2-positive early breast cancer patients who underwent breast surgery following Herceptin® based neoadjuvant treatment in France over a year (through the constitution of a registry of these patients) and number of HER2 positive early breast cancer patients with non pCR.

An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer

August 23 2022

Primary objective: To describe the systemic safety and local tolerability of subcutaneous Herceptin® (SC) in patients with HER2-positive early breast cancer (eBC), naive and non-naive of HER2+ treatment, treated in the neoadjuvant and adjuvant setting in routine clinical practice use.

Secondary objective:
To describe the quality of life (QoL) of patients (using the European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 questionnaire)
- The description of the baseline and disease characteristics of patients with HER2+ eBC initiating a treatment with Herceptin® SC;
- The description of use of Herceptin® SC (treatment duration, frequency of injections and sites of injection).

A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients ...

August 23 2022

Primary objective: This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years.

Secondary objectives:
The secondary objectives of this study were to describe:
- The progression-free survival, time to progression and patients overall survival;
- Modalities of use of trastuzumab, the duration of treatment and the reasons leading to treatment discontinuation;
- Antineoplastic treatments in combination with trastuzumab and after discontinuation of trastuzumab treatment;
- Relevant biological tumor markers;
- The safety of trastuzumab treatment.

Impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with C.E.R.A

August 23 2022

Primary objective: To describe in CKD patients on dialysis the impact of comorbidities* on hemoglobin stability** after 6 months of treatment with Mircera® in routine clinical practice
* Patients’ comorbidities will be analyzed on the basis of the CCI.
** Hemoglobin stability is defined as a variation of +/- 1g/dL of hemoglobin level between the first Mircera® injection and the 6th month of treatment, without red blood cells transfusion during this period.

Secondary objectives:
- In the overall study population and in each subgroup of patients defined by a range of the Charlson comorbidity index (<=3, [4-5], [6-7], >=8):
- - To describe baseline characteristics of the patients;
- - To describe the monthly changes in hemoglobin level;
- - To describe monthly Mircera® dose.
- To describe patients’ vital status and all adverse events over the observation period with Mircera®;
- To describe the hemoglobin stability after 6 months of treatment with Mircera®, according to subgroups of Liu comorbidity index (<=3; [4-6]; [7-9]; >=10);
- To describe the proportion of patients with an Hb level within the range 10-12 g/dL with or without hemoglobin stability after 6 months of treatment with Mircera®, according to the subgroups of Charlson and Liu comorbidity indexes.

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