The catalog contains the description of the main databases in public health in France
August 23 2022
Primary objective: Positive HER2 status is defined as IHC3+ or IHC2+/ISH+, as per the Herceptin® SPC.
Secondary objectives:
Evaluated according to HER2 status determined by the centralized laboratory
- Describe pathological features of the tumors (assessed locally) according to HER2 status;
- Evaluate concordance between IHC 4B5 and SISH results for each sample;
- Evaluate concordance between HER2 status determined on biopsies and surgical specimens (globally and according to use or not of neoadjuvant chemotherapy);
- Describe expression of the following markers: HER3, HER4, PTEN, cMET, Bcl2, p53.
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.
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).
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.
The catalog contains the description of the main databases in public health in France
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