Breast Cancer
Conditions
Keywords
Breast Cancer, NIS, Ribociclib, Metastatic Breast Cancer, HR+, HER2-, Real World Evidence
Brief summary
This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy
Detailed description
This non-interventional study collects data from clinical practice capturing on effectiveness, safety and tolerability, duration of therapy, and quality of life of ribociclib in combination with an aromatase inhibitor/fulvestrant in daily routine and in line with the respective current German summary of product characteristics. In order to put these results into perspective, data is also collected on patients treated with endocrine therapy or chemotherapy for first line locally advanced or metastatic breast cancer. To gain insight into algorithms and outcome of sequential therapy, up to three lines of treatment are documented within this study. The information gathered and evaluated in this NIS is helping to answer open questions for the treatment of locally advanced/metastatic breast cancer and provides first insights into the treatment reality with ribociclib in this setting. This includes, but is not limited to, the questions on baseline demographics leading to a specific treatment decision, as well as efficacy and clinical routine related to treatment sequencing. In addition, data on the mutation status (including PIK3CA and BRCA1/2) is collected at different time points to generate insights into the clinical routine of mutation testing and to understand its impact on therapy sequencing.
Interventions
DRUGFirst-line Ribociclib + endocrine therapy
Ribociclib + letrozole, or Ribociclib + anastrazole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
DRUGFirst-line endocrine therapy
As of physicians choice
DRUGFirst-line chemtherapy
As of physicians choice
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a histological diagnosis of locally advanced/metastatic HR+/HER2- breast cancer. Histological diagnosis does not necessarily origin from metastasis, but must reflect the most recent disease status * No prior systemic treatment for locally advanced/metastatic disease in the palliative setting * The treating physician has made the decision to treat the patient * with ribociclib in combination with an aromatase inhibitor or fulvestrant as initial treatment in first line, or * endocrine therapy as initial treatment in first line (e.g. letrozole, anastrozole, fulvestrant), or * chemotherapy as initial treatment in first line (e.g. taxanes, capecitabine, with or without bevacizumab) * Written informed consent of the patient * Patient who initiated treatment for first line no longer than 4 weeks (28 days) prior to written informed consent for this study * Planned treatment is in line with the respective current German SmPC ("Summary of product characteristics") * Patient is ≥18 years
Exclusion criteria
* Patients unable to provide written informed consent * Contra-indication according to the respective current German SmPC ("Summary of product characteristics"), as judged by the treating physician * The patient is currently under active treatment in an investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to 88 months | Progression-free survival was defined as first intake of study medication in current-line therapy up to first documented progress or death from any cause in this treatment line. If a patient had not had an event, progression-free survival was censored at the end of the respective therapy line. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sequential progression-free survival (PFS_S) | Up to 88 months | Sequential progression-free survival up to second-line therapy was defined as time between first intake of study medication in first-line therapy up to progress or death after second-line therapy. Sequential progression-free survival up to third-line therapy was defined as time between first intake of study medication in first-line therapy up to progress or death after third-line therapy. Sequential progression-free survival for all further therapy lines were analyzed according to the definitions above. |
| Time to treatment failure (TTF) | Up to 88 months | Time to treatment failure (TTF) from current-line therapy was defined as time between first intake of study medication in current-line therapy up to therapy discontinuation because of progress, adverse events leading to discontinuation or death. |
| Time to first chemotherapy | Up to 88 months | Time to first chemotherapy was defined as time between first intake of study medication in first-line therapy up to first application of chemotherapy for patients enrolled in 1st line option ribociclib + AI/FU or endocrine therapy. |
| Time to next treatment / therapy (TTNT) after 1st line treatment | Up to 88 months | Time to next treatment / therapy (TTNT) was defined as time between first intake of study medication in first-line therapy up to first intake of medication in the next therapy line. |
| Overall survival (OS) | Up to 88 months | Overall survival (OS) was defined as time between first intake of study medication in first-line therapy up to death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. |
| Dose reduction | Up to 88 months | Dose reduction rates and reasons |
| Dose interruption | Up to 88 months | Dose interruption rates and reasons |
| Discontinuations | Up to 88 months | Discontinuations rates and reasons |
| Adherence - MMAS-8 questionnaire | Up to 87 weeks | Patient adherence for ribociclib was assessed using the MMAS-8 questionnaire. This questionnaire was only send to patients enrolled in the first-line option ribociclib + AI/FU. The score was analyzed using descriptive statistics and adherence categories low, medium and high were displayed by visit. Questionnaires were only included if all questionnaire items were answered. The total scale has a range of 0 to 8.0 where: * Low Adherence (\< 6) * Medium Adherence (6 to \<8) * High Adherence (= 8) |
| Number of participants with mutations | Up to 88 months | Number of participants with mutations will be collected |
| Quality of life for specific cohorts and treatment lines - EORTC QLQ-C30 | Up to 88 months | Quality of life during documented therapy lines was assessed using the EORTC QLQ-C30. Scale and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
| Quality of life for specific cohorts and treatment lines - EORTC QLQ-BR23 | Up to 88 months | Quality of life during documented therapy lines was assessed using the EORTC QLQ-BR23. Scale and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
| Quality of life for specific cohorts and treatment lines - HADS-D | Up to 88 months | Quality of life during documented therapy lines was assessed using the HADS-D. Scale ranges between 0 and 21, a high score means a high level of anxiety or depression. |
Countries
Germany
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed