Detailed Description:
This non-interventional study will investigate the effectiveness withT-DXd, the demographic
and clinical characteristics of the patients, treatment patterns, tolerability, management of
adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low
unresectable and/or metastatic breast cancer. Patients will be treated according to the
proposed indication statement in the Summary of Product Characteristics (SmPC). No drug
product will be administered as part of this study.
Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin,
gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part
of the study.
Inclusion Criteria:
- Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of
unresectable and/or mBC
- Documented HER2-low status (IHC1+, IHC2+/ISH-)
- Patients who have received prior chemotherapy in the metastatic setting or patients
who have developed disease recurrence during or within 6 months of completing adjuvant
chemotherapy
- Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to
the physicians choice per SmPC
- Written and signed Informed Consent to participate in the study
Exclusion Criteria:
- Pregnancy or breastfeeding
- Patients who at time of data collection for this study are participating in or have
participated in an interventional study that remains blinded.
No specific exclusion criteria are defined, as patients will be treated according to the
proposed indication statements in the SmPC.
Primary outcome:
1. Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (Time Frame - Baseline up to 31 months)
Secondary outcome:
1. Type of Treatment Patterns in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (Time Frame - Baseline up to 31 months)
2. Number of Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only) (Time Frame - Baseline up to 31 months)
3. Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only) (Time Frame - Baseline up to 31 months)
4. Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (Time Frame - Baseline up to 31 months)
5. Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (Time Frame - Baseline up to 31 months):
The PGI-TT is designed to assess the treatment tolerability of the medicine. Participants will rate the bother associated with any treatment-related symptoms based on a 5-point scale ranging from 1 (not at all) to 5 (very much). Higher scores indicate a worse outcome.
6. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (Time Frame - Baseline up to 31 months):
The EORTC QLQ-C30 questionnaire is designed to measure cancer patients' physical, psychological and social functions. The EORTC QLQ-C30 scales and single-item scales range in score from 0 to 100. A higher score for the functioning scales and global health status denotes a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
7. Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary (Time Frame - Baseline up to 31 months)
- Trastuzumab deruxtecan (T-DXd):
This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice.
Trastuzumab (T-DXd) to be administered according to the SmPC.
Conventional therapy (eg. capecitabine, eribulin, gemcitabine, paclitaxel, nab paclitaxel) to be administered according to the SmPC.
Quelle: ClinicalTrials.gov
