Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient (age ≥18 years) with histological or cytological confirmed diagnosis of unresectable or mBC.
Documented HER2-low status (IHC1+, IHC2+/ISH-) in patients who have received prior chemotherapy in the metastatic setting or documented HER2-low status (IHC 1+, IHC 2+/ISH-) in patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Recent prior decision to initiate therapy of T-DXd per SmPC (up to 30 days). Documentation confirming this decision will be required and collected.
Able and willing to provide informed consent.
Disqualifiers
Pregnancy or breastfeeding.
History of other primary malignancies in 2 years prior to unresectable or mBC diagnosis.
Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
HER2-low status patients who have previously documented HER2+ status in the same tumor.
Trial population
Study Population: Criteria: Age: Adult patients (≥18 years). Diagnosis: Confirmed diagnosis of unresectable or metastatic breast cancer (mBC). HER2 Status: Documented HER2-low status. Treatment Decision: Patients for whom the decision to initiate trastuzumab deruxtecan (T-DXd) treatment has been made independently and prior to enrolment in the study. Enrollment: Timing: Patients must be enrolled within 30 days before the administration of the first T-DXd infusion. Consent: Patients must provide written informed consent for data collection.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
trastuzumab deruxtecan
DrugT-DXd
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Real-world Time to Next Treatment (rwTTNT1, median, 95% CI, measured in months)
The duration from initiation of trastuzumab deruxtecan (T-DXd) treatment to the start of the subsequent therapy or death from any cause, whichever occurs first, assessed up to 19 months.
Time frame
Baseline up to 19 monthsSecondary outcomes
1
Describe type and proportion of previous treatments for unresectable or mBC and comorbidities
Prior treatments: surgery, chemotherapy, radiotherapy, therapies in neoadjuvant/adjuvant/advanced setting; treatment line (special focus should be given on endocrine and chemotherapy recycling in the metastatic setting). The timeline for these treatments will include all therapies administered from the time of breast cancer diagnosis.
Time frame
Baseline2
Duration of previous treatments and number of treatment lines
Start and stop date, if available
Time frame
Baseline3
Response to previous treatments
To describe patients' response to previous treatment, as applicable: clinical response (partial response/complete response/stable disease/disease progression; if progression: date and site of progression)
Time frame
Baseline4
Mean (SD) age at diagnosis
Describe the patients' mean (SD) age at diagnosis
Time frame
BaselineOther outcomes
1
Real-world Progression-Free Survival (rwPFS1, median, 95% CI, measured in months)
Evaluate the duration from the start of T-DXd treatment until disease progression or death, whichever occurs first.
Time frame
Baseline up to 19 months2
Real-world Time to Second Next Treatment (rwTTNT2, median, 95% CI, in months)
Time frame
Baseline up to 19 months3
Real-world Time to Subsequent Treatment Discontinuation (rwTTD2, median, 95% CI, measured in months)
Time frame
Baseline up to 19 months4
Real-world progression free survival 2 (rwPFS2, median, 95% CI, measured in months)
Time frame
Baseline up to 19 monthsSponsors and contacts
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Source ClinicalTrials.gov