NCT06727227 Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
| NCT ID | NCT06727227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 138 participants |
| Start Date | 2025-01-29 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 138 participants in total. It began in 2025-01-29 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
AstraZeneca Clinical Study Information Center, Study Information Center
✉ information.center@astrazeneca.com📞 1-877-240-9479
Frequently Asked Questions
Who can join the NCT06727227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06727227 currently recruiting?
Yes, NCT06727227 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06727227 trial being conducted?
This trial is being conducted at Panagyurishte, Bulgaria, Burgas, Bulgaria, Plovdiv, Bulgaria, Sofia, Bulgaria and 10 additional locations.
Who is sponsoring the NCT06727227 clinical trial?
NCT06727227 is sponsored by AstraZeneca. The trial plans to enroll 138 participants.
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