Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer

NCT06727227 | Recruiting FDA Drug

• 1 other identifier: D9673R00055
• Study Type: observational
• Target: 135
• Locations: 2 countries
• Sites: 14

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

Conditions

Breast Cancer

Outcome Measures

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.

  Baseline up to 19 months

Secondary Outcomes (15)

• Describe type and proportion of previous treatments for unresectable or mBC and comorbidities

  Baseline

• Duration of previous treatments and number of treatment lines

  Baseline

• Response to previous treatments

  Baseline

• Mean (SD) age at diagnosis

  Baseline

• Mean (SD) age at T-DXd start

  Baseline

Other Outcomes (8)

• Real-world Progression-Free Survival (rwPFS1, median, 95% CI, measured in months)

  Baseline up to 19 months

• Real-world Time to Second Next Treatment (rwTTNT2, median, 95% CI, in months)

  Baseline up to 19 months

• Real-world Time to Subsequent Treatment Discontinuation (rwTTD2, median, 95% CI, measured in months)

  Baseline up to 19 months

Interventions

trastuzumab deruxtecan DRUG

T-DXd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

Panagyurishte, Pazardzhik, 4500, Bulgaria

NOT YET RECRUITING

Research Site

Burgas, 8000, Bulgaria

RECRUITING

Research Site

Plovdiv, 4004, Bulgaria

NOT YET RECRUITING

Research Site

Sofia, 1303, Bulgaria

ACTIVE NOT RECRUITING

Research Site

Sofia, 1330, Bulgaria

ACTIVE NOT RECRUITING

Research Site

Sofia, 1407, Bulgaria

NOT YET RECRUITING

Research Site

Sofia, 1431, Bulgaria

ACTIVE NOT RECRUITING

Research Site

Sofia, 1527, Bulgaria

ACTIVE NOT RECRUITING

Research Site

Sofia, 1618, Bulgaria

NOT YET RECRUITING

Research Site

Sofia, 1756, Bulgaria

ACTIVE NOT RECRUITING

Research Site

Stara Zagora, 6003, Bulgaria

NOT YET RECRUITING

Research Site

Varna, 9003, Bulgaria

ACTIVE NOT RECRUITING

Research Site

Ljubljana, 1000, Slovenia

RECRUITING

Research Site

Maribor, 2000, Slovenia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center, Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 10, 2024
• Study Start: January 29, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

BU (12); SL (2)