Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study

NCT07108595 | Completed

• 1 other identifier: 20250729TDXd
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low metastatic breast cancer

Conditions

Breast Cancer

Keywords

HER2-positive; HER2-low; T-DXd; Real-world study

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

  2 years

Secondary Outcomes (1)

• The Number of Participants Who Experienced Adverse Events (AE)

  2 years

Study Arms (1)

Observational Group

Patients receive T-DXd

Drug: T- Dxd

Interventions

T- Dxd DRUG

T-DXd based therapy

Observational Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer were eligible and received therapy. DXd was administered intravenously at 5.4 mg/kg every 3 weeks (21-day cycles) until disease progression or unacceptable toxicity. Dose adjustments were performed according to clinical status and treatment tolerance. Complete blood count with hepatic and renal function parameters were monitored before each cycle. Tumor response assessment via RECIST 1.1 criteria was conducted radiologically every two cycles.

You may qualify if:

• female patients aged ≥18 years;
• histologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH+) or HER2-low (IHC 1+ or IHC 2+/FISH-) disease;
• radiologically confirmed recurrent or metastatic disease;
• completion of ≥2 cycles of T-DXd therapy;
• comprehensive medical documentation;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤3;
• measurable target lesions according to RECIST 1.1

You may not qualify if:

• history of interstitial lung disease
• incomplete medical records
• concurrent malignancies;
• pregnancy or lactation
• psychiatric disorders compromising treatment adherence

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial People's Hospital, Nanjing, JiangSu 210000

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: January 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)