---
title: "Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study"
nct_id: NCT07108595
overall_status: COMPLETED
sponsor: The First Affiliated Hospital with Nanjing Medical University
study_type: OBSERVATIONAL
primary_condition: Breast Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07108595.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07108595"
ct_last_update_post_date: 2025-08-07
last_seen_at: "2026-05-12T07:13:10.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study

**NCT ID:** [NCT07108595](https://clinicaltrials.gov/study/NCT07108595)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 142
- **Lead Sponsor:** The First Affiliated Hospital with Nanjing Medical University
- **Conditions:** Breast Cancer
- **Start Date:** 2021-01-01
- **Completion Date:** 2024-12-31
- **CT.gov Last Update:** 2025-08-07

## Brief Summary

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

## Detailed Description

The DESTINY-Breast trials established trastuzumab deruxtecan (T-DXd) as a treatment significantly improving outcomes in human epidermal growth factor receptor 2 (HER2)-positive and HER2-low metastatic breast cancer (MBC). However, real-world effectiveness is susceptible to confounding factors. This multicenter, real-world study aims to systematically evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low MBC. Key clinicopathological parameters were to be integrated to develop an individualized prognostic prediction model, facilitating precision medicine implementation in clinical practice.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

1. history of interstitial lung disease
2. incomplete medical records
3. concurrent malignancies;
4. pregnancy or lactation
5. psychiatric disorders compromising treatment adherence
```

## Arms

- **Observational Group** — Patients receive T-DXd

## Interventions

- **T- Dxd** (DRUG) — T-DXd based therapy

## Primary Outcomes

- **Progression Free Survival (PFS)** _(time frame: 2 years)_ — 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.

## Secondary Outcomes

- **The Number of Participants Who Experienced Adverse Events (AE)** _(time frame: 2 years)_

## Locations (1)

- Jiangsu Provincial People's Hospital, Nanjing, JiangSu 210000, Nanjing, Jiangsu, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.jiangsu provincial people's hospital, nanjing, jiangsu 210000|nanjing|jiangsu|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07108595.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07108595*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*