Observational study on HER2-low breast cancer treatment with Trastuzumab Deruxtecan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low breast cancer who have previously undergone chemotherapy. It will collect data on patient demographics, clinical characteristics, treatment patterns, tolerability, and management of adverse drug reactions. Patients will receive treatment according to the established guidelines without the administration of any additional drug products as part of the study. Additionally, data on conventional chemotherapy treatments will be gathered to enhance understanding of treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Study Group 1 and Study Group 2

* Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
* Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC
* Written and signed Informed Consent to participate in the study

Study Group 1

* Documented HER2-low status (IHC1+, IHC2+/ISH-)
* Patients who have received prior chemotherapy in the metastatic setting or
* Patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy

Study Group 2:

* Documented HR+ status
* Documented HER2-low status (IHC1+ or IHC2+/ISH-) or HER2-ultralow (defined as IHC 0 with membrane staining \[IHC \> 0 to \<1+\]) status
* Patients who have received at least one endocrine therapy in the metastatic setting
* Patients who have NOT received prior chemotherapy in the metastatic setting

Exclusion Criteria:

Study Group 1 and Study Group 2

* Pregnancy or breastfeeding
* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.

No other specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.

Where it's running

• Medizinische Universität Graz
  Graz, Austria Recruiting
• Medizinische Universität Innsbruck
  Innsbruck, Austria Recruiting
• Klinikum Klagenfurt am Wörthersee
  Klagenfurt, Austria Recruiting
• Ordensklinikum Linz GmbH Barmherzige Schwestern
  Linz, Austria Recruiting
• KH der Barmherzigen Brüder Salzburg
  Salzburg, Austria Recruiting
• Uniklinikum Salzburg
  Salzburg, Austria Recruiting

+166 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Contact for Clinical Trial Information
• Email: CTRinfo@dsi.com
• Phone: 908-992-6400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Elacestrant plus trastuzumab deruxtecan for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after CDK4/6 and endocrine therapy

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• Tucatinib plus trastuzumab for HER3-mutant, HER2-not amplified metastatic breast cancer

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  Recruiting Phase 2 Institut Curie · Bordeaux and 8 other locations · NCT07193394

• Bevacizumab added or not to T-DXd for HER2-low breast cancer with brain metastases

  This trial tests whether adding bevacizumab to trastuzumab deruxtecan helps people with HER2-low breast cancer that has spread to the brain.

  Recruiting Phase 2 Fudan University · Shanghai · NCT07150208

• Treatment options after targeted therapy stops working in advanced breast cancer

  This study will see how well different treatments work for people with advanced breast cancer who have stopped responding to CDK4/6 inhibitors, PIK3CA inhibitors, or T-DXd.

  Recruiting Hunan Cancer Hospital · Changsha, Hunan · NCT07073755

• Toxicity markers for Trastuzumab‑Deruxtecan in advanced breast cancer

  This project will test whether blood markers can predict serious side effects, including interstitial lung disease, in adults with metastatic HER2‑positive or HER2‑low breast cancer who are treated with Trastuzumab‑Deruxtecan.

  Recruiting European Institute of Oncology · Milan · NCT07049133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.