Analysis of molecular drivers in metastatic breast cancer

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 assess the molecular characteristics of metastatic breast cancer and how the disease evolves under treatment. It involves collecting biopsies and blood samples from patients to identify prognostic and predictive markers. The study will focus on understanding tumor evolution and developing biomarkers that indicate response or resistance to targeted therapies. By analyzing both tumor and normal tissue, researchers hope to gain insights into the mechanisms of resistance to treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with pathologically confirmed advanced breast cancer (ABC), including locally advanced inoperable disease and stage IV disease.
2. Age \> 18 years.
3. Performance status according to Eastern Cooperative Oncology Group (ECOG) ≤ 2.
4. ABC must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination, computerized tomography (CT-scan), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET).
5. Patients must have a radiological evaluation done maximum 6 weeks prior to inclusion.
6. Signed informed consent according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

Untreated psychiatric disorders that will impair the patient's ability to comply with study treatment or protocol.

Where it's running

• Lund University Hospital
  Lund, Sweden Recruiting
• Lund University Hospital
  Lund, Sweden Recruiting

Study contacts

• Study coordinator: Karolina Holm, PhD
• Email: karolina.holm@med.lu.se
• Phone: +46 730 84 17 61

Similar studies

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

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• Personalized treatment after endocrine therapy failure in metastatic breast cancer

  The study tests whether using a patient’s fresh tumor sample to try different drugs outside the body can help pick the next therapy for hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on endocrine therapy.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07895160

• SSGJ-612 plus a HER2-targeted ADC in HR-positive, HER2-low metastatic breast cancer

  This phase II study tests whether adding SSGJ-612 to a HER2-targeted antibody-drug conjugate helps people with HR-positive, HER2-low or ultralow metastatic breast cancer.

  Recruiting Phase 2 Shenyang Sunshine Pharmaceutical Co., LTD. · Guangzhou, Guangdong · NCT07757230

• SMP-656 in HER2-positive advanced breast cancer after ADC therapy

  This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.

  Recruiting Phase 2 Chengdu SciMount Pharmatech Co., Ltd. · Hefei, Anhui and 14 other locations · NCT07726342

• 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

• T-DXd–based therapy followed by targeted HER2 blockade and endocrine therapy in first-line HER2+ / HR+ metastatic breast cancer

  This trial tests a sequence of therapies starting with T-DXd plus pertuzumab, then a maintenance phase with dual HER2 blockade, endocrine therapy, and CDK4/6 inhibitor, with a retreatment option of T-DXd if disease progresses.

  Recruiting at 5 sites Phase 3 Daiichi Sankyo · Columbia, Maryland and 4 other locations · NCT07683754

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.