Sweden Cancerome Analysis Network - Breast Recurrence (SCAN-B-rec)

Recruiting

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT03758976
• Lead Sponsor: Lund University Hospital

Brief Summary

Prospective multicenter observational study to assess molecular drivers of metastatic breast cancer and disease evolution upon therapeutic pressure.

The main aim is to develop and validate prognostic, predictive and pathogenic markers in clinically well-characterized population-based material of breast cancer tumors and the corresponding normal tissue.These data will be used to characterize recurrent breast cancer on a molecular level, study tumor evolution, develop biomarkers of response/resistance to targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical studies and to elucidate mechanisms of resistance to therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Study Start: 2019-01-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2030-12-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	10 years	Prospective recording of treatment interventions and molecular characteristics in metastatic breast cancer patients until the date of Death.

Trial Locations

Locations (1)

Lund University Hospital; 🇸🇪 Lund, Sweden