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PRIMROSE Tissue: collection and analysis of samples in breast cancer

Primrose tissue study: a collection and analysis of tissue and CSF samples from patients with CNS disease secondary to breast cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13938848
Enrollment
300
Registered
2021-05-21
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Cancer Malignant neoplasm of breast

Interventions

Data and Tissue Collection After Enrolment After written consent is given and after patient has been enrolled in the study the data should be entered into the database (from retrospect

Sponsors

University of Liverpool
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 16 years of age or above 2. Histologically and/or cytologically confirmed breast cancer with CNS involvement, as defined as having one or more of the following: 2.1. Metastases to the brain parenchyma 2.2. Metastases to the leptomeninges 2.3. Paraneoplastic Neurological Disorders 3. FFPE of biopsied or resected primary breast cancer, non-CNS metastasis and/ or brain metastasis is available or will be available. 4. Informed consent

Exclusion criteria

Exclusion criteria: 1.Unable to comply with study procedures or give informed consent

Design outcomes

Primary

MeasureTime frame
Clinical staff will be collecting information onto eCRFs (REDCap) at registration (1st or 2nd Visit), CSF Extraction Visit, Imaging/ Scan Visit, Disease Progression Visit: 1. Disease history and characteristics 2. Prior cancer therapy (top line) 3. Current anti-cancer treatment and concomitant medications Progression Details

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026