Mammacarcinoom Neoadjuvante Systeemtherapie
- Conditions
- Breast cancer
- Registration Number
- NL-OMON27051
- Lead Sponsor
- one
- Brief Summary
Scientific publication
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 185
Inclusion Criteria
Inclusion of all patients with primary breast cancer receiving NST followed by a surgical procedure as breast conserving surgery or a mastectomy.
Exclusion Criteria
Exclusion of patients < 18 years, not receiving surgery, receiving palliative treatment, with a history of breast cancer, benign breast tumors, pregnancy.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome of this project is to create an overview of the different reasons to apply neoadjuvant systemic therapy in breast cancer patients in the Netherlands and hereby also to study the results of NST in the sense whether the upfront set goal has been reached. We furthermore hope to get insight in how often NST, in different breast cancer tumor types, results in conversion from mastectomy to BCT as well as how often NST results in axillary down staging by which ALND is omitted.<br><br>There will be two timepoints for collection data for this Snapshot registration, one at the multidisciplinary team discussion (MTD) pre-NST staging and one after the finale pathology results. Research data will be collected through our Snapshot score form and stored in Castor, an electronic database, according to Good Clinical Practice standards and will be handled confidentially and anonymously
- Secondary Outcome Measures
Name Time Method Secondary, this project will provide us with more knowledge about the surgical and indirectly cosmetic outcomes after NST and will give insight in local differences. This will finally contribute to decrease variation in clinical practice, resulting in more national homogeneity and better overall shared decision making. With this project we aspire the best treatment strategy for every primary breast cancer patient in the Netherlands.<br><br>There will be two timepoints for collection data for this Snapshot registration, one at the multidisciplinary team discussion (MTD) pre-NST staging and one after the finale pathology results. Research data will be collected through our Snapshot score form and stored in Castor, an electronic database, according to Good Clinical Practice standards and will be handled confidentially and anonymously