Mammacarcinoom Neoadjuvante Systeemtherapie

National Breast Cancer Surgery Snapshot Study: Breast cancer surgery after neoadjuvant systemic therapy in primary breast cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27051

Enrollment

185

Registered

2020-09-09

Start date

2021-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Breast cancer

Interventions

With this study we aim to provide societal and ethical justification. This is an observational research project, patients included in this research will not undergo any intervention or treatment as pa

Eligibility

Inclusion criteria

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 criteria: Exclusion of patients < 18 years, not receiving surgery, receiving palliative treatment, with a history of breast cancer, benign breast tumors, pregnancy.

Design outcomes

Primary

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

—

Contacts

Public ContactGaelle Kramer

Amsterdam UMC, locatie VUmc

gaellekramer@gmail.com0639777015

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)