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This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood sample | Other | Collection of serum blood sample at day of start neo adjuvant treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Procedure | Collection of serum sample at the day of start of neo adjuvant treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | Number of patients achieving a pathological complete response | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological reduction on tumor size | Number of patients achieving a radiological response (CR, PR, SD) based on MRI after neo adjuvant treatment | At 6 months |
| Pathological reduction on tumor size |
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Inclusion Criteria:
Exclusion Criteria:
current use of hormonal contraception or in the six weeks prior to start of neoadjuvant systemic treatment for breast cancer, such as:
Oral contraception (OAC)
Hormonal intra-uterine device (IUD, Mirena)
No ovarian function suppression to preserve fertility
Other forms of hormonal contraception, including but not limited to: nuva-ring, Implanon, prikpil
Currently pregnant and / or breast feeding. In case of use of hormonal contraception or breast feeding in de last year: patients should have had at least 2 menstrual cycles since stopping hormonal contraception.
- active other malignancy
IVF-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Linn, MD | Contact | +31205129111 | s.linn@nki.nl | |
| Ingrid Mandjes | Contact | i.mandjes@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| Sabine Linn, MD | Antoni van Leeuwenhoek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoni van Leeuwenhoek | Recruiting | Amsterdam | North Holland | 1066CX | Netherlands |
will follow
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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collection of serum sample blood at first day of neo adjuvant treatment
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Number of patients achieving a pathological response (CR, PR, SD) based on pathology report after neo adjuvant
| At 6 months |
| Residual cancer burden (RCB) | quantificaton of the residual disease after neoadjuvant therapy | At 6 months |
| Distant recurrence free interval (DRFI) | Number of patients with distant recurrence | Up to 120 months |
| Recurrence-free interval (RFI) | Number of patients with disease recurrence | Up to 120 months |
| Overall survival (OS) | Number of patients alive or deceased | Up to 120 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |