Breast Cancer
Conditions
Keywords
Triple negative tumor, Stage I - III disease, Starting neo adjuvant treatment, Regular physiological menstrual cycle (premenopausal)
Brief summary
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
Interventions
PROCEDUREBlood sample
Collection of serum sample at the day of start of neo adjuvant treatment
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
collection of serum sample blood at first day of neo adjuvant treatment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Women with a new diagnosis of triple negative breast cancer who have not yet started systemic treatment. * Patients with stage I-III disease, patient with locoregional recurrence who have not been treated with chemotherapy before. , * Aged \< 60 years * Women having a (regular) physiological menstrual cycle * Patients who are assigned to receive neoadjuvant chemotherapy with or without immunotherapy, targeted therapy and endocrine therapy * Patients must be systemic treatment naïve for current malignancy (e.g. no chemotherapy, hormonal therapy or targeted therapy) * Signed written informed consent
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR rate | At 6 months | Number of patients achieving a pathological complete response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological reduction on tumor size | At 6 months | Number of patients achieving a pathological response (CR, PR, SD) based on pathology report after neo adjuvant |
| Residual cancer burden (RCB) | At 6 months | quantificaton of the residual disease after neoadjuvant therapy |
| Radiological reduction on tumor size | At 6 months | Number of patients achieving a radiological response (CR, PR, SD) based on MRI after neo adjuvant treatment |
| Recurrence-free interval (RFI) | Up to 120 months | Number of patients with disease recurrence |
| Overall survival (OS) | Up to 120 months | Number of patients alive or deceased |
| Distant recurrence free interval (DRFI) | Up to 120 months | Number of patients with distant recurrence |
Countries
Netherlands
Contacts
Primary ContactSabine Linn, MD
Backup ContactIngrid Mandjes
Outcome results
None listed