breast cancer triple negative breast cancer triple negative
Conditions
Interventions
Collection of a serum sample (8,5mL) two weeks prior to start of NAC and one at first day of NAC prior to chemotherapy administration.
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Women with a new diagnosis of triple negative breast cancer who have not yet started systemic treatment. • Aged < 50 years • Women who have a (regular) physiological menstrual cycle • Patients who are assigned to receive neoadjuvant chemotherapy with or without immunotherapy, targeted therapy • Patients must be systemic treatment naïve for current malignancy (e.g. no chemotherapy or targeted therapy) • Signed written informed consentRegistration cohort (NKI-AVL only)Hormonal contraceptive use less than 2 month before start NAC, or Use of LHRH analog for fertility preservation, or fertility preservation with oocyte/embryo cryopreservation preceding NAC
Exclusion criteria
Exclusion criteria: - current use of hormonal contraception or in the 2 months prior to start of neoadjuvant systemic treatment for breast cancer, either: • 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 recent use of hormonal contraception or if patient has given birth in de last year: patients should have had at least 2 menstrual cycles since stopping hormonal contraception. - IVF-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment - Patients with known PCOS polycystic ovarian syndrome- patients with locoregional recurrence of breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of the study will be the rate of patients achieving a pathological complete response (pCR rate) after neo-adjuvant treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: radiological and pathological reduction in tumor size, residual cancer burden (RCB), recurrence-free interval (RFI), distant-recurrence free intervall (DRFI), changes in menstrual cycle and changes in tumor micro environment. | — |
Countries
Netherlands
Contacts
Public ContactS.M. Pruckl
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed