Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
Recruiting · NCT06273800 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Blood sample
What this trial is about
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
Who can take part
Age range
18 Years to 59 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Antoni van Leeuwenhoek - Amsterdam, North Holland, Netherlands