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Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
RECRUITINGN/ASponsored by The Netherlands Cancer Institute
Actively Recruiting
PhaseN/A
SponsorThe Netherlands Cancer Institute
Started2025-10-14
Est. completion2035-07-15
Eligibility
Age18 Years – 59 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06273800
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
Eligibility
Age: 18 Years – 59 YearsSex: FEMALEHealthy volunteers accepted
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
Conditions2
Breast CancerCancer
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Actively Recruiting
PhaseN/A
SponsorThe Netherlands Cancer Institute
Started2025-10-14
Est. completion2035-07-15
Eligibility
Age18 Years – 59 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06273800