Recruiting
Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
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
ClinicalTrials.gov IDNCT06273800
PhaseNA
Enrollment100
SponsorThe Netherlands Cancer Institute
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
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
- Procedure: Blood sample — Collection of serum sample at the day of start of neo adjuvant treatment
Primary outcomes
- pCR rate (At 6 months)
Eligibility information
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
Study locations
- Antoni van Leeuwenhoek, Amsterdam, North Holland 1066CX Netherlands
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.