Chemosensitivity across menstrual cycle phases in premenopausal triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter study enrolling premenopausal women with newly diagnosed stage I–III triple-negative breast cancer who have not yet received systemic therapy. A serum sample is collected on the day neoadjuvant treatment begins and will be used to study biomarkers of chemosensitivity in relation to menstrual cycle phase. Patients using hormonal contraception or with suppressed ovarian function are excluded to preserve natural cycle effects. The goal is to correlate blood-based signals with cycle timing and planned neoadjuvant therapy to inform whether cycle phase influences treatment response.

Why it matters

Who can join: the full rules

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's running

• Antoni van Leeuwenhoek
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Sabine Linn, MD — Antoni van Leeuwenhoek
• Study coordinator: Sabine Linn, MD
• Email: s.linn@nki.nl
• Phone: +31205129111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.