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Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients

Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients

Recruiting
18-59 years
Female
Phase N/A

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Overview

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

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 details
    Breast Cancer

NCT06273800

The Netherlands Cancer Institute

1 February 2026

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