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RECRUITINGNA

Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients

NCT06273800•The Netherlands Cancer Institute

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 - 59 years

Sex

FEMALE

Healthy Volunteers

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

Locations (1)

Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

Key Dates

Start Date

October 14, 2025

Primary Completion Date

July 15, 2035

Completion Date

July 15, 2036

Last Updated

November 26, 2025

Enrollment

100

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Blood sample

PROCEDURE

Contacts

Sabine Linn, MD

CONTACT

+31205129111 s.linn@nki.nl

Ingrid Mandjes

CONTACT

i.mandjes@nki.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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