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Recruiting

NCT Number: NCT06273800

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

Recruiting

Interested in participating?

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Key information

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antoni van Leeuwenhoek

Amsterdam, North Holland, 1066CX, Netherlands

Location status: Recruiting

Location contact

Ingrid Mandjes

CONTACT

[email protected]

Sabine Linn, MD

PRINCIPAL_INVESTIGATOR

Sarah Pruckl, PhD

CONTACT

[email protected]

0205129111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Procedure

Collection of serum sample at the day of start of neo adjuvant treatment

Primary outcomes

  1. pCR rate

    Time frame: At 6 months

    Number of patients achieving a pathological complete response

Secondary outcomes

  1. Radiological reduction on tumor size

    Time frame: At 6 months

    Number of patients achieving a radiological response (CR, PR, SD) based on MRI after neo adjuvant treatment

  2. Pathological reduction on tumor size

    Time frame: At 6 months

    Number of patients achieving a pathological response (CR, PR, SD) based on pathology report after neo adjuvant

  3. Residual cancer burden (RCB)

    Time frame: At 6 months

    quantificaton of the residual disease after neoadjuvant therapy

  4. Distant recurrence free interval (DRFI)

    Time frame: Up to 120 months

    Number of patients with distant recurrence

  5. Recurrence-free interval (RFI)

    Time frame: Up to 120 months

    Number of patients with disease recurrence

  6. Overall survival (OS)

    Time frame: Up to 120 months

    Number of patients alive or deceased

Study contacts

Contact information is provided by the study sponsor or research team.

Ingrid Mandjes

CONTACT

[email protected]

Sabine Linn, MD

CONTACT

[email protected]

+31205129111

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Acronym: Chemosense

Important dates

Study start
2025
Primary completion
2035
Study completion
2036
First posted
Feb 23, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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