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RecruitingNCT06273800ChemosenseUpdated Nov 26, 2025

Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients

An interventional study of Blood sample in Breast Cancer, sponsored by The Netherlands Cancer Institute. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 59 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Breast Cancer

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Keywords

  • Triple negative tumor
  • Stage I - III disease
  • Starting neo adjuvant treatment
  • Regular physiological menstrual cycle (premenopausal)
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Blood sample

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

    Procedure: Blood sample

Interventions

  • ProcedureBlood sample

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

06

What researchers measure

Primary outcomes

  1. pCR rate

    Number of patients achieving a pathological complete response

    Time frame: At 6 months

Secondary outcomes

  1. Radiological reduction on tumor size

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

    Time frame: At 6 months

  2. Pathological reduction on tumor size

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

    Time frame: At 6 months

  3. Residual cancer burden (RCB)

    quantificaton of the residual disease after neoadjuvant therapy

    Time frame: At 6 months

  4. Distant recurrence free interval (DRFI)

    Number of patients with distant recurrence

    Time frame: Up to 120 months

  5. Recurrence-free interval (RFI)

    Number of patients with disease recurrence

    Time frame: Up to 120 months

  6. Overall survival (OS)

    Number of patients alive or deceased

    Time frame: Up to 120 months

07

Study locations

1 of 1 sites recruiting
  • Antoni van Leeuwenhoek
    Amsterdam, North Holland 1066CX, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — will follow

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06273800
Lead sponsor
The Netherlands Cancer Institute
Responsible party
Sponsor
First posted
Feb 23, 2024
Start date
Oct 14, 2025
Primary completion
Jul 15, 2035 (estimated)
Completion
Jul 15, 2036 (estimated)
Last update
Nov 26, 2025

Study contacts

Sabine Linn, MD
Contact
s.linn@nki.nl
+31205129111
Ingrid Mandjes
Contact
i.mandjes@nki.nl
Sabine Linn, MD
principal investigator · Antoni van Leeuwenhoek

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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