NCT06273800

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
124mo left

Started Oct 2025

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Oct 2025Jul 2036

First Submitted

Initial submission to the registry

February 15, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 14, 2025

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2035

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2036

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

9.8 years

First QC Date

February 15, 2024

Last Update Submit

November 21, 2025

Conditions

Breast Cancer

Keywords

Triple negative tumorStage I - III diseaseStarting neo adjuvant treatmentRegular physiological menstrual cycle (premenopausal)

Outcome Measures

Primary Outcomes (1)

  • pCR rate

    Number of patients achieving a pathological complete response

    At 6 months

Secondary Outcomes (6)

  • Radiological reduction on tumor size

    At 6 months

  • Pathological reduction on tumor size

    At 6 months

  • Residual cancer burden (RCB)

    At 6 months

  • Distant recurrence free interval (DRFI)

    Up to 120 months

  • Recurrence-free interval (RFI)

    Up to 120 months

  • +1 more secondary outcomes

Study Arms (1)

Blood sample

OTHER

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

Procedure: Blood sample

Interventions

Blood samplePROCEDURE

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

Blood sample

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, North Holland, 1066CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sabine Linn, MD

    Antoni van Leeuwenhoek

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Linn, MD

CONTACT

+31205129111s.linn@nki.nl

Ingrid Mandjes

CONTACT

i.mandjes@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: collection of serum sample blood at first day of neo adjuvant treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 23, 2024

Study Start

October 14, 2025

Primary Completion (Estimated)

July 15, 2035

Study Completion (Estimated)

July 15, 2036

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations

NL(1)