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Trial Title:
Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
NCT ID:
NCT06273800
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Triple negative tumor
Stage I - III disease
Starting neo adjuvant treatment
Regular physiological menstrual cycle (premenopausal)
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
collection of serum sample blood at first day of neo adjuvant treatment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Blood sample
Description:
Collection of serum sample at the day of start of neo adjuvant treatment
Arm group label:
Blood sample
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
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
59 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Antoni van Leeuwenhoek
Address:
City:
Amsterdam
Zip:
1066CX
Country:
Netherlands
Contact:
Last name:
Laura Bornes, PhD
Contact backup:
Last name:
Veerle Geurts, PhD
Investigator:
Last name:
Marleen Kok, MD
Email:
Principal Investigator
Start date:
January 15, 2025
Completion date:
July 15, 2036
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06273800
