Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients (Chemosense)

Netherlands Cancer Institute (NKI)

Status

Enrolling

Conditions

Breast Cancer

Treatments

Procedure: Blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT06273800

M23CMC

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 59 years old

Volunteers

No 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