Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients

Breast Cancer Clinical Trial

— Chemosense  

Official title:

Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06273800
• Other study ID #: M23CMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2024
• Est. completion date: July 15, 2036

Study information

• Verified date: June 2024
• Source: The Netherlands Cancer Institute
• Contact: Marleen Kok, MD
• Phone: +31205129111
• Email: m.kok[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 15, 2036
• Est. primary completion date: July 15, 2035
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Blood sample
Collection of serum sample at the day of start of neo adjuvant treatment

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR rate	Number of patients achieving a pathological complete response	At 6 months
Secondary	Radiological reduction on tumor size	Number of patients achieving a radiological response (CR, PR, SD) based on MRI after neo adjuvant treatment	At 6 months
Secondary	Pathological reduction on tumor size	Number of patients achieving a pathological response (CR, PR, SD) based on pathology report after neo adjuvant	At 6 months
Secondary	Residual cancer burden (RCB)	quantificaton of the residual disease after neoadjuvant therapy	At 6 months
Secondary	Distant recurrence free interval (DRFI)	Number of patients with distant recurrence	Up to 120 months
Secondary	Recurrence-free interval (RFI)	Number of patients with disease recurrence	Up to 120 months
Secondary	Overall survival (OS)	Number of patients alive or deceased	Up to 120 months