Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Blood sample

• Registration Number: NCT06273800
• Lead Sponsor: The Netherlands Cancer Institute

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Study Start: 2025-01-15
• Primary Completion: 2035-07-15
• Study Completion: 2036-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sample	Blood sample	Collection of serum blood sample at day of start neo adjuvant treatment

Primary Outcome Measures

Name	Time	Method
pCR rate	At 6 months	Number of patients achieving a pathological complete response

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Antoni van Leeuwenhoek; 🇳🇱 Amsterdam, Noord-Holland, Netherlands