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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Blood sample

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marleen Kok, MD; Phone Number: +31205129111; Email: m.kok@nki.nl
• Study Contact Backup: Name: Ingrid Mandjes; Email: i.mandjes@nki.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066CX
      • Antoni van Leeuwenhoek
      • Principal Investigator: Marleen Kok, MD
      • Contact: Laura Bornes, PhD
      • Contact: Veerle Geurts, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood sample; Collection of serum blood sample at day of start neo adjuvant treatment	Procedure: Blood sample; Collection of serum sample at the day of start of neo adjuvant treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR rate	Number of patients achieving a pathological complete response	At 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Residual cancer burden (RCB)	quantificaton of the residual disease after neoadjuvant therapy	At 6 months
Distant recurrence free interval (DRFI)	Number of patients with distant recurrence	Up to 120 months
Recurrence-free interval (RFI)	Number of patients with disease recurrence	Up to 120 months
Overall survival (OS)	Number of patients alive or deceased	Up to 120 months

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Investigators: Principal Investigator: Marleen Kok, MD, Antoni van Leeuwenhoek

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): July 15, 2035
• Study Completion (Estimated): July 15, 2036

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Triple negative tumor; Stage I - III disease; Starting neo adjuvant treatment; Regular physiological menstrual cycle (premenopausal)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: M23CMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: will follow

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No