Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-59
SponsorThe Netherlands Cancer Institute
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Blood sample
Procedure/SurgeryCollection of serum sample at the day of start of neo adjuvant treatment
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Blood sampleOther 1 intervention
Trial outcomes
Primary outcomes
1
pCR rate
Number of patients achieving a pathological complete response
Time frame
At 6 monthsSecondary outcomes
1
Radiological reduction on tumor size
Number of patients achieving a radiological response (CR, PR, SD) based on MRI after neo adjuvant treatment
Time frame
At 6 months2
Pathological reduction on tumor size
Number of patients achieving a pathological response (CR, PR, SD) based on pathology report after neo adjuvant
Time frame
At 6 months3
Residual cancer burden (RCB)
quantificaton of the residual disease after neoadjuvant therapy
Time frame
At 6 months4
Distant recurrence free interval (DRFI)
Number of patients with distant recurrence
Time frame
Up to 120 monthsSponsors and contacts
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Source ClinicalTrials.gov