Chemosensitivity during phases of the menstrual cycle in breast cancer patients

Conditions: breast cancer
triple negative
10006291

Registration Number: NL-OMON56658

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

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, either:
• 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.
- IVF-trajectory for egg cell preservation prior to start of neoadjuvant
systemic treatment
- Patients with known PCOS polycystic ovarian syndrome

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint of the study will be the rate of patients achieving a<br /><br>pathological complete response (pCR rate) after neo-adjuvant treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include: radiological and pathological reduction in tumor<br /><br>size, residual cancer burden (RCB), recurrence-free interval (RFI) and<br /><br>distant-recurrence free intervall (DRFI). </p><br>