To determine whether sensitivity towards NAC varies during different phases of the menstrual cycle in breast cancer patients.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint of the study will be the rate of patients achieving a
pathological complete response (pCR rate) after neo-adjuvant treatment.
Secondary outcome
Secondary endpoints include: radiological and pathological reduction in tumor
size, residual cancer burden (RCB), recurrence-free interval (RFI) and
distant-recurrence free intervall (DRFI).
Background summary
In murine breast tumors, an increased sensitivity to neo-adjuvant chemotherapy
(NAC) was observed when NAC was initiated at the estrus stage (follicular
phase) compared to the diestrus stage (luteal phase). Moreover, preliminary
data from a retrospective study in premenopausal patients with luminal and
triple negative breast cancer (BC) showed similar results. To draw ultimate
conclusions whether the menstrual cycle stage determines chemosensitivity in
BC-patients and should guide treatment decisions, prospective validation in a
larger patient cohort is warranted.
This study is the prospective cohort were these findings are validated.
Study objective
To determine whether sensitivity towards NAC varies during different phases of
the menstrual cycle in breast cancer patients.
Study design
This study is a prospective, multicenter study in which a serum sample will be
collected at the day of starting NAC treatment in breast cancer patients.
Intervention
Collection of a serum sample (8,5mL) at first day of NAC prior to chemotherapy
administration.
Study burden and risks
An extra serum sample of 8,5mL will be collected at day 1, prior to NAC
administration. If possible, the extra sample will be collected simultaneously
with regular blood withdrawal. Patients could experience minor side effects
resulting from blood withdrawal including discomfort and small hematomas.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL85173.041.23 |