Clinical trial · Interventional
Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
NCT06273800CI-TRIAL-00097990ChemosenserecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Blood sample
- description
- Collection of serum blood sample at day of start neo adjuvant treatment
- interventionNames
- Procedure: Blood sample
Primary outcomes (1)
- measure
- pCR rate
- timeFrame
- At 6 months
- description
- Number of patients achieving a pathological complete response
Secondary outcomes (6)
- measure
- Radiological reduction on tumor size
- timeFrame
- At 6 months
- description
- Number of patients achieving a radiological response (CR, PR, SD) based on MRI after neo adjuvant treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.