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New treatment option for Breast Cancer
Official title Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
ClinicalTrials.gov ID: NCT06273800
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59, women only
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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. \-...
- IVF-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.