Breast CancerChemosenseNCT06273800
Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
A study testing Blood sample in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 59 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Oct 2025to 15 Jul 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ingrid Mandjes contact
Netherlands1 site, 1 recruiting
- Recruiting
Antoni van Leeuwenhoek
Amsterdam, North Holland, 1066CX
Sarah Pruckl, PhD, 0205129111, chemosense@nki.nl
Ingrid Mandjes, i.mandjes@nki.nl
About this study
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
- Breast Cancer
- Being tested
- Blood sample
- Keywords
- Triple negative tumor, Stage I - III disease, Starting neo adjuvant treatment, Regular physiological menstrual cycle (premenopausal)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Collection of serum sample at the day of start of neo adjuvant treatment
| Study group | Role | What they receive |
|---|---|---|
| Blood sample | Other | Collection of serum blood sample at day of start neo adjuvant treatment Receives: Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
Number of patients achieving a pathological complete response
Measured: At 6 months
Secondary outcomes (6)
Radiological reduction on tumor size
Number of patients achieving a radiological response (CR, PR, SD) based on MRI after neo adjuvant treatment
Measured: At 6 months
Pathological reduction on tumor size
Number of patients achieving a pathological response (CR, PR, SD) based on pathology report after neo adjuvant
Measured: At 6 months
Residual cancer burden (RCB)
quantificaton of the residual disease after neoadjuvant therapy
Measured: At 6 months
Distant recurrence free interval (DRFI)
Number of patients with distant recurrence
Measured: Up to 120 months
Recurrence-free interval (RFI)
Number of patients with disease recurrence
Measured: Up to 120 months
Overall survival (OS)
Number of patients alive or deceased
Measured: Up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start14 Oct 2025
- Primary completion15 Jul 2035 (estimated)
- Study completion15 Jul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- collection of serum sample blood at first day of neo adjuvant treatment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Linn, MD, Principal investigator, Antoni van Leeuwenhoek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273800
- Sponsor's protocol ID
- M23CMC
- Acronym
- Chemosense
- Status last verified
- Nov 2025
- First submitted
- 15 Feb 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will follow
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06273800
- Acronym / sponsor ID
- Chemosense / M23CMC
- Conditions
- Breast Cancer
- Keywords
- Triple negative tumor, Stage I - III disease, Starting neo adjuvant treatment, Regular physiological menstrual cycle (premenopausal)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 15 Jul 2035 (estimated)
- Study completion
- 15 Jul 2036 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- collection of serum sample blood at first day of neo adjuvant treatment
| Arm | Type | Receives |
|---|---|---|
| Blood sample | Other | Procedure: Blood sampleCollection of serum blood sample at day of start neo adjuvant treatment |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleCollection of serum sample at the day of start of neo adjuvant treatment | Procedure or surgery | Blood sample |
Primary outcome
pCR rate
Time frame: At 6 months
Number of patients achieving a pathological complete response
6 secondary outcomes
Radiological reduction on tumor size
Time frame: At 6 months
Pathological reduction on tumor size
Time frame: At 6 months
Residual cancer burden (RCB)
Time frame: At 6 months
Distant recurrence free interval (DRFI)
Time frame: Up to 120 months
Recurrence-free interval (RFI)
Time frame: Up to 120 months
Overall survival (OS)
Time frame: Up to 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Undecided. will follow
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ingrid Mandjes contact
Sabine Linn, MD principal investigator
Antoni van Leeuwenhoek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Linn, MD (+31205129111, s.linn@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.