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Could your period affect chemo success? new study investigates

NCT ID NCT06273800

Knowledge-focused Sponsor: The Netherlands Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether the phase of a woman's menstrual cycle when she starts chemotherapy affects how well the treatment works for breast cancer. Researchers will collect a blood sample from 100 premenopausal women with triple-negative breast cancer on the day they begin neoadjuvant chemotherapy. The goal is to see if the timing is linked to a higher chance of a complete response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors personalize chemotherapy timing based on menstrual cycle to improve outcomes.
What could go wrong
This is an observational study, not a treatment trial. It may not find a clear link, and results may not change practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jul 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 59 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Antoni van Leeuwenhoek

    RECRUITING

    Amsterdam, North Holland, 1066CX, Netherlands

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