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Timing matters: menstrual cycle may influence breast cancer treatment choices

NCT ID NCT05878314

Knowledge-focused Sponsor: University Hospital Tuebingen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the menstrual cycle and preoperative hormone therapy affect a marker called Ki67 in women with early hormone-positive breast cancer. Researchers will also see if adding a genetic test (PAM50) changes treatment recommendations. About 504 women will participate, and the goal is to better personalize adjuvant therapy decisions.

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 adjuvant treatment decisions for hormone-positive breast cancer patients.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change patient outcomes or lead to new therapies.

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.

Participants

About 504 people

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

Started

Apr 2023

Expected to finish

Apr 2035

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.

Who is studied

252 premenopausal + 252 postmenopausal patients with early HR+/HER2 neg breast cancer receiving either * Tamoxifen (group A) * Aromatase inhibitor (+ GnRH if premenopausal) (group B) * nothing (group C) treatment during a window of opportunity of 2-3 weeks prior to surgery. Treatment will be assessed by investigators' choice and the three groups will be limited to 84 premenopausal/postmenopausal patients in each group)

Ages

18 years and older

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 ≥ 18 years of age * histologically proven unilateral primary non-metastatic invasive breast cancer * Estrogen receptor (ER)-/ or Progesterone receptor (PR)- positive and HER2-negative * Ki67 from core biopsy is available * no lymph-node involvement by clinical evaluation and ultrasound (cN0) * not amendable to neoadjuvant chemotherapy * surgery or planned surgery at the Department for Women's Health, Tuebingen or Freiburg * planned preoperative endocrine treatment with Tamoxifen, Aromatase inhibitors, Goserelin or nothing for 2 - 4 weeks * written informed consent Exclusion Criteria: * ER-negative and PR-negative * HER2-positive * bilateral breast cancer * preexisting cancer disease within the last 10 years * preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria) * any systemic breast cancer therapy before inclusion into the trial * indication for neoadjuvant chemotherapy * any systemic therapy except Tamoxifen, Aromatase inhibitors, Goserelin before surgery * locally advanced, inoperable or metastatic breast cancer * pregnant or lactating patients * inadequate general condition (not fit for chemotherapy) * hormonal contraception within 6 months before inclusion

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer

As listed by the trial registrant

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

Hormone receptor positive HER-2 negative 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

  • Department of Women's Health

    RECRUITING

    Tübingen, 72076, Germany

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