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Blood markers may reveal hormone therapy success in breast cancer

NCT ID NCT01612871

Knowledge-focused Sponsor: Institut Claudius Regaud Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether tiny molecules called microRNAs in the blood can help predict if hormone therapy will work for women with advanced breast cancer. Researchers tested blood samples from 39 women before and after one month of treatment with tamoxifen or an aromatase inhibitor. The goal was to see if these microRNAs could serve as early indicators of treatment response, potentially guiding more personalized care in the future.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

39 people

The number who actually took part.

Started

Jun 2012

Finished

Jan 2016

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 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: 1. Women of more than 18 years old (menopausal or not) 2. Women with metastatic invasive breast cancer or locally advanced (without surgical project), for which treatment with tamoxifen or anti aromatase +/- LH-RH agonist, is indicated (anti-aromatase prescribed for menopausal womens; tamoxifen prescribed for both menopausal, pre menopausal or not menopausal womens). 3. Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (\>= 10% of tumor cells by IHC technique). Cancer HER2 negative. 4. Evaluable disease (measurable according RECIST criteria or not) 5. Any previous adjuvant hormone therapy should be discontinued for at least 21 days. 6. One or two prior metastatic lines of chemotherapy are allowed 7. General status WHO 0-2 8. The women of childbearing age must use an effective contraception for the duration of the study 9. Informed consent obtained and signed before any specific study procedure 10. Patient member in a national insurance scheme Exclusion Criteria: 1. Patient already treated with hormone therapy or not having stopped the previous adjuvant hormone therapy for at least 21 days. 2. Prescription of chemotherapy and / or other targeted therapy (other than hormone therapy) for the treatment of the breast cancer 3. Any previous hormone therapy for metastatic or locally advanced (without surgical project) breast cancer 4. Known hypercalcaemia before miRNA dosage at T=0 requiring immediate biphosphonate therapy 5. Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the the inclusion of the patient in the study inappropriate in the opinion of the investigator. 6. Patient unable to follow procedures, visits, examinations described in the study. 7. Pregnant women or nursing mothers will not participate in the study. 8. Patients under legal guardianship

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Centre Val d'Aurelle - Paul Lamarque

    Montpellier, 34298, France

  • Institut Claudius REGAUD Toulouse

    Toulouse, 31052, France

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