Breast CancerPhase 4MIRHONCT01612871
Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer
A Phase 4 study testing Tamoxifen, Letrozole , Anastrozole, Exemestane in people with Breast Cancer, run by Institut Claudius Regaud at 2 sites in France.
Trial summary
This is a biomedical and prospective study of interventional type. The trial will include 29 patients over a period of 15 months + 24 months of follow up maximum. The study will be conduct in womens with metastatic invasive breast cancer or locally advanced breast cancer and for which treatment with tamoxifen or anti… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen, Letrozole , Anastrozole, Exemestane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Jun 2012to 28 Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of more than 18 years old (menopausal or not)
- 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).
- Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (>= 10% of tumor cells by IHC technique).
- Cancer HER2 negative.
- Evaluable disease (measurable according RECIST criteria or not)
Show all 12Show fewer
- Any previous adjuvant hormone therapy should be discontinued for at least 21 days.
- One or two prior metastatic lines of chemotherapy are allowed
- General status WHO 0-2
- The women of childbearing age must use an effective contraception for the duration of the study
- Informed consent obtained and signed before any specific study procedure
- Patient member in a national insurance scheme
Who cannot join
- Patient already treated with hormone therapy or not having stopped the previous adjuvant hormone therapy for at least 21 days.
- Prescription of chemotherapy and / or other targeted therapy (other than hormone therapy) for the treatment of the breast cancer
- Any previous hormone therapy for metastatic or locally advanced (without surgical project) breast cancer
- Known hypercalcaemia before miRNA dosage at T=0 requiring immediate biphosphonate therapy
- 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.
- Patient unable to follow procedures, visits, examinations described in the study.
- Pregnant women or nursing mothers will not participate in the study.
- Patients under legal guardianship
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Val d'Aurelle - Paul Lamarque
Montpellier, 34298
Institut Claudius REGAUD Toulouse
Toulouse, 31052
About this study
Official title: Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer? Pilot Study.
This is a biomedical and prospective study of interventional type. The trial will include 29 patients over a period of 15 months + 24 months of follow up maximum.
The study will be conduct in womens with metastatic invasive breast cancer or locally advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line hormone therapy for metastatic breast cancer) is indicated.
Read more
The main objective of this pilot study is to evaluate the feasibility to detect in the circulating blood of patients, before treatment (T0), the presence of the fifteen tissular microRNAs described in preclinical studies as possibly involved in hormone resistance/sensitivity.
In parallel of the detection of these specific miRNAs, we will conduct a larger scale analysis of circulating miRNAs in these patients before (T = 0) and after one month of treatment (T28).
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen, Letrozole , Anastrozole, Exemestane
- Keywords
- Breast cancer,, hormonotherapy,, miRNAs,, biomarkers, hormone therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen, Letrozole , Anastrozole, ExemestaneDrug
Current first line metastatic hormone therapy treatment in hormone dependent breast cancer :
Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day
| Study group | Role | What they receive |
|---|---|---|
| hormone therapy treatment | Experimental | Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day Receives: Drug: Tamoxifen, Letrozole , Anastrozole, Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of patients for which specific tissular miRNAs are detected in blood before treatment (D0)
MiRNAs will be quantified in plasma using qPCR (quantitative Polymerase Chain Reaction) with the kit "miScriptSYBR Green PCR" (Qiagen)
Measured: 1 time point (D0) over a period of 39 months
Secondary outcomes (4)
Analysis of the larger-scale circulating miRNAs in plasma of these patients before (D0) and after one month (D28) of treatment with tamoxifen or anti aromatase
Measured: 2 time points (D0 and D28) over a period of 39 months (3 years and 3 months)
Correlation between the specific miRNAs initial expression and the appearance of an objective response or clinical benefit of hormone therapy and the time to progression
Measured: 39 months (3 years and 3 months)
Rate of objective responses, defined as the number of patients with a complete or partial response.
Measured: 39 months (3 years and 3 months)
The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
Measured: 39 months (3 years and 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study start27 Jun 2012
- Primary completion28 Jan 2016
- Study completion28 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence DALENCr, PhD, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612871
- Sponsor's protocol ID
- 11SEIN12
- Acronym
- MIRHO
- Status last verified
- Apr 2026
- First submitted
- 4 Jun 2012
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacot W, Dalenc F, Lopez-Crapez E, Chaltiel L, Durigova A, Gros N, Lozano N, Lacaze JL, Pouderoux S, Gladieff L, Romieu G, Roche H, Filleron T, Lamy PJ. PIK3CA mutations early persistence in cell-free tumor DNA as a negative prognostic factor in metastatic breast cancer patients treated with hormonal therapy. Breast Cancer Res Treat. 2019 Oct;177(3):659-667. doi: 10.1007/s10549-019-05349-y. Epub 2019 Jul 11.
PubMed 31297647
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer? Pilot Study.
- ClinicalTrials.gov ID
- NCT01612871
- Acronym / sponsor ID
- MIRHO / 11SEIN12
- Conditions
- Breast Cancer
- Keywords
- Breast cancer,, hormonotherapy,, miRNAs,, biomarkers, hormone therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 27 Jun 2012 (actual)
- Primary completion
- 28 Jan 2016 (actual)
- Study completion
- 28 Jan 2016 (actual)
- First posted
- 6 Jun 2012 (estimated)
- 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 is a biomedical and prospective study of interventional type. The trial will include 29 patients over a period of 15 months + 24 months of follow up maximum.
The study will be conduct in womens with metastatic invasive breast cancer or locally advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line hormone therapy for metastatic breast cancer) is indicated.
The main objective of this pilot study is to evaluate the feasibility to detect in the circulating blood of patients, before treatment (T0), the presence of the fifteen tissular microRNAs described in preclinical studies as possibly involved in hormone resistance/sensitivity.
In parallel of the detection of these specific miRNAs, we will conduct a larger scale analysis of circulating miRNAs in these patients before (T = 0) and after one month of treatment (T28).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hormone therapy treatment | Experimental | Drug: Tamoxifen, Letrozole , Anastrozole, ExemestaneTamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women of more than 18 years old (menopausal or not)
- 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).
- Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (>= 10% of tumor cells by IHC technique).
- Cancer HER2 negative.
Key exclusion criteria (8 listed)
- Patient already treated with hormone therapy or not having stopped the previous adjuvant hormone therapy for at least 21 days.
- Prescription of chemotherapy and / or other targeted therapy (other than hormone therapy) for the treatment of the breast cancer
- Any previous hormone therapy for metastatic or locally advanced (without surgical project) breast cancer
- Known hypercalcaemia before miRNA dosage at T=0 requiring immediate biphosphonate therapy
- 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.
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 |
|---|---|---|
| Tamoxifen, Letrozole , Anastrozole, ExemestaneCurrent first line metastatic hormone therapy treatment in hormone dependent breast cancer : Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day | Drug | hormone therapy treatment |
Primary outcome
Rates of patients for which specific tissular miRNAs are detected in blood before treatment (D0)
Time frame: 1 time point (D0) over a period of 39 months
MiRNAs will be quantified in plasma using qPCR (quantitative Polymerase Chain Reaction) with the kit "miScriptSYBR Green PCR" (Qiagen)
4 secondary outcomes
Analysis of the larger-scale circulating miRNAs in plasma of these patients before (D0) and after one month (D28) of treatment with tamoxifen or anti aromatase
Time frame: 2 time points (D0 and D28) over a period of 39 months (3 years and 3 months)
Correlation between the specific miRNAs initial expression and the appearance of an objective response or clinical benefit of hormone therapy and the time to progression
Time frame: 39 months (3 years and 3 months)
Rate of objective responses, defined as the number of patients with a complete or partial response.
Time frame: 39 months (3 years and 3 months)
The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
Time frame: 39 months (3 years and 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 31297647Jacot W, Dalenc F, Lopez-Crapez E, Chaltiel L, Durigova A, Gros N, Lozano N, Lacaze JL, Pouderoux S, Gladieff L, Romieu G, Roche H, Filleron T, Lamy PJ. PIK3CA mutations early persistence in cell-free tumor DNA as a negative prognostic factor in metastatic breast cancer patients treated with hormonal therapy. Breast Cancer Res Treat. 2019 Oct;177(3):659-667. doi: 10.1007/s10549-019-05349-y. Epub 2019 Jul 11.
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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. This study is not recruiting at the moment.
Florence DALENCr, PhD principal investigator
Institut Claudius Regaud
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamoxifen, Letrozole , Anastrozole, Exemestane in people with Breast Cancer, run by Institut Claudius Regaud at 2 sites in France.
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 12 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: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of patients for which specific tissular miRNAs are detected in blood before treatment (D0) (time frame: 1 time point (D0) over a period of 39 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01612871, which also lists 1 linked publication.
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 14 Apr 2026.