Breast CancerPhase 4OXYTAMNCT01553903
Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not
A Phase 4 study testing Tamoxifen,, Exemestane and Anastrozole in people with Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up. Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be… 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,, Exemestane and Anastrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to May 2013
- 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 (menopause or not).
- Women with invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained.
- Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (≥ 10% of tumor cells in Technical HIC).
- Any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry.
- WHO ≤ 2.
- Women of childbearing age must use effective contraception for the duration of the study.
- Informed consent obtained and signed before any specific procedure in the study.
- Patient member in a national insurance scheme.
Who cannot join
- Patient with breast cancer HER2 positive (IHC and / or FISH-CISH)
- Patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.
- Patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.
- Any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making 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 can not participate in the study.
- Patients under legal guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up.
Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study.
The main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen,, Exemestane, Anastrozole, Letrozole
- Keywords
- Hormonal therapy, Breast Cancer, AEBS, Oxysterols
- 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,Drug
Tamoxifen 20 mg/day during 5 years,
ExemestaneDrug
Exemestane 25mg/day during 5 years
AnastrozoleDrug
Anastrozole 1 mg/day during 5 years,
LetrozoleDrug
Letrozole 2.5 mg/day during 5 years,
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen, | Experimental | Current hormonotherapy treatment in hormone dependent breast cancer Receives: Drug: Tamoxifen, |
| Exemestane | Experimental | Current hormonotherapy treatment in hormone dependent breast cancer Receives: Drug: Exemestane |
| Anastrozole | Experimental | Current hormonotherapy treatment in hormone dependent breast cancer Receives: Drug: Anastrozole |
| Letrozole | Experimental | Current hormonotherapy treatment in hormone dependent breast cancer Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human.
Oxysterols measured are the following : OCDO (6-oxo-cholestan-3 beta, 5 alpha-diol), CE (cholesterol-5,6-eposides) and CT (cholestane-3 beta, 5 alpha, 6 beta-triol).
Calibration curve will be established for each Oxysterol by GC/MS using deuterated analogues of each oxysterols for the quantification.
Measured: 2 time points (D0 and D28) over a period of 2 years
Secondary outcomes (2)
Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with Tamoxifen
Plasma concentrations of Oxysterols evaluated by Gaz chromatography coupled to mass spectrometry (GC/MS)in patients after 28 days of hormonal therapy with Tamoxifen in order to determine the impact of the treatment on these plasmatic concentrations(D28 oxysterols plasma concentrations will be compared to D0 oxysterols plasma concentrations)
Measured: 2 time points (D0 and D28) over a period of 2 years
Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with anti-aromatase.
Plasma concentrations of Oxysterols evaluated by Gaz chromatography coupled to mass spectrometry (GC/MS)in patients after 28 days of hormonal therapy with anti-aromatase (Anastrozole, Letrozole or Exemestane) in order to determine the absence of impact of the treatment on these plasmatic concentrations (D28 oxysterols plasma concentrations will be compared to D0 oxysterols plasma concentrations).
Measured: 2 time points (D0 and D28) over a period of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2013
- Study completionMay 2013
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence DALENC, MD, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553903
- Sponsor's protocol ID
- 11 SEIN 09
- Acronym
- OXYTAM
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2011
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Dalenc F, Iuliano L, Filleron T, Zerbinati C, Voisin M, Arellano C, Chatelut E, Marquet P, Samadi M, Roche H, Poirot M, Silvente-Poirot S. Circulating oxysterol metabolites as potential new surrogate markers in patients with hormone receptor-positive breast cancer: Results of the OXYTAM study. J Steroid Biochem Mol Biol. 2017 May;169:210-218. doi: 10.1016/j.jsbmb.2016.06.010. Epub 2016 Jun 22.
PubMed 27343991
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
- Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not
- ClinicalTrials.gov ID
- NCT01553903
- Acronym / sponsor ID
- OXYTAM / 11 SEIN 09
- Conditions
- Breast Cancer
- Keywords
- Hormonal therapy, Breast Cancer, AEBS, Oxysterols
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Mar 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 study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up.
Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study.
The main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen, | Experimental | Drug: Tamoxifen,Current hormonotherapy treatment in hormone dependent breast cancer |
| Exemestane | Experimental | Drug: ExemestaneCurrent hormonotherapy treatment in hormone dependent breast cancer |
| Anastrozole | Experimental | Drug: AnastrozoleCurrent hormonotherapy treatment in hormone dependent breast cancer |
| Letrozole | Experimental | Drug: LetrozoleCurrent hormonotherapy treatment in hormone dependent breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women of more than 18 years old (menopause or not).
- Women with invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained.
- Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (≥ 10% of tumor cells in Technical HIC).
- Any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry.
- WHO ≤ 2.
Key exclusion criteria (7 listed)
- Patient with breast cancer HER2 positive (IHC and / or FISH-CISH)
- Patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.
- Patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.
- Any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making 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.
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,Tamoxifen 20 mg/day during 5 years, | Drug | Tamoxifen, |
| ExemestaneExemestane 25mg/day during 5 years | Drug | Exemestane |
| AnastrozoleAnastrozole 1 mg/day during 5 years, | Drug | Anastrozole |
| LetrozoleLetrozole 2.5 mg/day during 5 years, | Drug | Letrozole |
Primary outcome
Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human.
Time frame: 2 time points (D0 and D28) over a period of 2 years
Oxysterols measured are the following : OCDO (6-oxo-cholestan-3 beta, 5 alpha-diol), CE (cholesterol-5,6-eposides) and CT (cholestane-3 beta, 5 alpha, 6 beta-triol). Calibration curve will be established for each Oxysterol by GC/MS using deuterated analogues of each oxysterols for the quantification.
2 secondary outcomes
Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with Tamoxifen
Time frame: 2 time points (D0 and D28) over a period of 2 years
Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with anti-aromatase.
Time frame: 2 time points (D0 and D28) over a period of 2 years
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 27343991Dalenc F, Iuliano L, Filleron T, Zerbinati C, Voisin M, Arellano C, Chatelut E, Marquet P, Samadi M, Roche H, Poirot M, Silvente-Poirot S. Circulating oxysterol metabolites as potential new surrogate markers in patients with hormone receptor-positive breast cancer: Results of the OXYTAM study. J Steroid Biochem Mol Biol. 2017 May;169:210-218. doi: 10.1016/j.jsbmb.2016.06.010. Epub 2016 Jun 22.
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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 DALENC, MD principal investigator
Institut Claudius Regaud
1 site 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,, Exemestane and Anastrozole in people with Breast Cancer, run by Institut Claudius Regaud at 1 site 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 8 inclusion and 7 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 1 site 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?
Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human. (time frame: 2 time points (D0 and D28) over a period of 2 years). 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 NCT01553903, 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.