Hormono-depending Adjuvant Breast CancerPhase 4PHACSNCT01127295
Pharmacology of Adjuvant Hormonotherapy in Breast Cancer
A Phase 4 study testing Tamoxifen, Letrozole, Anastrozole or Exemestane in people with Hormono-depending Adjuvant Breast Cancer, run by Institut Claudius Regaud at 24 sites in France.
Trial summary
This is a biomedical study of interventional type, multicenter, inter-regional. Patients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormono-depending Adjuvant Breast Cancer
- What is being tested?
- Tamoxifen, Letrozole, Anastrozole or Exemestane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 24 sitesFrance
- Study dates
- 17 Jun 2010to 1 Dec 2017
- 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
- Patient of more than 18 years old (menopaused or not)
- Invasive breast cancer non-metastatic locally controlled by surgery with or without radiotherapy. Previous treatment with chemotherapy is allowed including trastuzumab
- Cancer hormone-expressing ER and / or PR (> 10% tumor cells in Technical HIC)
- Having a staging exploring bone, liver, lung and showing no abnormality secondary (for sub-centimeter tumors, the staging is not necessary)
- WHO <2
- Before the initiation of adjuvant hormonal therapy (tamoxifen, anastrozole, letrozole or exemestane) and whatever the approach chosen by the investigator (5 years of tamoxifen, 5 years of anti-aromatase or sequential patterns)
- signed Consent collected before any specific procedure in the study
- Patient member in a national insurance scheme.
Who cannot join
- Patient previously treated for breast cancer receiving hormonal therapy with tamoxifen, anastrozole, letrozole or exemestane regardless of the scheme
- Metastatic Breast cancer
- History of another cancer diagnosed within 5 years before or uncontrolled except carcinoma in situ of cervix carcinoma, nonmelanoma skin, breast cancer (in this case, treatment with hormone therapy should be stopped for at least 6 months)
- 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
- Women of childbearing age must use effective contraception at study entry and up to at least three months after the end of treatment
- Patient under legal guardianship
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Clinique Calabet
Agen, 47000
Clinique Claude Bernard
Albi, 81030
Centre Hospitalier d'Auch
Auch, 32008
CHU de Bordeaux
Bordeaux, 33000
Clinique Tivoli
Bordeaux, 33000
Institut Bergonié
Bordeaux, 33076
Polyclinique Bordeaux Nord
Bordeaux, 33077
Centre Hospitalier de Brive
Brive-la-Gaillarde, 19312
Centre Hospitalier de Cahors
Cahors, 46005
Centre Hospitalier Intercommunal de Castres-Mazamet
Castres, 81108
Hôpital Dupuytren CHU Limoges
Limoges, 87042
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan, 40024
Centre Hospitalier de Montauban
Montauban, 82013
Centre Val d'Aurelle
Montpellier, 34298
Hôpital Caremeau CHU Nîmes
Nîmes, 30029
Centre Hospitalier de Pau
Pau, 64000
Centre Catalan d'Oncologie
Perpignan, 66000
Centre Hospitalier de Rodez
Rodez, 12000
Polyclinique de l'Ormeau
Tarbes, 65000
Claudius Regaud
Toulouse, 31052
CHU de Rangueil
Toulouse, 31059
Clinique Pasteur - Département d'Oncologie Médicale
Toulouse, 31076
Clinique Pasteur - Département de Radiothérapie
Toulouse, 31300
Clinique Saint-Jean du Languedoc
Toulouse, 31400
About this study
Official title: Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer
This is a biomedical study of interventional type, multicenter, inter-regional.
Patients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. The main objective is to estimate the correlations between pharmacokinetic and pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3 years.
- Conditions
- Hormono-depending Adjuvant Breast Cancer
- Being tested
- Tamoxifen, Letrozole, Anastrozole or Exemestane
- Keywords
- Pharmacokinetics, Pharmacogenetic, tamoxifen, anti-aromatases, breast cancer, pharmacodynamy, Observance
- 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 or ExemestaneDrug
Tamoxifen 20 mg/day during 5 years Létrozole 2.5 mg/day during 5 years Anastrozole 1 mg/day during 5 years Exémestane 25 mg/day during 5 years
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen, Anastrozole, letrozole, Exemestane | Other | Current hormonotherapy treatment in hormono dependent breast cancer Receives: Drug: Tamoxifen, Letrozole, Anastrozole or Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between pharmacokinetic and pharmacogenetic parameters
To estimate the correlations between pharmacokinetic and pharmacogenetic parameters of hormonal adjuvant breast cancer treatment during the first 3 years.
Measured: 9 years
Secondary outcomes (5)
To estimate the relation between plasmatic concentrations, pharmacogenetic characteristic and adverse effects.
Measured: 9 years
To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment
Measured: 9 years
To estimate the link between plasmatic concentrations and the premature relapse (in the first 3 years)
Measured: 9 years
To estimate the declared therapeutic observance to the real exposure at the treatment measured by plasmatic concentrations.
Measured: 9 years
appearance auto-antibody and correlate to the clinical data
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study start17 Jun 2010
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hormono-depending Adjuvant 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henri ROCHE, Pr, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127295
- Sponsor's protocol ID
- 09 SEIN 09
- Acronym
- PHACS
- Status last verified
- Apr 2026
- First submitted
- 18 May 2010
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puszkiel A, Arellano C, Vachoux C, Evrard A, Le Morvan V, Boyer JC, Robert J, Delmas C, Dalenc F, Debled M, Venat-Bouvet L, Jacot W, Suc E, Sillet-Bach I, Filleron T, Roche H, Chatelut E, White-Koning M, Thomas F. Factors Affecting Tamoxifen Metabolism in Patients With Breast Cancer: Preliminary Results of the French PHACS Study. Clin Pharmacol Ther. 2019 Sep;106(3):585-595. doi: 10.1002/cpt.1404. Epub 2019 Apr 10.
PubMed 30786012Puszkiel A, Arellano C, Vachoux C, Evrard A, Le Morvan V, Boyer JC, Robert J, Delmas C, Dalenc F, Debled M, Venat-Bouvet L, Jacot W, Dohollou N, Bernard-Marty C, Laharie-Mineur H, Filleron T, Roche H, Chatelut E, Thomas F, White-Koning M. Model-Based Quantification of Impact of Genetic Polymorphisms and Co-Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer. Clin Pharmacol Ther. 2021 May;109(5):1244-1255. doi: 10.1002/cpt.2077. Epub 2020 Nov 10.
PubMed 33047329Puszkiel A, Dalenc F, Tafzi N, Marquet P, Debled M, Jacot W, Venat-Bouvet L, Ferrer C, Levasseur N, Paulon R, Dauba J, Evrard A, Mauries V, Filleron T, Chatelut E, Thomas F, White-Koning M. Identification of non-adherence to adjuvant letrozole using a population pharmacokinetics approach in hormone receptor-positive breast cancer patients. Eur J Pharm Sci. 2024 Aug 1;199:106809. doi: 10.1016/j.ejps.2024.106809. Epub 2024 May 22.
PubMed 38788907
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
- Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT01127295
- Acronym / sponsor ID
- PHACS / 09 SEIN 09
- Conditions
- Hormono-depending Adjuvant Breast Cancer
- Keywords
- Pharmacokinetics, Pharmacogenetic, tamoxifen, anti-aromatases, breast cancer, pharmacodynamy, Observance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 17 Jun 2010 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 20 May 2010 (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, multicenter, inter-regional.
Patients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. The main objective is to estimate the correlations between pharmacokinetic and pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen, Anastrozole, letrozole, Exemestane | Other | Drug: Tamoxifen, Letrozole, Anastrozole or ExemestaneCurrent hormonotherapy treatment in hormono 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)
- Patient of more than 18 years old (menopaused or not)
- Invasive breast cancer non-metastatic locally controlled by surgery with or without radiotherapy. Previous treatment with chemotherapy is allowed including trastuzumab
- Cancer hormone-expressing ER and / or PR (> 10% tumor cells in Technical HIC)
- Having a staging exploring bone, liver, lung and showing no abnormality secondary (for sub-centimeter tumors, the staging is not necessary)
- WHO <2
Key exclusion criteria (8 listed)
- Patient previously treated for breast cancer receiving hormonal therapy with tamoxifen, anastrozole, letrozole or exemestane regardless of the scheme
- Metastatic Breast cancer
- History of another cancer diagnosed within 5 years before or uncontrolled except carcinoma in situ of cervix carcinoma, nonmelanoma skin, breast cancer (in this case, treatment with hormone therapy should be stopped for at least 6 months)
- 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, Letrozole, Anastrozole or ExemestaneTamoxifen 20 mg/day during 5 years Létrozole 2.5 mg/day during 5 years Anastrozole 1 mg/day during 5 years Exémestane 25 mg/day during 5 years | Drug | Tamoxifen, Anastrozole, letrozole, Exemestane |
Primary outcome
Correlation between pharmacokinetic and pharmacogenetic parameters
Time frame: 9 years
To estimate the correlations between pharmacokinetic and pharmacogenetic parameters of hormonal adjuvant breast cancer treatment during the first 3 years.
5 secondary outcomes
To estimate the relation between plasmatic concentrations, pharmacogenetic characteristic and adverse effects.
Time frame: 9 years
To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment
Time frame: 9 years
To estimate the link between plasmatic concentrations and the premature relapse (in the first 3 years)
Time frame: 9 years
To estimate the declared therapeutic observance to the real exposure at the treatment measured by plasmatic concentrations.
Time frame: 9 years
appearance auto-antibody and correlate to the clinical data
Time frame: 9 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 30786012Puszkiel A, Arellano C, Vachoux C, Evrard A, Le Morvan V, Boyer JC, Robert J, Delmas C, Dalenc F, Debled M, Venat-Bouvet L, Jacot W, Suc E, Sillet-Bach I, Filleron T, Roche H, Chatelut E, White-Koning M, Thomas F. Factors Affecting Tamoxifen Metabolism in Patients With Breast Cancer: Preliminary Results of the French PHACS Study. Clin Pharmacol Ther. 2019 Sep;106(3):585-595. doi: 10.1002/cpt.1404. Epub 2019 Apr 10.
- Results publication: PubMed 33047329Puszkiel A, Arellano C, Vachoux C, Evrard A, Le Morvan V, Boyer JC, Robert J, Delmas C, Dalenc F, Debled M, Venat-Bouvet L, Jacot W, Dohollou N, Bernard-Marty C, Laharie-Mineur H, Filleron T, Roche H, Chatelut E, Thomas F, White-Koning M. Model-Based Quantification of Impact of Genetic Polymorphisms and Co-Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer. Clin Pharmacol Ther. 2021 May;109(5):1244-1255. doi: 10.1002/cpt.2077. Epub 2020 Nov 10.
- Results publication: PubMed 38788907Puszkiel A, Dalenc F, Tafzi N, Marquet P, Debled M, Jacot W, Venat-Bouvet L, Ferrer C, Levasseur N, Paulon R, Dauba J, Evrard A, Mauries V, Filleron T, Chatelut E, Thomas F, White-Koning M. Identification of non-adherence to adjuvant letrozole using a population pharmacokinetics approach in hormone receptor-positive breast cancer patients. Eur J Pharm Sci. 2024 Aug 1;199:106809. doi: 10.1016/j.ejps.2024.106809. Epub 2024 May 22.
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.
Henri ROCHE, Pr principal investigator
Institut Claudius Regaud
24 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 or Exemestane in people with Hormono-depending Adjuvant Breast Cancer, run by Institut Claudius Regaud at 24 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 8 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 24 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?
Correlation between pharmacokinetic and pharmacogenetic parameters (time frame: 9 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 NCT01127295, which also lists 3 linked publications.
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; AzTrials last refreshed its copy on 8 Nov 2026.