Breast CancerEUTACAMNCT04740697
Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer
A study testing Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen. in people with Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer. 200 patients will be included in the study. Read more about this study
- Who is it for?
- Ages 18 months and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2021to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 months and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 years at entry into the study.
- Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
- Patients treated with tamoxifen for a maximum of 1 to 3 years.
- Patient affiliated with a Social Security system in France.
- Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
Who cannot join
- Pregnant or breastfeeding women.
- Any psychological, family, geographical or sociological condition that does not allow the medical follow-up and/or the procedures foreseen in the study protocol to be respected.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059
Florence DALENC, 05 31 15 51 04, dalenc.florence@iuct-oncopole.fr
About this study
Official title: Pilot Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer
This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer.
200 patients will be included in the study.
Each patient will be followed for one day.
- Conditions
- Breast Cancer
- Being tested
- Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
- Keywords
- Breast Cancer, Tamoxifen, Alternative and complementary therapies, Treatment adherence, Turmeric
- Medical subject headings
- Breast Neoplasms, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.Other
Each included patient will be referred to the health care staff for a blood sample:
- for the determination of the residual plasma concentration of tamoxifen and its active metabolites,
- for the constitution of a biobank.
Patients will then complete a questionnaire to collect information on tamoxifen intake and adherence (via the GIRERD questionnaire), as well as possible Alternative and Complementary Therapeutics (ACT) intake (reason for use, type of ACT, ...).
| Study group | Role | What they receive |
|---|---|---|
| Patient with localized breast cancer. | Other | Not described Receives: Other: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who adhere to tamoxifen treatment.
This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.
Measured: 18 months after the start of the research
Secondary outcomes (3)
Rate of patients taking ACT.
Measured: 18 months after the start of the research
Rate of patients consuming turmeric-based dietary supplements.
Measured: 18 months after the start of the research
Plasma concentration of tamoxifen in patients.
Measured: 18 months after the start of the research
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start12 Feb 2021
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740697
- Sponsor's protocol ID
- 20 SEIN 13
- Acronym
- EUTACAM
- Status last verified
- Apr 2026
- First submitted
- 2 Feb 2021
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04740697
- Acronym / sponsor ID
- EUTACAM / 20 SEIN 13
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Tamoxifen, Alternative and complementary therapies, Treatment adherence, Turmeric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 5 Feb 2021 (actual)
- 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 pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer.
200 patients will be included in the study.
Each patient will be followed for one day.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with localized breast cancer. | Other | Other: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen. |
Who may qualify
- Ages
- 18 months and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years at entry into the study.
- Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
- Patients treated with tamoxifen for a maximum of 1 to 3 years.
- Patient affiliated with a Social Security system in France.
- Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding women.
- Any psychological, family, geographical or sociological condition that does not allow the medical follow-up and/or the procedures foreseen in the study protocol to be respected.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
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 |
|---|---|---|
| Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.Each included patient will be referred to the health care staff for a blood sample: * for the determination of the residual plasma concentration of tamoxifen and its active metabolites, * for the constitution of a biobank. Patients will then complete a questionnaire to collect information on tamoxifen intake and adherence (via the GIRERD questionnaire), as well as possible Alternative and Complementary Therapeutics (ACT) intake (reason for use, type of ACT, ...). | Other | Patient with localized breast cancer. |
Primary outcome
Rate of patients who adhere to tamoxifen treatment.
Time frame: 18 months after the start of the research
This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.
3 secondary outcomes
Rate of patients taking ACT.
Time frame: 18 months after the start of the research
Rate of patients consuming turmeric-based dietary supplements.
Time frame: 18 months after the start of the research
Plasma concentration of tamoxifen in patients.
Time frame: 18 months after the start of the research
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen. 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence DALENC (05 31 15 51 04, dalenc.florence@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who adhere to tamoxifen treatment. (time frame: 18 months after the start of the research). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.