Non Metastatic Breast CancerPhase 2TAMNCT01220076
Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+
A Phase 2 study testing tamoxifen in people with Non Metastatic Breast Cancer, run by Institut Cancerologie de l'Ouest at 3 sites in France.
Trial summary
The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +. The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non Metastatic Breast Cancer
- What is being tested?
- tamoxifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2009to Oct 2016
- Phase
- Phase 2
- 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
- Adult Females (≥ 18 years), with effective contraception. The contraceptive should not use estrogen to a derivative. It must be continued during treatment with tamoxifen for at least two months after his arrest.
- Histologically confirmed diagnosis of invasive breast cancer, previously untreated. Patients have been supported for a breast cancer may be included if a period of at least 2 years between the last systemic treatment of inclusion in the study.
- Primary tumor hormonopositive: ER and / or PR ≥ 50% by immunohistochemistry.
- Lack of HER2 overexpression
- Palpable primary tumor or greater than or equal to 20 mm in diameter, measured by ultrasound
- Patient scheduled to undergo breast cancer surgery
Show all 33Show fewer
- No metastases
- Clinical Stage M0
- Performance index ≤ 1 (OMS)
- Neutrophils WBC > or = 1500 / mm3, Platelets > or = 100 000/mm3 Hemoglobin ≥10 g/dL
- Normal liver function: bilirubin ≤ 1.5 x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases).
- Normal renal function (creatinine ≤ 1.5 mg / dL or creatinine clearance ≥ 60 mL / min)
- Cardiac function (MUGA scan or ultrasound February> 55%) and lung function, 5.2.2 Criteria related to participation in the study:
- Patient affiliated to social security, Patient has signed and dated consent
- Non-Inclusion Criteria:
- Pregnant or Breastfeeding women
- Use of St. John's Wort (herbal tea ...) within 5 days before starting treatment
- Consumption of grapefruit juice in the last 5 days of starting treatment
- Congenital galactosemia
- Glucose and galactose malabsorption
- Lactase deficiency
- Co-medications that may interfere with cytochrome P450:
- Ongoing Enzyme inducers:
- Antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
- Antinfectieux: rifampin, rifabutin, névrirapine, griséofilvine, efavirenz
- Ongoing Enzyme Inhibitors:
- Inhibitors of serotonin reuptake: fluoxetine, paroxetine
- Thioridazine. Quinidine
- Amiodarone
- Ca antagonists: diltiazem, verapamil
- azole antifungals ketoconazole, fluconazole, miconazole.
- No protease inhibitors: ritonavir, nelfinavir, amprenavir, indinavir.
- Macrolides: erythromycin, clarithromycin, josamycin
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Léon Berard
Lyon, 69000
Institut Curie
Paris
Institut de Cancerologie de l'Ouest (ICO)
Saint-Herblain, 44805
About this study
Official title: Phase II Study Evaluating According to the Polymorphism of CYP2D6, the Rate of Biological Response to Treatment With Tamoxifen (TAM) Administered in Pre-operative Situation in Patients With Breast Cancer Non Metastatic HR+
The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +.
The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied.
- Conditions
- Non Metastatic Breast Cancer
- Being tested
- tamoxifen
- Keywords
- Tamoxifen,, Breat Cancer, Pharmacogenetic, non metastatic breast cancer, HR +
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamoxifenDrug
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifene | Experimental | Not described Receives: Drug: tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer
The primary endpoint is the determination of the variation in the KI-67 expression, a marker of cell proliferation, at the tumour level between the initial biopsy (T0) and after 5 weeks of tamoxifen treatment, in relation to cytochrome 2D6 polymorphisms. A 50% geometric reduction in KI-67 expression at 5 to 7 weeks should be considered as a major response
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Metastatic 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 2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220076
- Sponsor's protocol ID
- BRD 08/11-A
- Acronym
- TAM
- Status last verified
- Mar 2021
- First submitted
- 11 Oct 2010
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating According to the Polymorphism of CYP2D6, the Rate of Biological Response to Treatment With Tamoxifen (TAM) Administered in Pre-operative Situation in Patients With Breast Cancer Non Metastatic HR+
- ClinicalTrials.gov ID
- NCT01220076
- Acronym / sponsor ID
- TAM / BRD 08/11-A
- Conditions
- Non Metastatic Breast Cancer
- Keywords
- Tamoxifen,, Breat Cancer, Pharmacogenetic, non metastatic breast cancer, HR +
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Oct 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.
The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +.
The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamoxifene | Experimental | Drug: tamoxifen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Adult Females (≥ 18 years), with effective contraception. The contraceptive should not use estrogen to a derivative. It must be continued during treatment with tamoxifen for at least two months after his arrest.
- Histologically confirmed diagnosis of invasive breast cancer, previously untreated. Patients have been supported for a breast cancer may be included if a period of at least 2 years between the last systemic treatment of inclusion in the study.
- Primary tumor hormonopositive: ER and / or PR ≥ 50% by immunohistochemistry.
- Lack of HER2 overexpression
- Palpable primary tumor or greater than or equal to 20 mm in diameter, measured by ultrasound
Key exclusion criteria (0 listed)
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 | Drug | Tamoxifene |
Primary outcome
Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer
Time frame: 5 weeks
The primary endpoint is the determination of the variation in the KI-67 expression, a marker of cell proliferation, at the tumour level between the initial biopsy (T0) and after 5 weeks of tamoxifen treatment, in relation to cytochrome 2D6 polymorphisms. A 50% geometric reduction in KI-67 expression at 5 to 7 weeks should be considered as a major response
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 12 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tamoxifen in people with Non Metastatic Breast Cancer, run by Institut Cancerologie de l'Ouest at 3 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 33 inclusion and 0 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer (time frame: 5 weeks). 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 12 Mar 2021.