Breast NeoplasmsPhase 2TAMARONCT00919399
Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant
A Phase 2 study testing Exemestane and tamoxifen in people with Breast Neoplasms, run by Institut Claudius Regaud at 2 sites in France.
Trial summary
This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Exemestane and tamoxifen
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2002to Jun 2006
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer histologically proven by a 14 G or 16 G micro-biopsy to have confirmation of the diagnosis, evaluation histology prognosis grade, hormone receptors and to obtain a sample for the study of biological factors.
- Menopausal patients as defined as follows:
- Natural menopause >= 1 year, or
- Surgical ovariectomy.
- T unilateral tumor> 3 cm, N 1-2, M0 or M +, non-inflammatory.
- Hormone receptor positive. RE positive or PR positive with histochemical technique (+ 10% of cells express the receptor)
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- No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. Discontinuation of replacement therapy of menopause for at least 1 month
- Age>= 60 years
- Evaluable disease
- Performance Status <= 2
- Biological function using the following criteria:
- neutrophils >= 2.10E9 / l,
- Platelets> = 100.10E9 / l,
- Hemoglobin> = 10 g / dl,
- Creatinine <= 1.5 x upper normal,
- Total bilirubin <= 1.25 x the upper normal
- Transaminases (AST and ALT) <= 1.5 x upper normal,
- Alkaline phosphatase <= 2.5 x upper normal.
- Cardiac Function: electrocardiogram (ECG) normal.
- Signed written consent before any procedure related to the study.
Who cannot join
- Men
- Non Menopausal Patients
- Patients with hormone receptor negative: PR- and RE -
- Contra-indication to anti-estrogens (risk thrombi arteria)
- Tumor <3 cm operable
- Tumor inflammatory T4d (PEV 2 or 3).
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- Extensive hepatic lesions (> 1 / 3 of liver volume)
- Uncontrolled cardiac disease such as angina, congestive heart failure, or arrhythmia requiring medical treatment or history of myocardial infarction within 3 months before.
- History of cancer except skin cancer and basal cell cancer in situ of the cervix (a contralateral breast cancer had been no systemic treatment will be admitted).
- Chronic diseases (somatic or psychiatric) in poor prognosis.
- Patients who for reasons of family, social, geographical or psychological can not be followed properly.
- Patients under law protection
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Toulouse Rangueil
Toulouse
Institut Claudius Regaud
Toulouse
About this study
Official title: Phase II Study Evaluating the Effectiveness of the Exemestane (Aromasin) With Tamoxifen on the Rate of Clinical Response Menopausal in Patients With Locally Advanced Breast Tumors
This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.
- Conditions
- Breast Neoplasms
- Being tested
- Exemestane, tamoxifen
- Keywords
- breast cancer, locally advanced, Menopausal patient, aromasin, tamoxifen, efficacy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExemestaneDrug
Also called AROMASINE®
25mg a day during 4 months
tamoxifenDrug
Also called KESSAR®
One 20 mg tablet a day started 1 week after the first Aromasine intake
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the objective response rate (complete response and partial response)
Measured: June 2006
Secondary outcomes (1)
Pharmacokinetic interaction between Exemestane and Tamoxifen
Measured: june 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJan 2002
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- PHARMACIA SAS
- Investigators
- Henri ROCHE, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919399
- Sponsor's protocol ID
- 01 SEIN 03
- Acronym
- TAMARO
- Status last verified
- Jun 2009
- First submitted
- 11 Jun 2009
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Effectiveness of the Exemestane (Aromasin) With Tamoxifen on the Rate of Clinical Response Menopausal in Patients With Locally Advanced Breast Tumors
- ClinicalTrials.gov ID
- NCT00919399
- Acronym / sponsor ID
- TAMARO / 01 SEIN 03
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, locally advanced, Menopausal patient, aromasin, tamoxifen, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- PHARMACIA SAS
- Study start
- Jan 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 12 Jun 2009 (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 Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Breast cancer histologically proven by a 14 G or 16 G micro-biopsy to have confirmation of the diagnosis, evaluation histology prognosis grade, hormone receptors and to obtain a sample for the study of biological factors.
- Menopausal patients as defined as follows:
- T unilateral tumor> 3 cm, N 1-2, M0 or M +, non-inflammatory.
- Hormone receptor positive. RE positive or PR positive with histochemical technique (+ 10% of cells express the receptor)
- No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. Discontinuation of replacement therapy of menopause for at least 1 month
Key exclusion criteria (12 listed)
- Men
- Non Menopausal Patients
- Patients with hormone receptor negative: PR- and RE -
- Contra-indication to anti-estrogens (risk thrombi arteria)
- Tumor <3 cm operable
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 |
|---|---|---|
| ExemestaneAlso: AROMASINE®25mg a day during 4 months | Drug | – |
| tamoxifenAlso: KESSAR®One 20 mg tablet a day started 1 week after the first Aromasine intake | Drug | – |
Primary outcome
Evaluate the objective response rate (complete response and partial response)
Time frame: June 2006
1 secondary outcome
Pharmacokinetic interaction between Exemestane and Tamoxifen
Time frame: june 2006
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 Jun 2009.
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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.
Henri ROCHE 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 2 study testing Exemestane and tamoxifen in people with Breast Neoplasms, 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 20 inclusion and 12 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 Jun 2009. 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 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 objective response rate (complete response and partial response) (time frame: June 2006). 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 Jun 2009.