Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant (TAMARO)
This study has been completed.
Sponsor:
Institut Claudius Regaud
Collaborator:
PHARMACIA SAS
Information provided by:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00919399
First received: June 11, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: Exemestane Drug: tamoxifen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Institut Claudius Regaud:
Primary Outcome Measures:
- Evaluate the objective response rate (complete response and partial response) [ Time Frame: June 2006 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic interaction between Exemestane and Tamoxifen [ Time Frame: june 2006 ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | January 2002 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Exemestane
25mg a day during 4 months
Other Name: AROMASINE®
Drug: tamoxifen
One 20 mg tablet a day started 1 week after the first Aromasine intake
Other Name: KESSAR®
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
- 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.
Exclusion Criteria:
- 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).
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919399
Locations
| France | |
| Institut Claudius Regaud | |
| Toulouse, France | |
| CHU de Toulouse Rangueil | |
| Toulouse, France | |
Sponsors and Collaborators
Institut Claudius Regaud
PHARMACIA SAS
Investigators
| Principal Investigator: | Henri ROCHE | Institut Claudius Regaud |
More Information
No publications provided
| Responsible Party: | Henri Roché - Professor, Institut Claudius Regaud |
| ClinicalTrials.gov Identifier: | NCT00919399 History of Changes |
| Other Study ID Numbers: | 01 SEIN 03 |
| Study First Received: | June 11, 2009 |
| Last Updated: | June 11, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut Claudius Regaud:
|
breast cancer locally advanced Menopausal patient |
aromasin tamoxifen efficacy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Tamoxifen Exemestane Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013