Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

Breast Neoplasms Clinical Trial

— TAMARO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919399
• Other study ID #: 01 SEIN 03
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2009
• Last updated: June 11, 2009
• Start date: January 2002
• Est. completion date: June 2006

Study information

• Verified date: June 2009
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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. Hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Exemestane
25mg a day during 4 months
• tamoxifen
One 20 mg tablet a day started 1 week after the first Aromasine intake

Locations

Country	Name	City	State
France	CHU de Toulouse Rangueil	Toulouse
France	Institut Claudius Regaud	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Institut Claudius Regaud	PHARMACIA SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the objective response rate (complete response and partial response)		June 2006	No
Secondary	Pharmacokinetic interaction between Exemestane and Tamoxifen		june 2006	Yes