Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

Phase 2

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT00919399
• Lead Sponsor: Institut Claudius Regaud

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2009-06
• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Last Update Submitted: 2009-06-11
• Study First Posted: 2009-06-12
• Last Update Posted: 2009-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate the objective response rate (complete response and partial response)	June 2006

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic interaction between Exemestane and Tamoxifen	june 2006

Trial Locations

Locations (2)

CHU de Toulouse Rangueil; 🇫🇷 Toulouse, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France