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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


Phase 2
60 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the objective response rate (complete response and partial response)

Outcome Time Frame:

June 2006

Safety Issue:

No

Principal Investigator

Henri ROCHE

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

01 SEIN 03

NCT ID:

NCT00919399

Start Date:

January 2002

Completion Date:

June 2006

Related Keywords:

  • Breast Neoplasms
  • breast cancer
  • locally advanced
  • Menopausal patient
  • aromasin
  • tamoxifen
  • efficacy
  • Breast Neoplasms
  • Neoplasms

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