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Completed

NCT Number: NCT00919399

Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

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.

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Key information

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Toulouse Rangueil, Toulouse, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exemestane

Drug

25mg a day during 4 months

Other names: AROMASINE®

Tamoxifen

Drug

One 20 mg tablet a day started 1 week after the first Aromasine intake

Other names: KESSAR®

Primary outcomes

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

    Time frame: June 2006

Secondary outcomes

  1. Pharmacokinetic interaction between Exemestane and Tamoxifen

    Time frame: june 2006

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • PHARMACIA SAS

Registry information

Official study 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

Acronym: TAMARO

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Jun 12, 2009
Registry last updated
Jun 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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