Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant (TAMARO)

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Tamoxifen
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014