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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

June 11, 2009
June 11, 2009
January 2002
June 2006   (final data collection date for primary outcome measure)
Evaluate the objective response rate (complete response and partial response) [ Time Frame: June 2006 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Pharmacokinetic interaction between Exemestane and Tamoxifen [ Time Frame: june 2006 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
  • 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®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2006
June 2006   (final data collection date for primary outcome measure)

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
Female
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00919399
01 SEIN 03
No
Henri Roché - Professor, Institut Claudius Regaud
Institut Claudius Regaud
PHARMACIA SAS
Principal Investigator: Henri ROCHE Institut Claudius Regaud
Institut Claudius Regaud
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP