Clinical trial NCT00919399: Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: breast cancer
locally advanced
Menopausal patient
aromasin
tamoxifen
efficacy
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
Collaborators: name: PHARMACIA SAS
First posted: 2009-06-12
Enrollment: 15
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Evaluate the objective response rate (complete response and partial response)
timeFrame: June 2006
Secondary outcomes:
measure: Pharmacokinetic interaction between Exemestane and Tamoxifen
timeFrame: june 2006
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse Rangueil
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Claudius Regaud
name: Henri ROCHE
role: PRINCIPAL_INVESTIGATOR
References: