NCT00919399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2002

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

4.4 years

First QC Date

June 11, 2009

Last Update Submit

June 11, 2009

Conditions

Breast Neoplasms

Keywords

breast cancerlocally advancedMenopausal patientaromasintamoxifenefficacy

Outcome Measures

Primary Outcomes (1)

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

    June 2006

Secondary Outcomes (1)

  • Pharmacokinetic interaction between Exemestane and Tamoxifen

    june 2006

Interventions

ExemestaneDRUG

25mg a day during 4 months

Also known as: AROMASINE®
tamoxifenDRUG

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

Also known as: KESSAR®

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • +5 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Toulouse Rangueil

Toulouse, France

Location

Institut Claudius Regaud

Toulouse, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestaneTamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Henri ROCHE

    Institut Claudius Regaud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 12, 2009

Study Start

January 1, 2002

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

FR(2)