Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women - Full Text View

Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women (PREDICT)

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00237133

Purpose

Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)

Condition	Intervention	Phase
Locally Advanced Breast Cancer	Drug: Letrozole	Phase IV

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)

Further study details as provided by Novartis:

Study Start Date:

March 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Postmenopausal women
Primary locally invasive breast cancer
Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells.
Post menopausal status
Tumor measurable by clinical examination, mammography and ultrasound

Exclusion Criteria

Prior treatment with letrozole or tamoxifen.
Patients with bilateral breast tumors
Patients who are eligible for breast conserving surgery
Evidence of inflammatory breast cancer or distant metastasis.
Other concurrent malignant disease
Concomitant anti-cancer treatments such as chemotherapy

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237133

Locations

Brazil
Novartis Investigative Site
Rio de Janeiro, Brazil
Novartis Investigative Site
Santo Andre, Brazil
Novartis Investigative Site
Rio de Janeiro, Brazil
Novartis Investigative Site
Porto Alegre/RS, Brazil
Novartis Investigative Site
Sao Paulo/SP, Brazil
Novartis Investigative Site
Florianopolis - SC, Brazil
Novartis Investigative Site
Ribeirao - SP, Brazil
Novartis Investigative Site
Fortaleza/CE, Brazil
Novartis Investigative Site
Barretos - SP, Brazil
Novartis Investigative Site
Goiania/GO, Brazil
Novartis Investigative Site
Jau -SP, Brazil
Novartis Investigative Site
Vitoria/ES, Brazil

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFEM345EBR01
Study First Received:	October 9, 2005
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00237133
Health Authority:	Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency

Keywords provided by Novartis:

Breast cancer
Letrozole
Hormonal receptors

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009