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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00237133

First received: October 9, 2005

Last updated: February 22, 2017

Last verified: February 2017

History of Changes

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 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Letrozole

U.S. FDA Resources

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:

Safety and tolerability of Letrozole [ Time Frame: frequency and severity of the clinical adverse events ]


Enrollment:	112
Study Start Date:	March 2003
Study Completion Date:	January 21, 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Letrozole	Drug: Letrozole 1 tablet of Letrozole 2.5 mg orally adminnistered once a day

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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: NCT00237133

Locations


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

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Additional Information:

Results for CFEM345EBR01 from the Novartis Clinical Trials website This link exits the ClinicalTrials.gov site


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00237133 History of Changes
Other Study ID Numbers:	CFEM345EBR01
Study First Received:	October 9, 2005
Last Updated:	February 22, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Breast cancer, Letrozole, Hormonal receptors

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Antineoplastic Agents Aromatase Inhibitors	Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 22, 2017

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