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: August 6, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 9, 2005

Last Updated Date

August 6, 2012

Start Date ^ICMJE

March 2003

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of Letrozole [ Time Frame: frequency and severity of the clinical adverse events ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00237133 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

Official Title ^ICMJE

PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)

Brief Summary

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)

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Locally Advanced Breast Cancer

Intervention ^ICMJE

Drug: Letrozole

1 tablet of Letrozole 2.5 mg orally adminnistered once a day

Study Arm (s)

Experimental: Letrozole

Intervention: Drug: Letrozole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

112

Completion Date

Not Provided

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00237133

Other Study ID Numbers ^ICMJE

CFEM345EBR01

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

August 2012

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

To Top