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

February 22, 2017 updated by: Novartis Pharmaceuticals

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • 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
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Postmenopausal women
  2. Primary locally invasive breast cancer
  3. 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.
  4. Post menopausal status
  5. Tumor measurable by clinical examination, mammography and ultrasound

Exclusion Criteria:

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

Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Letrozole
Drug: Letrozole
1 tablet of Letrozole 2.5 mg orally adminnistered once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of Letrozole
Time Frame: frequency and severity of the clinical adverse events
frequency and severity of the clinical adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 21, 2009

Study Registration Dates

First Submitted

October 9, 2005

First Submitted That Met QC Criteria

October 9, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFEM345EBR01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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