Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women
PREDICT
PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)
1 other identifier
interventional
112
1 country
11
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2003
Longer than P75 for phase_4
11 active sites
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
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 9, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2009
CompletedFebruary 24, 2017
February 1, 2017
5.8 years
October 9, 2005
February 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of Letrozole
frequency and severity of the clinical adverse events
Study Arms (1)
Letrozole
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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 André, Brazil
Novartis Investigative Site
Sao Paulo/SP, Brazil
Novartis Investigative Site
Vitoria/ES, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2005
First Posted
October 12, 2005
Study Start
March 1, 2003
Primary Completion
January 1, 2009
Study Completion
January 21, 2009
Last Updated
February 24, 2017
Record last verified: 2017-02