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

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ClinicalTrials.gov Identifier: NCT00237133
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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)

Condition or disease Intervention/treatment Phase
Locally Advanced Breast Cancer Drug: Letrozole Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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)
Study Start Date : March 2003
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 21, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Letrozole Drug: Letrozole
1 tablet of Letrozole 2.5 mg orally adminnistered once a day


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of Letrozole [ Time Frame: frequency and severity of the clinical adverse events ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 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