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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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Novartis:

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

Enrollment: 112
Study Start Date: March 2003
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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00237133     History of Changes
Other Study ID Numbers: CFEM345EBR01
Study First Received: October 9, 2005
Last Updated: August 6, 2012
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Novartis:
Breast cancer,
Letrozole,
Hormonal receptors

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013