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

October 9, 2005
August 6, 2012
March 2003
January 2009   (final data collection date for primary outcome measure)
Safety and tolerability of Letrozole [ Time Frame: frequency and severity of the clinical adverse events ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00237133 on ClinicalTrials.gov Archive Site
Not Provided
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Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women
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)

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced Breast Cancer
Drug: Letrozole
1 tablet of Letrozole 2.5 mg orally adminnistered once a day
Experimental: Letrozole
Intervention: Drug: Letrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
Not Provided
January 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00237133
CFEM345EBR01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2012

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