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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 9, 2005
Last updated: August 6, 2012
Last verified: August 2012
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:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00237133

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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) 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,
Hormonal receptors

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 04, 2016