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OpenTrials
Completed

NCT Number: NCT00237133

Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

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)

Completed

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Key information

Conditions

Locally Advanced Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Barretos - SP, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

letrozole

Drug

1 tablet of Letrozole 2.5 mg orally adminnistered once a day

Primary outcomes

  1. Safety and tolerability of Letrozole

    Time frame: frequency and severity of the clinical adverse events

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)

Acronym: PREDICT

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Oct 12, 2005
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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