Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women (PREDICT)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00237133
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
| Responsible Party: | 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 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 |
ClinicalTrials.gov processed this record on September 29, 2016