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
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:
- 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.
For general information, see Learn About Clinical Studies.
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
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 Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Letrozole |
Antineoplastic Agents Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015