Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women (PREDICT)
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ClinicalTrials.gov Identifier: NCT00237133 |
Recruitment Status
:
Completed
First Posted
: October 12, 2005
Last Update Posted
: February 24, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Locally Advanced Breast Cancer | Drug: Letrozole | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 112 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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) |
Study Start Date : | March 2003 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | January 21, 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Letrozole |
Drug: Letrozole
1 tablet of Letrozole 2.5 mg orally adminnistered once a day
|
- Safety and tolerability of Letrozole [ Time Frame: frequency and severity of the clinical adverse events ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237133
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Additional Information:
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00237133 History of Changes |
Other Study ID Numbers: |
CFEM345EBR01 |
First Posted: | October 12, 2005 Key Record Dates |
Last Update Posted: | February 24, 2017 |
Last Verified: | February 2017 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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 |