Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
| City: |
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Paris |
| State: |
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Texas |
| Zip Code: |
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75460 |
| Conditions: |
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Metastatic Breast Cancer |
| Purpose: |
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The purpose of this study is to find out what effect the combination of letrozole (brand
name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared
to letrozole alone
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable
locally recurrent or metastatic disease
- Has measurable or evaluable-only disease
- Is female, ≥18 yrs of age, post menopausal or surgically sterile
- HER2 negative, HR+, ER+ and/or PgR+ breast cancer
- 0-1 prior chemotherapy regimen for metastatic disease.
- Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
- Prior tamoxifen therapy is allowed
- No AI therapy for >1 year without recurrence
Exclusion Criteria:
- Pregnant or breast feeding
- Prior hormonal therapy for metastatic or locally recurrent disease
- >1 chemotherapy regimen for metastatic disease
- Pleural or pericardial effusion
- Serious cardiac condition
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| NCT ID: |
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NCT00696072 |
| Primary Contact: |
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Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb
For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email: Clinical.Trials@bms.com
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| Backup Contact: |
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First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
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| Location Contact: |
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Paris, Texas 75460
United States
Site 015
Site Status: Not yet recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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