Status:
COMPLETED
Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women
Lead Sponsor:
Rita Sanghvi, Mehta
Collaborating Sponsors:
AstraZeneca
Conditions:
DCIS
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Breast cancer is one of the most common cancers seriously afflicting women in the United States. Of the one million incident cases that are reported annually there are approximately 193,000 new cases ...
Detailed Description
Specific Aim 1: We hypothesize that a proliferative marker Ki-67 is reduced in patients with preinvasive Ductal Carcinoma In Situ (DCIS) and very early breast cancer treated with anastrozole. To estab...
Eligibility Criteria
Inclusion
- Patients must have suspicion of DCIS or early invasive breast cancer on mammography.
- Patients must have histologically confirmed diagnosis of DCIS or early invasive breast cancer on core biopsy for final registration.
- Patients must be over 18 years of age
- "Patients must be postmenopausal as defined by one of the following criteria:
- Prior bilateral oophorectomy OR
- \> 12 months since LMP with no prior hysterectomy OR
- a \& b not applicable AND age \>=50
- Patients must be positive for either ER or PR or both
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion
- Patients must not have diagnosis of osteoporosis (T-score -2.5 according to the WHO)
Key Trial Info
Start Date :
September 21 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2018
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00256217
Start Date
September 21 2004
End Date
December 12 2018
Last Update
May 11 2021
Active Locations (1)
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1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868