N/A
N=10
Pre-Surgical Intervention for Targeted Therapies for Breast Cancer
Invasive Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01004744 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery — 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anastrozole (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery |
10 | — |
Summary
The purpose of this study is to determine the feasibility of a short term administration of a targeted therapy (i.e., anastrozole) in women with newly diagnosed early invasive or non invasive breast cancer during the interval between their breast biopsy and surgery. Anastrozole is a form of hormonal therapy which is part of the standard treatment for hormone sensitive breast cancer in postmenopausal women. This clinical model is being used to evaluate the biologic effects of this drug on a specific molecular pathway called the PI3K/AKT signaling pathway.
Eligibility Criteria
Inclusion Criteria
- Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
- Postmenopausal status defined as cessation of menses for >1 year or FSH > 20 mIU/mL (within the past month)
- Age ≥ 21 years
- No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
- Signed informed consent
Exclusion Criteria
- Treatment with other investigational drugs within 6 months of study entry
- Other serious intercurrent medical illness
Data sourced from ClinicalTrials.gov (NCT01004744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.