- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01004744
Pre-Surgical Intervention for Targeted Therapies for Breast Cancer
Feasibility of Pre-Surgical Intervention Studies for Evaluating Targeted Therapies for Breast Cancer
Study Overview
Detailed Description
Several clinical models are being explored for use in the phase I/II evaluation of targeted therapies for breast cancer. Biological markers can be measured in early stage invasive cancers in a presurgical model involving a short term intervention. In this model, women with newly diagnosed early invasive breast cancer receive a study drug during the interval between diagnostic breast biopsy and surgical resection. Tumor tissue obtained from the biopsy and surgical specimens are used to measure pre and post treatment molecular markers, respectively. The main advantages of this model include the ability to obtain direct information on molecular response in tumor tissue and elucidate drug mechanisms of action, the large patient population to draw from with early stage breast cancer, and the lack of unnecessary invasive procedures.
We plan to conduct a pilot study of 10 postmenopausal women with newly diagnosed estrogen receptor (ER) positive invasive or non invasive breast cancer who will receive oral anastrozole 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery. Patients will be identified by the breast surgeon or mammographer performing the breast biopsy. Patients with histologically confirmed ER+ invasive or non invasive breast cancer will be recruited by the medical oncologist and will start anastrozole two weeks prior to their scheduled surgery. The primary objective of this study is to demonstrate the feasibility of this presurgical model for evaluating targeted therapies for breast cancer. Secondary endpoints include changes in tissue levels of the proliferation marker Ki67 and proteins involved in PI3K/AKT signaling.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Presurgical oral anastrozole
1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.
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1mg PO daily for two weeks prior to scheduled surgery
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery
Time Frame: Two weeks
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The number of subjects who complete oral anastrozole for the length of the study is analyzed.
The subjects receive oral anastrozole 1mg daily for two weeks in the interval between the biopsy and the surgery.
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Two weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine Crew, MD, Columbia University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Anastrozole
Other Study ID Numbers
- AAAC0553
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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The Affiliated Hospital of Qingdao UniversityUnknown
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Trans Tasman Radiation Oncology GroupActive, not recruitingBreast CancerAustralia, New Zealand
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Havah Therapeutics Pty LtdCompletedMammographic DensityAustralia
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Massachusetts General HospitalNational Institute on Aging (NIA)Completed
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Havah Therapeutics Pty LtdGTxCompletedMammographic DensityAustralia