An interventional study of Anastrozole in Invasive Breast Cancer, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-01-11.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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.
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 10 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
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Exclusion Criteria:
1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.
Drug: Anastrozole
1mg PO daily for two weeks prior to scheduled surgery
Also known as: Arimidex
Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery
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.
Time frame: Two weeks
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.
| Milestone | Presurgical Oral Anastrozole |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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.
| participants | Presurgical Oral Anastrozole |
|---|---|
| Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery | 10 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Presurgical Oral Anastrozole | — | 0/10 (0%) | 10/10 (100%) |
| Event | Presurgical Oral Anastrozole |
|---|---|
| DiarrheaGastrointestinal disorders | 4/10 |
| FatigueGeneral disorders | 4/10 |
| Hot flashesVascular disorders | 4/10 |
| Age, Categorical(Participants) | Presurgical Oral Anastrozole |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 5 |
| Age, Continuous(years) | Presurgical Oral Anastrozole |
|---|---|
| Median | 66 (49 to 84) |
| Sex: Female, Male(Participants) | Presurgical Oral Anastrozole |
|---|---|
| Female | 10 |
| Male | 0 |
| Region of Enrollment(participants) | Presurgical Oral Anastrozole |
|---|---|
| United States | 10 |
Plan to share: Undecided
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Columbia University