Invasive Breast Cancer
Conditions
Keywords
Postmenopausal women, ER+, Estrogen positive, PR+, Progesterone positive
Brief 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.
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.
Interventions
DRUGAnastrozole
1mg PO daily for two weeks prior to scheduled surgery
Sponsors
Avon Foundation
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery | Two weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Presurgical Oral Anastrozole 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.
Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Presurgical Oral Anastrozole |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 66 years |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 participants |