Female Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. The tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.
Interventions
DRUGEstradiol
10mg oral three times daily
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically or cytologically confirmed breast cancer which is metastatic. * A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from either a prior biopsy of the primary tumor or a metastatic site. . * Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and Her2 negative * Patients must have measurable disease. * Eastern Cooperative Oncology Group performance status 0-1. * Patients with bone metastasis at baseline must agree to treatment with intravenous bisphosphonates * Subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy regimens administered for treatment of their metastatic breast cancer. * Age \>18 years * Life expectancy of greater than 3 months. * Patients must have adequate organ and marrow function as defined below:
Exclusion criteria
* systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2 weeks prior to entering the study * Patients receiving any other investigational agents for breast cancer treatment. * Patients with known brain metastases are excluded 3.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to estradiol. * Patients with any condition of the gastrointestinal tract that is expected to result in an inability to take oral medication * Dysfunctional or post-menopausal vaginal bleeding. * Uncontrolled hypercalcemia/hypocalcemia * Prior history of or active thrombophlebitis, cerebral vascular accident, myocardial infarction, deep venous thrombosis or pulmonary embolism. * History of or active hepatic adenoma. * Uncontrolled intercurrent illness * Pregnant women are excluded from this study * Patients with bone metastasis are excluded if they are unable to receive intravenous bisphosphonate therapy due to the risk for developing hypercalcemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine Tumor Objective Response (OR) Rates | Up to 4 years | OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Benefit (CB) | Up to 4 years | Defined as complete response, partial response, or stable disease at \> 16 weeks |
| Progression-free Survival (PFS) | Up to 4 years | — |
| Median Overall Survival (OS) | Up to 4 years | — |
Countries
United States
Participant flow
Recruitment details
This multicenter phase 2 study was conducted through the Wisconsin Oncology Network. Subjects were recruited from February 2010 through March 2013.
Participants by arm
| Arm | Count |
|---|---|
| Estrogen Therapy Estrogen therapy
Estradiol: 10mg oral three times daily | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Estrogen Therapy |
|---|---|
| Age, Continuous | 57.9 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 0 Participants |
| Stage at Diagnosis Stage I | 3 Participants |
| Stage at Diagnosis Stage II | 9 Participants |
| Stage at Diagnosis Stage III | 4 Participants |
| Stage at Diagnosis Stage IV | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 17 |
| serious Total, serious adverse events | 4 / 17 |
Outcome results
Primary
Determine Tumor Objective Response (OR) Rates
OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Estrogen Therapy | Determine Tumor Objective Response (OR) Rates | 5.9 percentage of participants |
Secondary
Clinical Benefit (CB)
Defined as complete response, partial response, or stable disease at \> 16 weeks
Time frame: Up to 4 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estrogen Therapy | Clinical Benefit (CB) | Complete Response | 0 Participants |
| Estrogen Therapy | Clinical Benefit (CB) | Partial Response | 1 Participants |
| Estrogen Therapy | Clinical Benefit (CB) | Stable Disease at > 16 weeks | 1 Participants |
| Estrogen Therapy | Clinical Benefit (CB) | Stable Disease < 16 weeks | 2 Participants |
Secondary
Median Overall Survival (OS)
Time frame: Up to 4 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estrogen Therapy | Median Overall Survival (OS) | 7.6 months |
Secondary
Progression-free Survival (PFS)
Time frame: Up to 4 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estrogen Therapy | Progression-free Survival (PFS) | 1.9 months |