Breast Carcinoma
Conditions
Brief summary
The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases. The subjects are being asked to participate in this research study. They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer but has not been approved for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in this study. The purpose of this study is to find out if Fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving Fulvestrant.
Interventions
DRUGTamoxifen
20mg
DRUGFulvestrant
250mg
Sponsors
AstraZeneca
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women with newly diagnosed DCIS. Women will be considered to be in menopause if they fall into one of the following groups: * Age \> 60 * Age \> 45 with amenorrhea \> 1 year with intact uterus * Status post bilateral oophorectomies * FSH/estradiol levels in postmenopausal range for the institution * DCIS must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (Mammotome) or an equivalent method. * There must be available tissue from the diagnostic biopsy to perform molecular markers. * Baseline mammogram within 8 weeks of study entry. * Serum creatinine less than or equal to 2.0 mg/dl. * Total bilirubin less than or equal to 2.0 upper limit of normal (ULN), transaminases (SGOT and/or SGPT) and alkaline phosphatase may be up to 2.5 x institutional upper limit of normal (ULN), AGC greater than or equal to 1500, platelets greater than or equal to 100,000, Hemoglobin greater than or equal to 8.0 g/dl * Peripheral neuropathy grade 0-1. * No prior therapy for DCIS. * SWOG performance status of less than or equal to 1 * All patients must provide informed written consent
Exclusion criteria
* Prior hormonal therapy (antiestrogens, estrogen, SERM's, progestins, or aromatase inhibitors) within 6 months of study entry. * Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment. * History of DVT or Pulmonary Embolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment | 6 months after treatment of last patient enrolled | Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Changes in Mammographic Density | 6 months after treatment of last patient enrolled | The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the USC+LAC General Hospital between August 2006 to April 2008.
Pre-assignment details
The study had no pre-assignment criteria.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Control Group | 1 |
| Arm 2: Tamoxifen Group | 1 |
| Arm 3: Low Dose Fulvestrant | 1 |
| Arm 4: High Dose Fulvestrant | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | Arm 1: Control Group | Arm 2: Tamoxifen Group | Arm 3: Low Dose Fulvestrant | Arm 4: High Dose Fulvestrant | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 1 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 1 / 1 | 0 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment
Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.
Time frame: 6 months after treatment of last patient enrolled
Population: Analysis was not conducted since there was only 1 subject randomized on to each of the treatment arms.
Secondary
Number of Participants With Changes in Mammographic Density
The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.
Time frame: 6 months after treatment of last patient enrolled
Population: Analysis was not conducted since there was only 1 subject accrued on to each of the treatment arms.