Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to see if tumors respond to endocrine therapy by taking a total of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.
Patients who are eligible (newly diagnosed hormone positive clinical stage 1 or 2 breast cancer) will be approached about the study. If they sign informed consent a prescription for 21 doses of Tamoxifen will be provided. The patient's surgery will be scheduled at a time convenient for the patient and the surgeon. Once the surgery has been scheduled, a medication calendar will be completed that allows the patient to take tamoxifen for 7 days preoperatively with the 7th dose of tamoxifen to coincide with the day before surgery. The patient will continue to take tamoxifen for 2 weeks (14 days) after surgery. Patients will then proceed along normal treatment guidelines. For those needing chemotherapy or radiation therapy, we recommend the long term endocrine therapy start at the conclusion of chemo and/or radiation treatments. For those not going on to any additional therapy, the prescription for endocrine therapy will be written at the initial post-operative visit.
Unstained slides from the formalin-fixed, paraffin-embedded tissue blocks from the patient's breast tissue from which the original diagnosis of breast cancer was made by H&E will be stained for Ki67. After endocrine therapy and subsequent resection, carcinoma will be confirmed by the participating pathologist on H&E, and Ki67 will be performed on unstained slides from a representative tissue block containing invasive carcinoma. The pathologist will circle a designated area of tumor on the H&E slide and both the H&E and immunostained (Ki67) slides will be scanned in a digital imaging device (Aperio XT Scanscope), which quantitatively analyzes the tumor designated by the pathologist with image analysis algorithms. The algorithm accurately detects regions of interest and distinguishes cells and sub-cellular objects within these target regions. It determines morphology and expression profiles per individual cell or cell compartment. For Ki67 analysis, a nuclear Immunohistochemistry (IHC) algorithm will be used.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | All patients enrolled in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ki67 Expression in Tumors | Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FACT-ES Symptom Scores | Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 18 months following breast surgery to assess quality of life. The difference in total score from baseline to 18 months was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FACT-ES Symptom Scores | Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 7 days following start of tamoxifen to assess quality of life while on tamoxifen. The difference in total score from baseline to 7 days was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life. |
Inclusion Criteria:
Exclusion Criteria:
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Fluoxetine - should be discontinued 30 days prior to starting tamoxifen Paroxetine - should be discontinued 5 days prior to starting tamoxifen Sertraline - should be discontinued 5 days prior to starting tamoxifen Bupropion - should be discontinued 5 days prior to starting tamoxifen
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leigh Neumayer, MD | Huntsman Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tamoxifen Pre and Post Breast Surgery | All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tamoxifen Pre and Post Breast Surgery | All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Ki67 Expression in Tumors | Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen. | 3 were not evaluable due to rescheduling of surgery; 1 not evaluable due to pharmacy error. 2 patients had no invasive tumor on Ki-67 slides from pretreatment biopsy, and 2 patients had no invasive tumor on post-treatment surgery and were not evaluable. | Posted | Mean | 95% Confidence Interval | percentage change in Ki67 | 7 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tamoxifen Pre and Post Breast Surgery | All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic Event | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurred Vision | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josiah Hawks | Huntsman Cancer Institute | 8015850601 | Josiah.Hawks@hci.utah.edu |
Not provided
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Breast cancer surgery | Procedure | Breast cancer surgery |
|
| 18 months |
| Number of Participants With Long Term Endocrine Therapy Adherence | For the patient population on this study, endocrine therapy was indicated for 5 years post-surgery according to the current standard of care recommendations for hormone positive breast cancer. Endocrine therapy was prescribed as standard of care as appropriate for each patient's situation. At 18 months post-surgery, patients were evaluated to determine if they were taking their endocrine therapy as prescribed. | 18 months |
| Correlation Between Changes in Ki67 and Symptoms | Evaluate correlation between changes in Ki67 expression and symptom scores. Differences between changes in FACT-ES total score were correlated with changes in Ki67 expression using a the Spearman correlation method and results are expressed as the correlation coefficient. | 7 days |
| 7 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in FACT-ES Symptom Scores | Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 18 months following breast surgery to assess quality of life. The difference in total score from baseline to 18 months was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life. | Of the 44 patients evaluable for the primary outcome measure, 35 completed both baseline and 18 month FACT-ES assessments | Posted | Mean | 95% Confidence Interval | change in units on a scale | 18 months |
|
|
|
| Secondary | Number of Participants With Long Term Endocrine Therapy Adherence | For the patient population on this study, endocrine therapy was indicated for 5 years post-surgery according to the current standard of care recommendations for hormone positive breast cancer. Endocrine therapy was prescribed as standard of care as appropriate for each patient's situation. At 18 months post-surgery, patients were evaluated to determine if they were taking their endocrine therapy as prescribed. | Of the 52 patients enrolled on the study, 38 patients had data regarding long term endocrine therapy at 18 months post-surgery. | Posted | Number | participants adhering to therapy | 18 months |
|
|
|
| Secondary | Correlation Between Changes in Ki67 and Symptoms | Evaluate correlation between changes in Ki67 expression and symptom scores. Differences between changes in FACT-ES total score were correlated with changes in Ki67 expression using a the Spearman correlation method and results are expressed as the correlation coefficient. | Of the 50 patients enrolled Ki67 measurements were obtained for 44. Of the 44 patients which had a Ki67 result, 43 had both a pre and post symptom score. | Posted | Number | spearman correlation coefficient | 7 days |
|
|
|
| Other Pre-specified | Change in FACT-ES Symptom Scores | Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 7 days following start of tamoxifen to assess quality of life while on tamoxifen. The difference in total score from baseline to 7 days was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life. | Of the 50 patients enrolled, 46 had both pre and post FACT-ES total scores. | Posted | Median | Full Range | change in units on a scale | 7 days |
|
|
|
| 1 |
| 52 |
| 42 |
| 52 |
| Dialated Left Pupil | Eye disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| lip swelling | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| oral pain | Gastrointestinal disorders | Systematic Assessment |
|
| toothache | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| irritability | General disorders | Systematic Assessment |
|
| vaginal infection | Infections and infestations | Systematic Assessment |
|
| bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| akathisia | Nervous system disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| dysgeusia | Nervous system disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| anxiety | Psychiatric disorders | Systematic Assessment |
|
| insomnia | Psychiatric disorders | Systematic Assessment |
|
| breast pain | Reproductive system and breast disorders | Systematic Assessment |
|
| period spotting | Reproductive system and breast disorders | Systematic Assessment |
|
| vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| nasal swelling | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| rash maculopapular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| flushing | Vascular disorders | Systematic Assessment |
|
| hot flashes | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |