Chronic Pain, Metastatic Breast Cancer, Muscle Neoplasms, Tumor
Conditions
Keywords
Dose Unit, Participants, Confidence Intervals, Cmax
Brief summary
At a median follow-up of 33 months, the combination of anastrozole and NOLVADEX (tamoxifen citrate) did not demonstrate any efficacy benefit when compared to NOLVADEX (tamoxifen citrate) therapy given alone in all patients as well as in the hormone receptor positive subpopulation. This treatment arm was discontinued from the trial. This study is now a combination therapy whereas the median duration of adjuvant treatment for safety evaluation is 59.8 months and 59.6 months for patients receiving anastrozole 1 mg and NOLVADEX (tamoxifen citrate) 20 mg, respectively.
Detailed description
Of importance: (Special group- node positive disease and node negative disease). Among 29,441 patients with ER positive or unknown breast cancer, 58% were entered into trials comparing NOLVADEX (tamoxifen citrate) to no adjuvant therapy and 42% were entered into trials comparing NOLVADEX (tamoxifen citrate) in combination with chemotherapy vs. the same chemotherapy alone. Among these patients, 54% had node positive disease and 46% had node negative disease. The Early Breast Cancer Trialists' Collaborative Group (EBCTCG) conducted worldwide overviews of systemic adjuvant therapy for early breast cancer in 1985, 1990, and again in 1995. In 1998, 10-year outcome data were reported for 36,689 women in 55 randomized trials of adjuvant NOLVADEX (tamoxifen citrate) using doses of 20-40 mg/day for 1-5+ years. Twenty-five percent of patients received 1 year or less of trial treatment, 52% received 2 years, and 23% received about 5 years. Forty-eight percent of tumors were estrogen receptor (ER) positive ( \> 10 fmol/mg), 21% were ER poor ( \< 10 fmol/l), and 31% were ER unknown. This following study is for an alternate treatment plan. Dose specific.
Interventions
DRUGMethod(s)1 Attribution
Intervention(s): Attribution defines the relationship between the adverse event and the investigational agent(s)/intervention. Assign the appropriate category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite. Definitions: Use the Adverse Event Dose Units- Indicate the dosing units (e.g., mg) administered to the patient. TAC, Reporting Group: Participants with Disease, Description: Presence of Disease as Defined by positive reference test. Dosage Form: 1mg Anastrozole, given once daily. 20 mg NOLVADEX (tamoxifen citrate) tablet given once daily, (the 20 mg NOLVADEX (tamoxifen citrate) tablet is bioequivalent to the 10 mg NOLVADEX. (tamoxifen citrate) tablets.)
DRUGMethod(s)2 Attribution,
Intervention(s): -Attribution defines the relationship between the adverse event and the investigational agent(s)/intervention. Assign the appropriate category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite. Definitions: Use Adverse Events. Dose Units- Indicate the dosing units (e.g., mg) administered to the patient TAC. Reporting Group: Participant without Disease, Description: Absence of Disease as defined by negative reference test. Dosage Form: 1mg Anastrozole, given once daily. 20 mg NOLVADEX (tamoxifen citrate) tablet given once daily, (the 20 mg NOLVADEX (tamoxifen citrate) tablet is bioequivalent to the 10 mg NOLVADEX. (tamoxifen citrate) tablets.)
Sponsors
IRB
DR. DIANE CHISESI NFS. MD. PHD.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
44 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* The Median Duration of Adjuvant Treatment for 59.8 Months and 59.6 Months for Patients Receiving Anastrozole 1 mg and NOLVADEX (Tamoxifen Citrate) 20 mg. * Construct Patient Historical Background * Palliative * Pediatric- Under 2 Years of Age, 2-18 Years of Age (does unit adjustments )FYI * Interventional Procedures * BMD Bone Mineral Density (Data if Obtainable) * Notate Receptor Levels (Only Women With Both Estrogen and Progesterone * Levels 10 mo Fmol or Greater) * Notate Radiation Therapy 6 Months (Male, Prostate Cancer, or SAST, Salvage Androgen Suppression) * Notate Did Not Utilize Androgen Suppression as Adjunct Therapy to Radiation Therapy, Yes or no. * Androgen Independent Prostate Cancer * In addition: (for chronic, non-cancer pain), prescribers should determine whether the patient improves functionally on opioids, which could include an opioid trial, and whether the pain relief improves his/her ability to comply with the overall pain management program. * Chronic Pain (Benign) Inpatient/Outpatient * Cancer Pain * Acute Pain, Inpatient/Outpatient * Add here: if prudent-2.2.3.8.1.1. Dose Modification (Change) * Has this patient received either a dose escalation or a de-escalation of this investigational agent during this course of therapy? Use the following codes: * 1 = Yes, planned (i.e., the dose was changed according to protocol guidelines) * 2 = Yes, unplanned (i.e., the dose change was not a part of protocol guide-lines) * 3 = No * 9 = Unknown * Note: If the patient has received a previous escalation or de-escalation of this investigational agent and there has been no further change to the dose during this course, answer no. * Construct a Least Squares Linear Regression Standard Curve, Construct a Least Squares Linear Regression, Peak Height , * Using data from the control (0 ppb) and fortified tissue samples, construct a least squares linear regression standard curve by plotting fortified tissue concentration against peak height (average from duplicate dose can include injection if drug is developed into injector, currently use of tablets) for the resulting equation, y = mx -t- b. * x = concentration (ppb) of results from chemicals or tissue from prior surgeries (if any or in progress for sample tissue) * y = tamoxifen citrate was added to melphalan \[L-phenylalanine mustard (P) and fluorouracil (f) peak height (average value from duplicate does). This will assist in further studies for set up for adjutant cytotoxic chemotherapy if applicable. * m = slope * b = y-intercept * Healthy volunteers/yes * Will accept women 59-70 for use of combination drug-(both estrogen and progesterone receptor levels).
Exclusion criteria
* At a median follow-up of 33 months, the combination of anastrozole and NOLVADEX (tamoxifen citrate) did not demonstrate any efficacy benefit when compared to NOLVADEX (tamoxifen citrate) therapy given alone in all patients as well as in the hormone receptor positive sub-population. This treatment arm was discontinued from the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The combination of anastrozole and NOLVADEX (tamoxifen citrate)was added to adjunct cytotoxic chemothrapy | At a median follow-up of 33 months | Among women with ER positive or unknown breast cancer and positive nodes who received about 5 years of treatment, overall survival at 10 years was 61.4% for NOLVADEX (tamoxifen citrate) vs. 50.5% for control (logrank 2p \< 0.00001). The recurrence-free rate at 10 years was 59.7% for NOLVADEX (tamoxifen citrate) vs. 44.5% for control (logrank 2p \< 0.00001). Among women with ER positive or unknown breast cancer and negative nodes who received about 5 years of treatment, overall survival at 10 years was 78.9% for NOLVADEX (tamoxifen citrate) vs. 73.3% for control (logrank 2p \< 0.00001). The recurrence-free rate at 10 years was 79.2% for NOLVADEX (tamoxifen citrate) versus 64.3% for control (logrank 2p \< 0.00001) |
| female, effective clinical care | 33 months | Breast Cancer Resection Pathology Reporting: pT Category (Primary Tumor) and pN Category (Regional Lymph Nodes) with Histologic Grade: Percentage of breast cancer resection pathology reports that include the pT category (primary tumor), the pN category (regional lymph nodes), and the histologic grade |
Other
| Measure | Time frame | Description |
|---|---|---|
| male. effective clinical care | 6 months | Prostate Cancer: Adjuvant Hormonal Therapy for High Risk Prostate Cancer Patients: Percentage of patients, regardless of age, with a diagnosis of prostate Cancer at high risk of recurrence receiving external beam radiotherapy to the prostate who were prescribed adjuvant hormonal therapy (GnRH agonist or antagonist |
Countries
United States
Contacts
Primary ContactUSCMDR Diane Chisesi, MD PhD LPC.
Backup ContactDr. Diane Chisesi, NFS MD PhD
Outcome results
None listed