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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
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.)
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.)
PNAF Medical
Colorado Springs, Colorado, United States
The combination of anastrozole and NOLVADEX (tamoxifen citrate)was added to adjunct cytotoxic chemothrapy
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)
Time frame: At a median follow-up of 33 months
female, effective clinical care
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
Time frame: 33 months
female, effective clinical care
Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer: Percentage of female patients aged 18 years and older with Stage IC through IIIC, ER or PR positive breast cancer who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12-month reporting period \*Although there a newer version of this measure is available (CMS140v2), a substantive error was discovered in the June 2013 version of this electronically specified clinical quality measure. The PQRS will require the use of the prior, December 2012 version of this measure, which is CMS140v1.
Time frame: 12-month
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