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NCT06154590

Anastrozole Adjuvant Trial - Study of Anastrozole Compared to NOLVADEX (Tamoxifen Citrate) for Adjuvant Treatment of Early Breast Cancer Clinical Studies), Adjunct Cytotoxic Chemotherapy and Malignant Joint Tumor

Sponsor: DR. DIANE CHISESI NFS. MD. PHD.

View on ClinicalTrials.gov

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.

Official title: Anastrozole Adjuvant Trial - Study of Anastrozole Compared to NOLVADEX (Tamoxifen Citrate) for Adjuvant Treatment of Early Breast Cancer (Clinical Studies), Tamoxifen Citrate Was Added to Adjunct Cytotoxic Chemotherapy- Treatment of Malignant Joint Tumor.

Key Details

Gender

All

Age Range

44 Years - 59 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-07

Completion Date

2026-09

Last Updated

2023-12-04

Healthy Volunteers

Yes

Conditions

Metastatic Breast Cancer Tumor Muscle Neoplasms Chronic Pain

Interventions

DRUG

Method(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.)

DRUG

Method(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.)

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.

Locations (1)

PNAF Medical

Colorado Springs, Colorado, United States