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

Starting soon

Conditions studied: Metastatic Breast Cancer, Tumor, Muscle Neoplasms, Chronic Pain

In brief

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.

Key facts

Study ID

NCT06154590

Run by

DR. DIANE CHISESI NFS. MD. PHD.

People needed

100

Starts

2024-07-01

Expected to finish

2026-09-01

Last updated by the study team

2023-12-04

Who can join

Age: 44 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• PNAF Medical — Colorado Springs, Colorado, United States

Full record on ClinicalTrials.gov

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