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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

NCT06154590 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-12-04

No results posted yet for this study

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.

Conditions

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.)

Sponsors & Collaborators

  • IRB

    collaborator UNKNOWN

  • DR. DIANE CHISESI NFS. MD. PHD.

    lead OTHER

Principal Investigators

  • USCMDR Diane Chisesi, MD PhD CI · Chisesi, Diane M,: Army/Air Force/Mil/DHS/Other

Eligibility

Min Age
44 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-08-31
Completion
2026-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06154590 on ClinicalTrials.gov