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

Study acronym: NASBP-B-09
StatusUnknown
PhaseNot specified
Started

Record status This record was last updated December 4, 2023 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Nov 2023); last known: Not Yet Recruiting
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06154590
Lead Sponsor DR. DIANE CHISESI NFS. MD. PHD.
Collaborators: IRB
Conditions
(from sponsor)		 Metastatic Breast Cancer, Tumor, Muscle Neoplasms, Chronic Pain
Related terms Breast Neoplasms, Chronic Pain, Muscle Neoplasms, Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov