CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Anastrozole (Arimidex) +1 moredrug
Likely dose
Anastrozole 1 mg orally daily plus goserelin (Zoladex) injectionsAI-extracted
Key inclusion· 4
  • Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic breast carcinoma that is progressive
  • Premenopausal status, defined by recent menstruation, FSH level, or estradiol in premenopausal range
  • Estrogen and/or progesterone receptor positive by IHC or competitive binding assay on metastatic or primary tumor
  • ECOG performance status 0, 1, or 2
Key exclusion· 8
  • Active, unresolved infection
  • Active malignancy other than breast cancer (except in situ cervical carcinoma or non-melanomatous skin cancers) within past 5 years
  • Prior aromatase inhibitor or inactivator treatment
  • Prior LHRH agonist/antagonist treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00186121
NCT00186121Phase 2Completed

A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

Stanford University·interventional·Posted Sep 16, 2005·Updated Oct 7, 2019

In Brief

A Phase 2 clinical trial evaluating Anastrozole (Arimidex) and Goserelin (Zoladex) for Breast Cancer. Completed, enrolled 35 participants across 1 site.

Detailed Summary

To evaluate the antitumor activity, toxicity, and effectiveness of the combination of goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with hormone receptor positive metastatic carcinoma of the breast.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartOct 1, 2000
Primary CompletionMay 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 12.6 yearsPosted 20.8 years ago

Interventions

Anastrozole (Arimidex)drug

Anastrozole is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone

Goserelin (Zoladex)drug

Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women