At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 63 enrolled
Drug / intervention
letrozole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Prospective Pilot Study Evaluating Efficacy of Intravenous Zoledronic Acid Prophylaxis for Prevention of Aromatase Inhibitor Associated Musculoskeletal Symptoms: ZAP-AIMSS Trial
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Sep 3, 2010·Updated Sep 12, 2018
In Brief
A Phase 2 clinical trial evaluating letrozole and zoledronic acid for Ductal Carcinoma in Situ and 7 related conditions. Completed, enrolled 63 participants across 1 site.
Detailed Summary
RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal symptoms in women receiving hormone therapy for breast cancer. PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast cancer receiving letrozole.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuctal Carcinoma in Situ, Estrogen Receptor-positive Breast Cancer, Progesterone Receptor-positive Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartFeb 2011
Primary CompletionJan 2014
TodayJul 2026
First PostedSep 3, 2010
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.8 years ago
Interventions
letrozoledrug
Given orally
zoledronic aciddrug
Given IV