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NCT01194440
A Phase II Prospective Pilot Study Evaluating Efficacy of Intravenous Zoledronic Acid Prophylaxis for Prevention of Aromatase Inhibitor Associated Musculoskeletal Symptoms: ZAP-AIMSS Trial
Phase 2 trial testing letrozole in Ductal Carcinoma in Situ in 63 participants. Completed in 1 January 2014.
1 January 2014
Quick facts
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 63 |
| Start date | 1 February 2011 |
| Primary completion | 1 January 2014 |
| Estimated completion | 1 January 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- letrozole — full drug profile →
- zoledronic acid (ZOLEDRONIC ACID) — full drug profile →
Conditions studied
- Ductal Carcinoma in Situ — all drugs for Ductal Carcinoma in Situ →
- Estrogen Receptor-positive Breast Cancer — all drugs for Estrogen Receptor-positive Breast Cancer →
- Progesterone Receptor-positive Breast Cancer — all drugs for Progesterone Receptor-positive Breast Cancer →
- Stage I Breast Cancer — all drugs for Stage I Breast Cancer →
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →
Who can join
18 and older, female only, with Ductal Carcinoma in Situ or Estrogen Receptor-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Time frame: 12 months
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01194440
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of letrozole
Trials testing the same drug.
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- NCT06465368 — A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post · Phase 2 · completed
- NCT04942899 — Letrozole Plus Metronomic Capecitabine as First-line Treatment for Patients With Recurrent or Metastatic Breast Cancer · Phase 2 · unknown
- NCT05809024 — Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy · Phase 4 · unknown
- NCT06570031 — ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer · Phase 1 · active not recruiting
Other recruiting trials for Ductal Carcinoma in Situ
Currently open trials in the same condition.
- NCT07095114 — A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients. · NA · recruiting
- NCT06218303 — Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ · Phase 1 · recruiting
- NCT06677944 — Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer · Phase 2 · recruiting
- NCT05218044 — Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ · NA · recruiting
- NCT04666961 — Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ · Phase 2 · recruiting
Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials
Trials by the same sponsor.
- NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting
- NCT06210854 — Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ · Phase 2 · not yet recruiting
- NCT07360119 — Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors · NA · not yet recruiting
- NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
- NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01194440 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Last refreshed: 14 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01194440.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing