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NCT00107263
A Randomized, Controlled, Open-Label Trial of Empiric Prophylactic vs. Delayed Use of Zoledronic Acid for Prevention of Bone Loss in Postmenopausal Women With Breast Cancer Initiating Therapy With Letrozole After Tamoxifen
Phase 3 trial testing letrozole in Breast Cancer in 558 participants. Completed in 1 August 2012.
1 March 2007
Quick facts
| Lead sponsor | Alliance for Clinical Trials in Oncology |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 558 |
| Start date | 1 January 2005 |
| Primary completion | 1 March 2007 |
| Estimated completion | 1 August 2012 |
Drugs / interventions tested
- letrozole — full drug profile →
- zoledronic acid (ZOLEDRONIC ACID) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Osteoporosis — all drugs for Osteoporosis →
Sponsor
Alliance for Clinical Trials in Oncology
Who can join
18 and older, female only, with Breast Cancer or Osteoporosis. 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.
-
Average intra-patient change in total lumbar spine (L1-L4) bone mineral density (BMD) as measured by dual energy x-ray absorptiometry at baseline and 1 year after completion of study treatment
Time frame: at 12 months
Sponsor's own description
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Zoledronate may prevent bone loss in patients who are receiving letrozole. It is not yet known which schedule of zoledronate is more effective in preventing bone loss in patients with breast cancer. PURPOSE: This randomized phase III trial is studying two different schedules of zoledronate to compare how well they work in preventing bone loss in postmenopausal women who are receiving letrozole for stage I, stage II, or stage IIIA breast cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Combined effects of the bisphosphonate, zoledronic acid and the aromatase inhibitor letrozole on breast cancer cells in vitro: evidence of synergistic interaction.
Neville-Webbe HL, Coleman RE, Holen I. · · 2010 · cited 37× · PMID 20160726 · DOI 10.1038/sj.bjc.6605579
Verify or expand the search:
- PubMed search for NCT00107263
- 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 Breast Cancer
Currently open trials in the same condition.
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Other Alliance for Clinical Trials in Oncology trials
Trials by the same sponsor.
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- NCT07283939 — Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays · NA · recruiting
- NCT07059884 — Distance-Based Exercise to Preserve Function and Prevent Disability · NA · recruiting
- NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
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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 NCT00107263 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology
- Last refreshed: 2 December 2016
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/NCT00107263.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing