Clinical trial · Interventional
Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL)
A Randomised, Multicentre, Pragmatic Trial Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL)
NCT03664687CI-TRIAL-00117032REaCT-ZOLcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
REaCT ZOL will compare one 4 mg dose of Zoledronate vs. one 4 mg dose of Zoledronate given every 6 months for 3 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronate | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Zoledronate one dose (4 mg)
- description
- One 4 mg dose of Zoledronate
- interventionNames
- Drug: Zoledronate
- type
- ACTIVE_COMPARATOR
- label
- Zoledronate 4 mg every 6 months x 3 years
- description
- One 4 mg dose of Zoledronate given every 6 months for 3 years
- interventionNames
- Drug: Zoledronate
Primary outcomes (4)
- measure
- Multiple Site Activation
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Commencing zoledronate within 3 months of starting neoadjuvant or adjuvant endocrine therapy or within 3 months of completion of neoadjuvant or adjuvant chemotherapy for early stage breast cancer * Patients receiving any intravenous or oral biphosphonates, or subcutaneous denosumab for the treatment of osteoporosis must discontinue treatment prior to baseline evaluation * ECOG performance status equal or less than 2 and life expectancy of more than 12 months * Serum creatinine greater than 30 ml/min and corrected serum calcium equal or greater than 2 mmol/l within 4 weeks before first zoledronate infusion * Age equal or greater than 18 years * Able to provide written consent Exclusion Criteria: * Metastatic disease * History of osteonecrosis of the jaw * Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug (e.g. fructose) * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol * Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)\* \*Women/men of child bearing potential must have agreed to use two effective contraceptive methods while on study. A women is considered to be of 'childbearing potential' if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods. 'effective contraception' also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as complete hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate participant chooses to become heterosexually active during the period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures. Examples of effective methods of contraception: Male condom plus spermicide; Cap plus spermicide; Diaphragm plus spermicide; intrauterine device (Copper T, Progesterone T; Levonorgestrel-releasing intrauterine system (i.e. Mirena); hormonal methods (implants, hormonal shot or injection, combined pill, minipill, patch).
References
Publications (4)
- BACKGROUNDAwan A, Ng T, Conter H, Raskin W, Stober C, Simos D, Pond G, Dhesy-Thind S, Mates M, Kumar V, Fergusson D, Hutton B, Saunders D, Vandermeer L, Clemons M; REaCT Investigators. Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer. J Bone Oncol. 2020 Dec 13;26:100343. doi: 10.1016/j.jbo.2020.100343. eCollection 2021 Feb. PMID 33425673
- BACKGROUNDMcGee S, Alzahrani M, Vandermeer L, Cole K, Larocque G, Awan A, Hutton B, Pond G, Saunders D, Clemons M. Adjuvant bisphosphonate use in patients with early stage breast cancer: a physician survey. Breast Cancer Res Treat. 2021 Jun;187(2):477-486. doi: 10.1007/s10549-021-06147-1. Epub 2021 Mar 23. PMID 33755864
- BACKGROUNDMcGee S, AlZahrani M, Stober C, Ng TL, Cole K, Larocque G, Awan A, Sehdev S, Hilton J, Vandermeer L, Hutton B, Pond G, Saunders D, Clemons M. Adjuvant bisphosphonate use in patients with early stage breast cancer: Patient perspectives on treatment acceptability and potential de-escalation. J Bone Oncol. 2021 Feb 19;27:100351. doi: 10.1016/j.jbo.2021.100351. eCollection 2021 Apr. PMID 33680749
- BACKGROUNDClemons M, Stober C, Pond GR, Conter H, Simos D, Dhesy-Thind S, Mates M, Trinkaus M, Hilton J, Savard MF, Fergusson D, Vandermeer L, Awan AA. Every Six-Month versus Single-Dose Adjuvant Zoledronate in Early Breast Cancer. NEJM Evid. 2026 Jun;5(6):EVIDoa2500202. doi: 10.1056/EVIDoa2500202. Epub 2026 May 26. PMID 42187551