Phase 3
Completed N=1,803
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
Source: ClinicalTrials.gov NCT00295646 ↗Enrolled (actual)
1,803
Serious AEs
17.6%
Results posted
Mar 2024
Primary outcomePrimary: Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) — NA; NA; NA; NA years — p=0.59
◆ Published Evidence
Highly cited
1,022citations · ~60 / year
Endocrine therapy plus zoledronic acid in premenopausal breast cancer.
Summary
The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.
Linked Publications (5)
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Endocrine therapy plus zoledronic acid in premenopausal breast cancer.
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Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial.
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Zoledronic acid combined with adjuvant endocrine therapy of tamoxifen versus anastrozol plus ovarian function suppression in premenopausal early breast cancer: final analysis of the Austrian Breast and Colorectal Cancer Study Group Trial 12.
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Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis.
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Does the number of 6-monthly adjuvant zoledronate infusions received affect treatment efficacy for early breast cancer? A sub-study of ABCSG-12.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) |
NA; NA; NA; NA | 0.59 |
| PRIMARY Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) |
NA; NA; NA; NA | 0.01 sig |
| SECONDARY Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) |
NA; NA; NA; NA | 0.53 |
| SECONDARY Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) |
NA; NA; NA; NA | 0.01 sig |
| SECONDARY Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS) |
NA; NA; NA; NA | 0.07 |
| SECONDARY Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS) |
NA; NA; NA; NA | 0.10 |
Eligibility Criteria
Inclusion Criteria
- Premenopausal, hormone receptor-positive patient
- Histologically verified (minimally) invasive breast cancer, local radical treatment
- 0-9 involved axillary lymph nodes (≥ 10 histologically examined nodes)
- Tumor stage: pT1b-3, yT0 or yT1a
Exclusion Criteria
- T1a, T4d, yT4; M1
- Previous breast tumor irradiation
- Previous or concurrent chemotherapy (except for preoperative chemotherapy)
- Serum creatinine > 1.5 x UNL or creatinine clearance < 60 ml/min
Data sourced from ClinicalTrials.gov (NCT00295646) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.