Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
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| ClinicalTrials.gov Identifier: NCT00295646 |
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Recruitment Status :
Completed
First Posted : February 24, 2006
Last Update Posted : December 19, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: tamoxifen Drug: anastrozole Drug: zoledronic acid | Phase 3 |
The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to Good Clinical Practice (GCP) guidelines. Patients will be randomly assigned to a total of 4 study groups in a 1:1:1:1 assignment ratio. Several stratification criteria will be used in order to ensure balanced distribution of known risk factors.
A total of 1.803 patients will be enrolled in 4 arms. Patients will either be treated with anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm A: Nolvadex alone; arm B: Nolvadex plus zoledronate; arm C: Arimidex alone; arm D: Arimidex plus zoledronate).
Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment period of 3 years. Five Bone Mineral Density (BMD) measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1803 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II) |
| Study Start Date : | June 1999 |
| Actual Primary Completion Date : | September 29, 2015 |
| Actual Study Completion Date : | June 26, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: AZ (Arimidex+Zoledronate)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
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Drug: anastrozole
1 mg/d
Other Name: Arimidex Drug: zoledronic acid 4 mg q6m
Other Name: Zoledronate, Zometa |
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Active Comparator: TZ (Tamoxifen+Zoledronate)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
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Drug: tamoxifen
20 mg/d
Other Name: Nolvadex Drug: zoledronic acid 4 mg q6m
Other Name: Zoledronate, Zometa |
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Active Comparator: AC (Arimidex Control)
Study Drug Arimidex (Anastrozole)
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Drug: anastrozole
1 mg/d
Other Name: Arimidex |
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Active Comparator: TC (Tamoxifen Control)
Study Drug Nolvadex (Tamoxifen)
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Drug: tamoxifen
20 mg/d
Other Name: Nolvadex |
- Comparison of tamoxifen with anastrozole in premenopausal patients with non-metastatic breast cancer and comparison of a subgroup additionally treated with zoledronate to a control subgroup without receiving zoledronate according to DFS. [ Time Frame: 28.05.2008 ]
- For the assessment of the recurrence free survival (RFS) patients receiving tamoxifen will be compared to patients receiving anastrozole and patients receiving zoledronate will be compared to controls, respectively. [ Time Frame: 28.05.2008 ]
- For the assessment of the overall survival (OS) patients receiving tamoxifen will be compared to patients receiving anastrozole and patients receiving zoledronate will be compared to controls, respectively. [ Time Frame: 28.05.2008 ]
- The objective is 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 anti-estrogen or aromatase inhibitor (AI). [ Time Frame: 28.05.2008 ]
- Adverse and severe adverse events will be listed for all therapy subgroups "anastrozole / zoledronate" (AZ), "anastrozole / zoledronate control" (AC), "tamoxifen / zoledronate" (TZ), "tamoxifen / zoledronate control" (TC). [ Time Frame: 28.05.2008 ]
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| Ages Eligible for Study: | 19 Years to 59 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295646
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| Principal Investigator: | Raimund Jakesz, MD | Austrian Breast & Colorectal Cancer Study Group |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Austrian Breast & Colorectal Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT00295646 |
| Other Study ID Numbers: |
ABCSG-12 CZOL 446 1B 01 ( Other Identifier: Novartis ) Zol-A-01 ( Other Identifier: Novartis ) |
| First Posted: | February 24, 2006 Key Record Dates |
| Last Update Posted: | December 19, 2018 |
| Last Verified: | December 2018 |
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Austrian Breast & Colorectal Cancer Study Group (ABCSG) 12 Phase 3 breast cancer anastrozole tamoxifen zoledronic acid premenopausal |
hormone receptor-positive Stage I Stage II bone mineral density BMD bisphosphonate zoledronate |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Zoledronic Acid Anastrozole Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |