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Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

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ClinicalTrials.gov Identifier: NCT00295646
Recruitment Status : Unknown
Verified August 2015 by Austrian Breast & Colorectal Cancer Study Group.
Recruitment status was:  Active, not recruiting
First Posted : February 24, 2006
Last Update Posted : August 4, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: tamoxifen Drug: anastrozole Drug: zoledronic acid Phase 3

Detailed Description:

The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to 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 BMD measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).


Study Design

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
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: AZ (Arimidex+Zoledronat)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronat; zoledronic acid)
Drug: anastrozole
1 mg/d
Other Name: Arimidex
Drug: zoledronic acid
4 mg q6m
Other Name: Zoledronate, Zometa
Active Comparator: TZ (Tamoxifen+Zoledronat)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronat; zoledronic acid)
Drug: tamoxifen
20 mg/d
Other Name: Nolvadex
Drug: zoledronic acid
4 mg q6m
Other Name: Zoledronate, Zometa
Active Comparator: AC (Arimidex Control)
Study Drug Arimidex (Anastrozole)
Drug: anastrozole
1 mg/d
Other Name: Arimidex
Active Comparator: TC (Tamoxifen Control)
Study Drug Nolvadex (Tamoxifen)
Drug: tamoxifen
20 mg/d
Other Name: Nolvadex


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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


  Show 72 Study Locations
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
AstraZeneca
Novartis Pharmaceuticals
Investigators
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00295646     History of Changes
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: August 4, 2015
Last Verified: August 2015

Keywords provided by 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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Zoledronic acid
Diphosphonates
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