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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

NCTNCT00295646 (opens ClinicalTrials.gov in a new tab)Other idABCSG-12Other idCZOL 446 1B 01Other idZol-A-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,803 participants (actual)
Sponsor
Austrian Breast & Colorectal Cancer Study Group · Network
Design
Randomized · Open label (no masking)
Countries
2 countries

Austria, Germany

Start
Jun 1999
Primary completion
27 Mar 2008
Completion
26 Jun 2018
First posted
24 Feb 2006 (estimated)
Last update posted
15 Mar 2024
Conditions
Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2000200520102015
  1. Ph 3

    Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

    NCT00295646

    Jun 1999 to 26 Jun 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • tamoxifenDrug
  • anastrozoleDrug
  • zoledronic acidDrug
  • goserelinOther

Arms4

  • Active comparator

    AZ (Arimidex+Zoledronate)

    Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)

  • Active comparator

    TZ (Tamoxifen+Zoledronate)

    Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)

  • Active comparator

    AC (Arimidex Control)

    Study Drug Arimidex (Anastrozole)

  • Active comparator

    TC (Tamoxifen Control)

    Study Drug Nolvadex (Tamoxifen)

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)

    Time frame · Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

    Registry description

    DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause

  2. Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)

    Time frame · Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

    Registry description

    DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause

Secondary outcomes(4)

  1. Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)

    Time frame · Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

    Registry description

    RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer

  2. Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)

    Time frame · Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

    Registry description

    RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer

  3. Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)

    Time frame · Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

    Registry description

    OS is defined as time from randomization to death from any cause

  4. Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)

    Time frame · Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

    Registry description

    OS is defined as time from randomization to death from any cause

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)

GroupValue (years)
AZ (Arimidex+Zoledronate)NA
TZ (Tamoxifen+Zoledronate)NA
AC (Arimidex Control)NA
TC (Tamoxifen Control)NA
Primary outcomeMedian· Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)

GroupValue (years)
AZ (Arimidex+Zoledronate)NA
TZ (Tamoxifen+Zoledronate)NA
AC (Arimidex Control)NA
TC (Tamoxifen Control)NA
Secondary and other outcome results(4)
Secondary outcomeMedian· Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)

GroupValue (years)
AZ (Arimidex+Zoledronate)NA
TZ (Tamoxifen+Zoledronate)NA
AC (Arimidex Control)NA
TC (Tamoxifen Control)NA
Secondary outcomeMedian· Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)

GroupValue (years)
AZ (Arimidex+Zoledronate)NA
TZ (Tamoxifen+Zoledronate)NA
AC (Arimidex Control)NA
TC (Tamoxifen Control)NA
Secondary outcomeMedian· Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)

GroupValue (years)
AZ (Arimidex+Zoledronate)NA
TZ (Tamoxifen+Zoledronate)NA
AC (Arimidex Control)NA
TC (Tamoxifen Control)NA
Secondary outcomeMedian· Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.

Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)

GroupValue (years)
AZ (Arimidex+Zoledronate)NA
TZ (Tamoxifen+Zoledronate)NA
AC (Arimidex Control)NA
TC (Tamoxifen Control)NA

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
AZ (Arimidex+Zoledronate)Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) anastrozole: 1 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days9 / 45067 / 450355 / 450
TZ (Tamoxifen+Zoledronate)Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) tamoxifen: 20 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days7 / 450103 / 450320 / 450
AC (Arimidex Control)Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days18 / 45355 / 453340 / 453
TC (Tamoxifen Control)Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days8 / 45093 / 450290 / 450

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

More studies

6 studies on this page

Indexing hint: Randomized controlled trial · 2015

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.

Gnant et al. 2015Annals of oncology : official journal of the European Society for Medical Oncologycited by 219

PMID 25403582DOI 10.1093/annonc/mdu544PUB-25403582

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2011

Impact of body mass index on the efficacy of endocrine therapy in premenopausal patients with breast cancer: an analysis of the prospective ABCSG-12 trial.

Pfeiler et al. 2011Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 176

PMID 21555684DOI 10.1200/jco.2010.33.2585PUB-21555684

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2011

Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial.

Gnant et al. 2011The Lancet. Oncologycited by 350

PMID 21641868DOI 10.1016/s1470-2045(11)70122-xPUB-21641868

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2009

Corrected

Endocrine therapy plus zoledronic acid in premenopausal breast cancer.

Gnant et al. 2009The New England journal of medicinecited by 741

PMID 19213681DOI 10.1056/nejmoa0806285PUB-19213681

Full text at the publisher
Publisher pageRead the notice

Indexing hint: Randomized controlled trial · 2008

Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 5-year follow-up of the ABCSG-12 bone-mineral density substudy.

Gnant et al. 2008The Lancet. Oncologycited by 275

PMID 18718815DOI 10.1016/s1470-2045(08)70204-3PUB-18718815

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2007

Zoledronic acid prevents cancer treatment-induced bone loss in premenopausal women receiving adjuvant endocrine therapy for hormone-responsive breast cancer: a report from the Austrian Breast and Colorectal Cancer Study Group.

Gnant et al. 2007Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 232

PMID 17159195DOI 10.1200/jco.2005.02.7102PUB-17159195

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedAdams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2. PMID 38979716
  • DerivedBeltran-Bless AA, Clemons MJ, Fesl C, Greil R, Pond GR, Balic M, Vandermeer L, Bjelic-Radisic V, Singer CF, Steger GG, Helfgott R, Egle D, Solkner L, Gampenrieder SP, Kacerovsky-Strobl S, Suppan C, Ritter M, Rinnerthaler G, Pfeiler G, Fohler H, Hlauschek D, Hilton J, Gnant M. Does the number of 6-monthly adjuvant zoledronate infusions received affect treatment efficacy for early breast cancer? A sub-study of ABCSG-12. Eur J Cancer. 2023 Feb;180:108-116. doi: 10.1016/j.ejca.2022.12.003. Epub 2022 Dec 10. PMID 36592505

Eligibility

Who could join, as posted.

Sex
Female
Age
from 19 Years up to 59 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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