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Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)


Phase 3
19 Years
59 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

28.05.2008

Safety Issue:

No

Principal Investigator

Raimund Jakesz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Austrian Breast & Colorectal Cancer Study Group

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

ABCSG-12

NCT ID:

NCT00295646

Start Date:

June 1999

Completion Date:

June 2015

Related Keywords:

  • Breast Cancer
  • ABCSG
  • 12
  • Phase 3
  • breast cancer
  • anastrozole
  • tamoxifen
  • zoledronic acid
  • premenopausal
  • hormone receptor-positive
  • Stage I
  • Stage II
  • bone mineral density
  • BMD
  • bisphosphonate
  • zoledronate
  • Breast Neoplasms

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