ABCSG 12 Details

Tamoxifen compared to anastrozole, single or in combination with zoledronat in pre-menopausal patients with breast cancer stadium I and II and hormone-receptor-positive tumor

Sample size:
1.250 *)

*) increase to 1.800 patients, amendment 5


Contact ABCSG-Trial office

E-mail: info@abcsg.at
Phone: +43 1 408 92 30
Fax: +43 1 409 09 90

Design


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Primary objectives:

To compare overall survival (OS) and relapse-free survival (RFS) between Tamoxifen and Anastrozole; to compare reduction/inhibition of boneloss because of ± Zoledronate

Secundary objectives:

To compare overall survival (OS) and relapse-free survival (RFS) between Tamoxifen ± Zoledronate and Anastrozole ± Zoledronate; Comparison of development of bone metastases

Inclusion criteria:

  1. Signed consent prior to randomization
  2. Histological proven breast cancer
  3. pT1b-3
  4. yT0 or yT1a
  5. Complete surgically removed primary tumor with histologically clear margins
  6. Not more than 9 positive axillary lymph nodes
  7. At least 10 examined axillary lymph nodes
  8. ER- and/or PgR-positive (at least positive or 10 fmol/mg)
  9. No distant metastasis
  10. Karnofsky Score ≥ 70%
  11. Praemenopausality and minimum age 19 years (praemenopausality is defined by clinically estimated, regular menstrual cycle or the last menstrual bleeding not longer ago than one year prior to study entry; in uncertain cases the FSH and LH serum level within the praemenopausal norm should be defined)
  12. Negative pregnancy test

Exclusion criteria:

  1. No signed consent prior to randomization
  2. T1a breast cancer (except yT1a)
  3. T4d breast cancer or yT4
  4. Any past or present neoplasms (except basal cell carcinoma of the skin or in situ carcinoma of the cervix)
  5. Current pregnancy or lactation
  6. Randomisation later than 8 weeks postoperative
  7. Preoperative radiotherapy
  8. Any previous or concurrent systemic chemotherapy (except preoperative chemotherapy)
  9. Concurrent orale contraception
  10. Any clinial condition that unfits the patient for adjuvant therapy after a breast cancer surgery
  11. Serum creatinine ≥ 3 mg/dl (265 µmol/l)
  12. Serum calcium < 8.0 mg/dl (2.0 µmol/l) or > 12.0 mg/dl (3.0 µmol/l)
  13. Osteomalacia, osteogenesis imperfecta
  14. Treatment with bisphosphonates within 12 months prior to randomisation
  15. Chronic systemic treatment with adrenalcorticosteroids (> 3 months corresponding 10 mg/daily prednisone or more within the last 12 months prior to screening)
  16. Systemic use of corticosteroids, except inhalative corticosteroids (< 1.000 mg/daily)
  17. Anticonvulsive treatment with phenytoin, phenobarbital or other antiepileptical drugs (chronic use within the last 12 months prior to randomisation)
  18. Contraindications to any of the study medications