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Phase 3 Completed N=3,470 Randomized Treatment

Secondary Adjuvant Long Term Study With Arimidex

Source: ClinicalTrials.gov NCT00295620 ↗
Enrolled (actual)
3,470
Serious AEs
33.4%
Results posted
Oct 2019
Primary outcomePrimary: Disease-free Survival After Prolonged Endocrine Treatment — NA; NA Years — p=0.425

Summary

The study assesses the effect of further 2 years vs further 5 years of adjuvant treatment with anastrozole after initial 5 years of adjuvant endocrine therapy.

Outcome Measures

OutcomeResultp-value
PRIMARY
Disease-free Survival After Prolonged Endocrine Treatment
NA; NA 0.425
SECONDARY
Overall Survival After Prolonged Endocrine Treatment
NA; NA 0.867
SECONDARY
Time to First Clinical Fracture
NA; NA 0.052
SECONDARY
Time to Secondary Carcinoma
NA; NA 0.678
SECONDARY
Time to Contralateral Breast Cancer
NA; NA 0.531

Eligibility Criteria

Inclusion criteria

  • Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie and/or radiotherapie.
  • No distant metastasis at randomization
  • No relapse at randomization
  • TNM- classification at time of diagnosis: T1-3, N0 and N+, M0
  • Estrogen- and or progesterone positive before the beginningof primary endocrine therapy
  • Endocrine therapy for 5 years (maximum deviation ±12 months)
  • Therapy break (from the preliminary therapie) maximum 12 months.
  • Informed Consent before the randomisation

Exclusion criteria

  • Premenopausal patients or patients with non definable menopausal statusat time of randomisation
  • Apparent secondary malignant tumor or status after secondary malignant tumor (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or progesteronereceptor positive on both sides at the time of diagnosis; in situ carcinomaof the cervix and basal cell carcinoma of the skin)
  • General contraindication respectively hypersensitivity to Anastrozol.
  • In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.
  • Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy
  • Known liver- and/or kidneyinsufficiency
  • Performance Index >2 according to WHO
  • Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more than 6 months since primary surgery of the mamma carcinoma
  • Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.
  • Lacking compliance of the patient
  • Legal incompetence and/or other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial
  • Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the time of admission into the study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00295620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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