Phase 3
Completed N=3,470
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
| Outcome | Result | p-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
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.