Phase 3
Completed N=197
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
Source: ClinicalTrials.gov NCT00605267 ↗Enrolled (actual)
197
Serious AEs
0.5%
Results posted
Sep 2012
Primary outcomePrimary: Best Overall Response Rate (BORR) (Calliper) — 70.4; 50.5 Percentage of Participants
Summary
The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response Rate (BORR) (Calliper) |
70.4; 50.5 | — |
| PRIMARY Best Overall Response Rate (BORR) (US) |
58.2; 42.4 | — |
| PRIMARY Best Overall Response Rate (BORR) (MRI/CT) |
64.3; 37.4 | — |
| SECONDARY Bone Mineral Density (BMD) Lumbar Spine |
-5.8; -2.9 | — |
| SECONDARY Bone Mineral Density (BMD) Cervical Thighbone |
-2.5; -0.5 | — |
| SECONDARY Bone Turnover Marker (BAP) EIA Method |
7.1941; 0.7333 | — |
| SECONDARY Bone Turnover Marker (BAP) CLEIA Method |
3.96; -0.75 | — |
| SECONDARY Bone Turnover Marker (NTX) |
9.17; 2.59 | — |
| SECONDARY Serum Oestrone (E1) Concentrations |
0.028; 0.341 | — |
| SECONDARY Serum Oestradiol (E2) Concentrations |
0.041; 0.082 | — |
| SECONDARY Oestrogen Receptor (ER) Status |
2; 1; 92; 89; 0; 0 | — |
| SECONDARY Progesterone Receptor (PgR) Status |
60; 19; 29; 59; 4; 9 | — |
| SECONDARY Human Epidermal Growth Factor Receptor 2 (HER2) Status |
0; 0; 0; 0; 92; 88 | — |
| SECONDARY Histopathological Response Rate (HRR) |
41.8; 27.3 | — |
| SECONDARY Functional Assessment of Cancer Therapy-Breast (FACT-B) |
-4.42; -2.65 | — |
| SECONDARY Endocrine Subscale (ES) |
-8.85; -6.27 | — |
| SECONDARY Anastrozole Plasma Concentrations (Cmin) |
29.7 | — |
Eligibility Criteria
Inclusion Criteria
- Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent
Exclusion Criteria
- Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).
Data sourced from ClinicalTrials.gov (NCT00605267). 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.