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Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
Plain-language guide to NCT00605267: phase 3 randomized trial of Goserelin, 197 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00605267
- Phase
- phase 3
- Status
- completed
- Start
- 2007-10
- Completion (planned or actual)
- 2009-11
- Participants
- 197 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Breast Cancer
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Goserelin.
It had two arms (groups): 1 (active comparator) and 2 (experimental).
Tamoxifen.
Anastrazole (Arimidex).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 197 actual participants took part.
It was open to women only aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent.
The full record lists 1 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and triple-blind.
Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Goserelin.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2007-10 with completion listed for 2009-11.
It ran at 4 sites in Japan (4).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Best Overall Response Rate (BORR) (Calliper) (time frame: 24 weeks). Best Overall Response Rate (BORR) (US) (time frame: 24 weeks). Best Overall Response Rate (BORR) (MRI/CT) (time frame: 24 weeks).
It also tracked 14 secondary outcomes, for example Bone Mineral Density (BMD) Lumbar Spine, Bone Mineral Density (BMD) Cervical Thighbone, Bone Turnover Marker (BAP) EIA Method, Bone Turnover Marker (BAP) CLEIA Method, Bone Turnover Marker (NTX) and Serum Oestrone (E1) Concentrations.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Goserelin in 197 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Goserelin compound page, all human trials.
Our Notes on the Compound
Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.