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Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
Plain-language guide to NCT00186121: phase 2 interventional trial of Goserelin, 35 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00186121
- Phase
- phase 2
- Status
- completed
- Start
- 2000-10
- Completion (planned or actual)
- 2013-05
- Participants
- 35 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Breast Cancer
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Goserelin.
It had 1 arm (groups): Anastrozole + Goserelin (experimental).
The registry classes the interventions as drug.
More on the Plan
Pre-menopausal women with estrogen and/or progesterone receptor positive, metastatic or recurrent breast cancer were enrolled and treated with goserelin (Zoladex) monthly and began anastrozole (Arimidex) daily for 21 days following the first injection of goserelin.
Participants continued on treatment until disease progression or unacceptable toxicity.
Who Took Part
35 actual participants took part.
It was open to women only aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive. Premenopausal, defined as any of:. Last menstrual period within 3 months, or. Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,. If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range.
The full record lists 23 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Goserelin study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2000-10 with completion listed for 2013-05.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Objective Response Rate (ORR) (time frame: 3 months).
It also tracked 6 secondary outcomes, for example Response Rates, Time-to-Progression (TTP), Overall Survival (OS), Estradiol Suppression and Serious Adverse Events.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Goserelin in 35 people.
Its size is small, so on its own it can only give an early look.
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.