Zoladex Plus Tamoxifen in Breast Cancer

What Was Tested

In this not phased trial, researchers set out to test Goserelin for endometriosis.

It had two arms (groups): Combination (experimental) and Conctrol (active comparator).

The registry classes the interventions as drug.

More on the Plan

After the completion of primary treatment(surgery and/or adjuvant chemotherapy, radiotherapy could be given concurrently with study medication), eligible patients will be randomized to receive Zoladex plus tamoxifen or tamoxifen alone.

The duration of study medication along with the follow-up will be 18 months, or until disease recurrence,or discontinuation of study therapy (as a result of an adverse event, a patient's request, or an investigator's decision), further treatment will be at investigator's discretion.

During the study period, contralateral mammograms and transvaginal ultrasound will be undertaken at baseline and after 6, 12 and 18 months of study medications.

Mammographic density assessment will be undertaken by a single radiologist.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provision of informed consent. Completion of surgery and chemotherapy(if given). Women defined as pre- or perimenopausal according to all of the following: aged 50 years or younger, at least one menstrual period during the last months.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: clinical evidence of metastatic disease; pregnancy or breast-feeding; bilateral oophorectomy;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Nothing was hidden in this open-label Goserelin study: the endometriosis participants and staff both knew the treatment.

It started in 2008-06 with completion listed for 2011-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mammographic percentage density at 18months (time frame: 18months after enrolled).

It also tracked 1 secondary outcome, for example estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Goserelin in 100 people with endometriosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, Endometriosis research.