Simultaneous Versus Sequential Use of Adjuvant Chemotherapy and GnRHa in Treating ER+,Premenopausal Breast Cancer

What Was Tested

The trial (phase 3) is built around Goserelin.

It had two arms (groups): Zoladex combined with chemotherapy (experimental) and Zoladex after chemotherapy (active comparator).

The registry classes the interventions as drug.

More on the Plan

However this is still a controversial issue.

Who Took Part

216 actual participants took part.

It was open to women only aged up to 45 years.

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

Examples of who could join: Primary invasive breast cancer pathologically approved by core needle or open biopsy. Breast conservation surgery followed by whole breast radiation. Axillary dissection or sentinel node biopsy. Need adjuvant chemotherapy after surgery. Patients taking neo-chemotherapy are eligible.

The full record lists 19 inclusion and 9 exclusion criteria; among the exclusions: patients with metastatic malignant tumor; previous history of asynchronous bilateral breast cancer; any non-malignant systemic disease which interfere long time follow up.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

The Goserelin group and the comparison group ran side by side rather than switching.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-06 with completion listed for 2017-08.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Resumption of menstruation (time frame: 1 year).

It also tracked 3 secondary outcomes, for example RFS, OS and Other adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 216 people.

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

More context: the Goserelin compound page, all human trials.