Adjuvant AI Combined With Zoladex

What Was Tested

This registered phase 3 trial tested Goserelin.

Gallen's guideline, hormone receptor positive was defined as endocrine responsive and endocrine response uncertain categories (table 3-1), and only those with ER or PR expression undetectable were considered as HR negative.

The pathological evaluation of axillary lymph node could be done by sentinel node biopsy (SNB) when axillary nodes were clinically impalpable accompanied with axillary lymph node dissection (ALND) or directly through ALND when axillary nodes appeared to be positive in clinical examination.

It had two arms (groups): Switch to Zoladex + AI for 3-2 years (experimental) and TAM (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 670 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: All patients must have signed and dated an informed consent form. Patients must be female. Primary invasive breast cancer pathologically approved by core needle or open biopsy. A standard radical mastectomy or modified mastectomy. Adjuvant endocrine therapy of TAM or Fareston must be started within 6 weeks when adjuvant chemotherapy or radiotherapy was finished.

The full record lists 29 inclusion and 10 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

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.

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 2008-05 with completion listed for 2015-05.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: DFS (time frame: 5 Years).

It also tracked 6 secondary outcomes, for example OS, Time to distant metastasis, Bilateral secondary primary breast cancer morbidity, DDFS, Osteoporosis related events and Other adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 670 people.

With 670 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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