Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin.

It had four arms (groups): Arm I (experimental), Arm II (experimental), Arm III (experimental) and Arm IV (experimental).

Patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.

Patients who had CIA receive toremifene as in arm I.

Patients without CIA receive oral toremifene and goserelin for ovarian function suppression.

The registry classes the interventions as drug.

More on the Plan

This is a single center, randomized, controlled study.

Patients undergo surgical resection with standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T).

Chemotherapy begins within 4 weeks after surgery for patients randomized to arm I-IV.

Arm I: patients who didn't have CIA receive oral toremifene daily.

Who Took Part

The registry lists 300 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures. Age of at least 18 and at most 45 years. Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase. Histologically confirmed primary breast cancer with the need for anthracycline-based chemotherapy. Life expectancy of at least 10 years, disregarding the diagnosis of cancer.

The full record lists 11 inclusion and 8 exclusion criteria; among the exclusions: known hypersensitivity reaction to the investigational compounds or incorporated substances; prior cytotoxic treatment for any reason; suspected (primary or secondary) ovarian insufficiency.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

Neither the participants nor the staff measuring them knew who was on Goserelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-05 with completion listed for 2024-05.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Disease free survival (time frame: up to 120 months). Overall Survival (time frame: up to 120 months).

It also tracked 4 secondary outcomes, for example Quality of life, Bone mineral density loss, Hormone levels and Incidence of pregnancy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 300 people.

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.