Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women

What Was Tested

The trial (phase 3) is built around Leuprolide and Goserelin.

The objective of this study is to compare the curative effects in patients under the age of 35 with hormone receptor positive breast cancer and high recurrent risk factors including large tumor or metastatic lymph nodes randomized to ovarian function suppression (OFS) plus aromatase inhibitors or OFS plus tamoxifen as adjuvant endocrine therapy, and explore the differences of curative effects between different subtypes to provide direct evidence for treatments of young breast cancer patients.

It had two arms (groups): Ovarian Suppression and aromatase inhibitors (experimental) and Ovarian Suppression and tamoxifen (active comparator).

The registry classes the interventions as drug.

Who Took Part

680 planned participants were the target.

It was open to women only aged up to 35 years.

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

Examples of who could join: Signed informed consent;. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;. Premenopausal patients with age ≤35 years (at least menstruate once for prior 3 months, assess menstruation situation before chemotherapy if have);. No distant metastasis;. Clinical stage (TNM) meets at least one of the conditions as follow: T≥2cm or at least one region of regional lymph node metastasis (including micrometastases);.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: pregnant or lactating women or women of childbearing potential reject contraceptive measures;; history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);; prior use of neo-adjuvant chemotherapy after a definite diagnosis;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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

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

It started in 2016-03-30 with completion listed for 2023-12-30.

It ran at 25 sites in China (25).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Disease-Free Survival (DFS) (time frame: 5 years).

It also tracked 3 secondary outcomes, for example Overall Survival (OS), Invasive Breast Cancer Recurrence-Free Interval（BCFI) and Adverse Effects Rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Goserelin in 680 people.

With 680 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 Leuprolide compound page and the Goserelin compound page, all human trials.