A follow-up study of a randomized controlled study evaluating safety and efficacy of leuprorelin acetate every-3-month depot for 2 versus 3 or more years with tamoxifen for 5 years as adjuvant treatment in premenopausal patients with endocrine-responsive breast cancer

What Was Tested

Researchers studied Leuprolide in this randomized controlled trial publication.

Previously, the researchers conducted the 5-year open-label, randomized controlled trial (RCT) of leuprorelin adjuvant therapy in post-operative premenopausal patients with endocrine-responsive breast cancer, which was a pilot study to investigate the optimal duration of leuprorelin treatment.

Why It Was Studied

Since, however, long-term outcomes became required for the adjuvant endocrine therapy, the researchers performed this follow-up observation study.

This was an observational study.

Who Took Part

PubMed tags the participants as women only.

How the Study Was Run

In design terms this was a randomized, open-label and pilot study.

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

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

It is described as a pilot, a small early test of whether a larger Leuprolide study would be practical.

Primary endpoints were disease-free survival (DFS) and 2-year landmark DFS.

What Was Measured

Since, however, long-term outcomes became required for the adjuvant endocrine therapy, the researchers performed this follow-up observation study.

The subject headings attached to it are Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Chemotherapy, Adjuvant, Leuprolide, Premenopause and Tamoxifen.

Author keywords: Adjuvant endocrine therapy, Endocrine-responsive breast cancer, LH-RH agonist, Ovarian function suppression and Premenopausal patient.

What This Means in Plain Language

The paper is a randomized, open-label and pilot study of Leuprolide.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2021 (Breast cancer (Tokyo, Japan)), a journal based in Japan.

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