Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin.

The registry classes the interventions as drug and procedure.

More on the Plan

OBJECTIVES: Primary * To measure overall response rate (ORR) in premenopausal women treated with an aromatase inhibitor (AI) and ovarian suppression (OS).

OUTLINE: This is a pilot, open-label study.

Patients undergo surgical ovarian suppression (OS) or medical OS with luteinizing hormone-releasing hormone (LHRH) agonist (i.e., goserelin or leuprolide acetate, intramuscularly once monthly for 3 months and then every 2 months thereafter for the duration of study therapy).

Beginning on day 14 after initiation of LHRH-agonist therapy or surgery, patients receive oral letrozole once daily.

Who Took Part

1 actual participants took part.

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: Histologically confirmed carcinoma of the breast. Measurable disease (i.e., unidimensional by RECIST). No rapidly progressing visceral involvement (e.g., liver or lymphangitic lung disease). No known marrow involvement as evidenced by diffuse uptake by imaging studies or bone marrow biopsy or aspirate. No evidence of CNS metastases.

The full record lists 42 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a open-label study.

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

It started in 2007-02 with completion listed for 2007-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Overall response rate as measured by RECIST.

It also tracked 10 secondary outcomes, for example Time to treatment failure, Time to progression, Qualitative and quantitative toxicity as assessed by NCI CTCAE v3.0, Disease-free survival, Overall survival and Safety.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide and Goserelin in 1 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); 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.