Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer

What Was Tested

The trial (phase 2) is built around Goserelin.

It had three arms (groups): one (experimental), one (experimental) and Group 3 (E2 > 15 pg/ml) (experimental).

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 8 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: Patient must have a negative serum pregnancy test within 7 days of registration. Patient's primary tumor must be palpable and measure \> 2 cm by tape, ruler or caliper measurements in at least one dimension. Patient, as documented by the treating physician, must be clinically staged as one of the following:. T4 a-c for which modified radical mastectomy with negative margins is the goal. T2 or T3 for which conversion from needing mastectomy to breast conservation is the goal.

The full record lists 30 inclusion and 10 exclusion criteria; among the exclusions: patient must not have had prior dcis in the ipsilateral breast; patient must not have used tamoxifen for prior contralateral dcis; if patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant therapy, she is ineligible for this study.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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 2011-09 with completion listed for 2013-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathologic Complete Response (CR) Rate (time frame: 1 month). Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy (time frame: 6 months post neoadjuvant endocrine therapy and surgery).

It also tracked 3 secondary outcomes, for example Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67 and Preoperative Endocrine Prognostic Index Score (PEPI Score).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Goserelin in 8 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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