Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

What Was Tested

The trial (phase 3) is built around Goserelin.

It had two arms (groups): cyclophosphamide (active comparator) and Goserelin (Zoladex) (experimental).

Standard cyclophosphamide containing adjuvant or neoadjuvant chemotherapy.

Goserelin (Zoladex) plus Standard cyclophosphamide containing adjuvant or neoadjuvant chemotherapy.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 416 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Patients must have tumors that are both estrogen receptor negative and progesterone receptor negative. Patients must be of age 18 or greater and under age 50. The patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based. For patients receiving chemotherapy in the pre-operative setting, there must be no intention to give additional chemotherapy in the postoperative setting. Patients must not have received prior cytotoxic chemotherapy for this breast cancer or for any condition. Patients currently enrolled on S0221 are eligible for this study.

The full record lists 11 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, single-group and open-label.

Because people in this Goserelin 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 Goserelin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-11 with completion listed for 2012-11.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The study is to compare the rate of premature ovarian failure at two years following standard adjuvant or neoadjuvant chemotherapy (time frame: Three years).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 416 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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