Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

What Was Tested

The trial (phase 3) is built around Triptorelin.

RATIONALE: Chemotherapy may cause early menopause in premenopausal women.

The registry classes the interventions as drug and procedure.

More on the Plan

OBJECTIVES: Primary * Evaluate the incidence of chemotherapy-induced early menopause in premenopausal women undergoing adjuvant chemotherapy in combination with vs without triptorelin for previously resected stage I-III breast cancer.

Secondary * Compare the toxicity of adjuvant chemotherapy and triptorelin vs adjuvant chemotherapy alone.

OUTLINE: This is a prospective, open-label, multicenter, randomized study.

Patients with hormone-sensitive tumors who resume ovarian function after stopping chemotherapy and triptorelin restart triptorelin until ovarian function is suppressed for 2 years.

Who Took Part

280 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Histologically or cytologically confirmed breast cancer resected at time of original diagnosis. Stage I-III disease. Candidate for 1 of the following adjuvant chemotherapy regimens:. FEC (fluorouracil, epirubicin hydrochloride, and cyclophosphamide) every 21 or 28 days. CMF (cyclophosphamide, methotrexate, and fluorouracil) every 28 days.

The full record lists 24 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized and open-label.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

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

It started in 2003-09 with completion listed for 2008-01.

It ran at 18 sites in Italy (18).

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy.

It also tracked 1 secondary outcome, for example Toxicity as measured by Common Toxicity Criteria at each chemotherapy course.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 280 people.

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

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