Premenopausal Endocrine Responsive Chemotherapy Trial

Summary

The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial \[recommended option\]. The trial was terminated early due to poor accrual.

Conditions

• Breast Cancer

Interventions

DRUG

chemotherapy

Planned duration of chemotherapy: 2 months if an anthracycline is included (e.g., 4 cycles of EC or AC) or 4 months if no anthracycline is given (e.g., 6 cycles of CMF) is recommended. Unless medically contraindicated, an anthracycline-containing regimen using epirubicin should be given.

DRUG

exemestane

Exemestane 25 mg orally daily for until 5 years from date of randomization, unless relapse or intolerance should occur earlier.

DRUG

tamoxifen

Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless relapse or intolerance should occur earlier.

DRUG

triptorelin

Triptorelin (GnRH analogue) 3.75 mg by intramuscular injection every 28 days for 5 years from randomization, unless relapse or intolerance should occur earlier or surgical oophorectomy or ovarian irradiation is subsequently performed.

PROCEDURE

oophorectomy

Bilateral surgical oophorectomy via laparotomy or laparoscopy.

PROCEDURE

ovarian irradiation

Bilateral ovarian irradiation.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Breast International Group

  collaborator OTHER

• ETOP IBCSG Partners Foundation

  lead NETWORK

Principal Investigators

• Rosalba Torrisi, MD · Breast International Group, European Institute of Oncology, Milano, Italy

• Edith A. Perez, MD · North American Intergroup, Mayo Clinic Jacksonville, Jacksonville, USA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-08-31

Primary Completion

2006-12-31

Completion

2006-12-31

Countries

• Hungary
• Italy
• Switzerland

Study Locations