Premenopausal Endocrine Responsive Chemotherapy Trial

PHASE3TerminatedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

August 31, 2003

Primary Completion Date

December 31, 2006

Study Completion Date

December 31, 2006

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.

Trial Locations (6)

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1122

National Institute of Oncology, Budapest

20141

European Institute of Oncology, Milan

33081

Centro di Riferimento Oncologico - Aviano, Aviano

CH-7000

Kantonsspital Graubuenden, Chur

CH-9007

Kantonsspital - St. Gallen, Sankt Gallen

Sponsors
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Breast International Group

OTHER

lead

ETOP IBCSG Partners Foundation

NETWORK

NCT00066807 - Premenopausal Endocrine Responsive Chemotherapy Trial | Biotech Hunter | Biotech Hunter