Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Anti-Infective Agents

Tamoxifen

Exemestane

Epirubicin

Triptorelin Pamoate

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Aromatase Inhibitors

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.

Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.

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.

chemotherapy

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

exemestane

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

tamoxifen

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.

triptorelin

Bilateral surgical oophorectomy via laparotomy or laparoscopy.

oophorectomy

ovarian irradiation

Rosalba Torrisi, MD

Edith A. Perez, MD

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.

OBJECTIVES:

* Compare ovarian function suppression and tamoxifen or exemestane with vs without adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast cancer.
* Compare the disease-free and overall survival of patients treated with these regimens.
* Compare sites of first treatment failure in patients treated with these regimens.
* Compare the incidence of second nonbreast malignancies in patients treated with these regimens.
* Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.

PLANNED OUTLINE:

This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more), method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation), chemotherapy if randomized to arm II (not containing vs containing an anthracycline or taxane), and endocrine agent (tamoxifen vs exemestane vs selected by subsequent randomization in the TEXT trial). Treatment duration is five years.

Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

NOTE: Trial was terminated early due to poor accrual.

Premenopausal Endocrine Responsive Chemotherapy Trial

A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women With Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy

National Cancer Institute (NCI)

Breast International Group

ETOP IBCSG Partners Foundation

CAVEAT: Trial was terminated early; data available ONLY for selected Grade 3-5 adverse events for chemotherapy arm. Systematic assessment included form with specific AEs related to chemotherapy. 25 out of 29 patients were co-enrolled in TEXT (IBCSG 25-02) and AEs associated with endocrine therapy are reported as part of that trial.

OFS Plus T or E for 5 Years

Chemotherapy Plus OFS Plus T or E for 5 Years

Total

Age, Continuous

Sex: Female, Male

Trial terminated early due to poor accrual. Adverse event data is available ONLY for selected Grade 3-5 AEs for chemotherapy arm. 25 of 29 patients were co-enrolled in TEXT (IBCSG 25-02), which reports AEs and outcomes of endocrine therapy.

Rudolf Maibach, Executive Officer for International Trial Activities

The trial was terminated early due to poor accrual. No outcome measure data is available.

Spots Global Cancer Trial Database for ovarian irradiation