Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Study of Anastrozole, Letrozole, or Exemestane With or Without Tamoxifen in Treating Postmenopausal Women With Hormone-Responsive Breast Cancer That Has Been Completely Removed By Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Over 18	Other	GIM-3-FATA GIM3-FATA, EUDRACT-2006-004018-42, EU-20764, NCT00541086

Objectives

1. To compare sequential tamoxifen for 2 years followed by anastrozole, letrozole, or exemestane for 3 years vs anastrozole, letrozole, or exemestane for 5 years in terms of disease-free survival in postmenopausal women with nonrecurrent, nonmetastatic invasive endocrine-responsive breast cancer.
2. To compare disease-free survival in patients treated with anastrozole vs letrozole vs exemestane.

Entry Criteria

Disease Characteristics:

• Histologically confirmed invasive breast cancer completely removed by surgery
  • Any T, any N
  • No recurrent or metastatic disease



• Estrogen or progesterone receptor-positive disease in primary tumor, as defined by 1 of the following:
  • At least 10% of tumor cells positive by immunohistochemistry
  • At least 10 fmol/mg cytosol protein by ligand binding assay



• Patients with HER-2/neu positive tumors are eligible provided they receive trastuzumab (Herceptin®) according to the registered schedule

Prior/Concurrent Therapy:

• See Disease Characteristics
• Adjuvant or neoadjuvant chemotherapy must be completed prior to study entry
• At least 1 month since prior and no concurrent HRT
• More than 30 days since prior systemic investigational drugs
• No prior tamoxifen as part of any breast cancer prevention study
• Prior or concurrent locoregional radiotherapy allowed
• No other concurrent experimental drugs
• No concurrent bisphosphonates, unless indicated as treatment for osteoporosis

Patient Characteristics:

• Female
• Postmenopausal, defined by ≥ 1 of the following:
  • Age ≥ 60 years
  • Age 45-59 and satisfying 1 or more of the following criteria:
    • Amenorrhea for ≥ 12 months AND intact uterus
    • Amenorrhea (secondary to hysterectomy, hormone replacement therapy (HRT), or chemotherapy) for < 12 months AND follicle-stimulating hormone within the postmenopausal range
  • Underwent prior bilateral oophorectomy at any age >18 years
• No concurrent illness that contraindicates adjuvant endocrine treatment
• No other invasive breast cancer or invasive malignancy within the past 10 years, except adequately cone-biopsied squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
• No concurrent disease that would place the patient at unusual risk

Expected Enrollment

Outcomes

Disease-free survival

Overall Survival
Distant metastasis-free survival
Cumulative incidence of contralateral breast cancer as first event
Breast cancer-free survival
Cumulative incidence and type of second non-breast invasive cancer
Effects on lipid profile
Toxicity as assessed by NCI CTCAE v3.0

Outline

This is a multicenter study. Patients are stratified according to hormone receptor status (estrogen receptor [ER]-positive and progesterone [PgR] receptor-positive disease vs ER-positive and PgR-negative disease vs ER-negative and PgR-positive disease vs ER- or PgR-positive disease or ER or PgR status unknown), HER-2/neu status (positive [3+ by IHC or positive by fluorescence in situ hybridization ( FISH)] vs negative vs unknown), prior chemotherapy (none vs adjuvant vs neoadjuvant vs both adjuvant and neoadjuvant), and nodal status (pN0 vs pN1 vs pN2 vs pN3). Patients are randomized to 1 of 6 treatment arms.

• Arm I: Patients receive oral anastrozole once daily for 5 years.



• Arm II: Patients receive oral exemestane once daily for 5 years.



• Arm III: Patients receive oral letrozole once daily for 5 years.



• Arm IV: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral anastrazole once daily for 3 years.



• Arm V: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral exemestane once daily for 3 years.



• Arm VI: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral letrozole once daily for 3 years.

Treatment in all arms continues in the absence of disease recurrence or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Trial Contact Information

Trial Lead Organizations

Gruppo Italiano Mammella

Sabino De Placido, MD, Protocol chair		Ph: 39-081-746-2062-746 Email: deplacid@unina.it

Italy
	Naples
	Federico II University Medical School
		Sabino De Placido, MD	Ph:  39-081-746-3660
			Email: deplacid@unina.it
	Istituto Nazionale per lo Studio e la Cura dei Tumori
		Francesco Perrone, MD	Ph:  39-81-590-3571
	Seconda Universita di Napoli
		Ciro Gallo	Ph:  39-81-566-6021
	Reggio Emilia
	Arcispedale S. Maria Nuova
		Corrado Boni, MD	Ph:  39-522-296-546
			Email: boni.corrado@asmn.re.it
	Rome
	Istituti Fisioterapici Ospitalieri - Roma
		Francesco Cognetti, MD	Ph:  39-06-5266-6919
			Email: cognetti@ifo.it

Registry Information
Official Title		A phase III study comparing anastrozole, letrozole and exemestane, upfront (for 5 years) or sequentially (for 3 years after 2 years of tamoxifen), as adjuvant treatment of postmenopausal patients with endocrine-responsive breast cancer
Trial Start Date		2007-03-12
Trial Completion Date		2016-03-12 (estimated)
Registered in ClinicalTrials.gov		NCT00541086
Date Submitted to PDQ		2007-09-12
Information Last Verified		2007-10-28

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