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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00541086
• Date of registration: 05/10/2007
• Primary sponsor: Gruppo Italiano Mammella (GIM)
• Public 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
• Scientific 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
• Date of first enrolment: March 2007
• Target sample size: 10000
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00541086
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy

Contacts

• Name: Sabino De Placido, MD
• Affiliation: Federico II University

Key inclusion & exclusion 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

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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: anastrozole

Drug: exemestane

Drug: letrozole

Drug: tamoxifen citrate

Procedure: adjuvant therapy

Primary Outcome(s)

Disease-free survival [Time Frame: No]

Secondary Outcome(s)

Breast cancer-free survival [Time Frame: No]

Cumulative incidence and type of second non-breast invasive cancer [Time Frame: No]

Cumulative incidence of contralateral breast cancer as first event [Time Frame: No]

Distant metastasis-free survival [Time Frame: No]

Effects on lipid profile [Time Frame: No]

Overall Survival [Time Frame: No]

Toxicity as assessed by NCI CTCAE v3.0 [Time Frame: Yes]

Secondary ID(s)

CDR0000570041

EU-20764

EUDRACT-2006-004018-42

GIM-3-FATA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors