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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


OBJECTIVES:

- 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.

- To compare disease-free survival in patients treated with anastrozole vs letrozole vs
exemestane.

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Sabino De Placido, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Federico II University

Authority:

Unspecified

Study ID:

CDR0000570041

NCT ID:

NCT00541086

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • estrogen receptor-positive breast cancer
  • progesterone receptor-positive breast cancer
  • Breast Neoplasms

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