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NCT00541086 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2020-02-07

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking use of estrogen by the tumor cells. Anastrozole, letrozole, and exemestane may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving tamoxifen followed by anastrozole, letrozole, or exemestane is more effective than giving anastrozole, letrozole, or exemestane alone in treating breast cancer. PURPOSE: This randomized phase III trial is studying giving tamoxifen followed by either anastrozole, letrozole, or exemestane to see how well it works compared to anastrozole, letrozole, or exemestane alone in treating postmenopausal women with hormone-responsive invasive breast cancer that has been completely removed by surgery.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Up-front adjuvant anastrozole for 5 years
    intervention Names
    1. Drug: anastrozole
    label
    A - anastrozole
    type
    EXPERIMENTAL
  2. description
    Up-front adjuvant exemestane for 5 years
    intervention Names
    1. Drug: exemestane
    label
    B - exemestane
    type
    EXPERIMENTAL
  3. description
    Up-front adjuvant letrozole for 5 years
    intervention Names
    1. Drug: letrozole
    label
    C - letrozole
    type
    EXPERIMENTAL
  4. description
    Switch adjuvant treatment with tamoxifen for 2 years followed by anastrozole for 3 years
    intervention Names
    1. Drug: anastrozole
    2. Drug: tamoxifen citrate
    label
    D - tamoxifen followed by anastrozole
    type
    ACTIVE_COMPARATOR
  5. description
    Switch adjuvant treatment with tamoxifen for 2 years followed by exemestane for 3 years
    intervention Names
    1. Drug: exemestane
    2. Drug: tamoxifen citrate
    label
    E - tamoxifen followed by exemestane
    type
    ACTIVE_COMPARATOR
  6. description
    Switch adjuvant treatment with tamoxifen for 2 years followed by letrozolefor 3 years
    intervention Names
    1. Drug: letrozole
    2. Drug: tamoxifen citrate
    label
    F - tamoxifen followed by letrozole
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. A - anastrozole
    2. D - tamoxifen followed by anastrozole
    description
    1 mg per day, orally
    name
    anastrozole
    type
    DRUG
  2. arm Group Labels
    1. B - exemestane
    2. E - tamoxifen followed by exemestane
    description
    25 mg per day, orally
    name
    exemestane
    type
    DRUG
  3. arm Group Labels
    1. C - letrozole
    2. F - tamoxifen followed by letrozole
    description
    2.5 mg per day, orally
    name
    letrozole
    type
    DRUG
  4. arm Group Labels
    1. D - tamoxifen followed by anastrozole
    2. E - tamoxifen followed by exemestane
    3. F - tamoxifen followed by letrozole
    description
    20 mg per day, orally
    name
    tamoxifen citrate
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
FACTORIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
3697
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Disease-free survival
    time Frame
    5 years
secondary Outcomes
  1. measure
    Overall Survival
    time Frame
    5 years
  2. measure
    Distant metastasis-free survival
    time Frame
    5 years
  3. measure
    Cumulative incidence of contralateral breast cancer as first event
    time Frame
    5 years
  4. measure
    Breast cancer-free survival
    time Frame
    5 years
  5. measure
    Cumulative incidence and type of second non-breast invasive cancer
    time Frame
    5 years
  6. measure
    Effects on lipid profile
    time Frame
    5 years
  7. measure
    Toxicity as assessed by NCI CTCAE v3.0
    time Frame
    5 years
Full study description
brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking use of estrogen by the tumor cells. Anastrozole, letrozole, and exemestane may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving tamoxifen followed by anastrozole, letrozole, or exemestane is more effective than giving anastrozole, letrozole, or exemestane alone in treating breast cancer. PURPOSE: This randomized phase III trial is studying giving tamoxifen followed by either anastrozole, letrozole, or exemestane to see how well it works compared to anastrozole, letrozole, or exemestane alone in treating postmenopausal women with hormone-responsive invasive breast cancer that has been completely removed by surgery.
detailed Description
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.
Source references
references
  1. citation
    De Placido S, Gallo C, De Laurentiis M, Bisagni G, Arpino G, Sarobba MG, Riccardi F, Russo A, Del Mastro L, Cogoni AA, Cognetti F, Gori S, Foglietta J, Frassoldati A, Amoroso D, Laudadio L, Moscetti L, Montemurro F, Verusio C, Bernardo A, Lorusso V, Gravina A, Moretti G, Lauria R, Lai A, Mocerino C, Rizzo S, Nuzzo F, Carlini P, Perrone F; GIM Investigators. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):474-485. doi: 10.1016/S1470-2045(18)30116-5. Epub 2018 Feb 23.
    pmid
    29482983
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        11;1.23; <em>P</em> = .45 and tamoxifen to letrozole HR, 1.07; 95% CI, 0.92&#8211;1.25; <em>P</em> = .36).</li></ul></div></li><li>The <a href="/clinicaltrials/NCT00541086">FATA-GIM3</a> trial (NCT00541086), which was not included in the meta-analysis, compared 2 years of tamoxifen followed by 3 years of one of the three AIs with
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        xifen to letrozole HR, 1.07; 95% CI, 0.92&#8211;1.25; <em>P</em> = .36).</li></ul></div></li><li>The <a href="/clinicaltrials/NCT00541086">FATA-GIM3</a> trial (NCT00541086), which was not included in the meta-analysis, compared 2 years of tamoxifen followed by 3 years of one of the three AIs with 5 years of an AI.[<a href="#cit/s
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      3. context exact
        planned 959 events. </li><li>There were no substantial differences in adverse events between the arms.</li></ul></div></li><li>In the <a href="/clinicaltrials/NCT00541086">FATA-GIM3</a> trial, 3,697 patients with hormone receptor&#8211;positive disease were randomly assigned among the three AIs either for 5 years or after 2 year
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      source title
      Breast Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025

    Preserved source evidence · Not medical advice