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Breast CancerPhase 3NCT00541086

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

A Phase 3 study testing anastrozole, exemestane and letrozole in people with Breast Cancer, run by Gruppo Italiano Mammella (GIM) at 5 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
anastrozole, exemestane and letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,697 participants
Where
5 sitesItaly
Study dates
Mar 2007to Jul 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Italy5 sites

  • Federico II University Medical School

    Naples, 80131

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Naples, 80131

  • Seconda Universita di Napoli

    Naples, 80138

  • Arcispedale S. Maria Nuova

    Reggio Emilia, 42100

  • Istituti Fisioterapici Ospitalieri - Roma

    Rome, 00128

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
anastrozole, exemestane, letrozole, tamoxifen citrate
Keywords
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
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anastrozoleDrug

    1 mg per day, orally

  • exemestaneDrug

    25 mg per day, orally

  • letrozoleDrug

    2.5 mg per day, orally

  • tamoxifen citrateDrug

    20 mg per day, orally

Study groups in NCT00541086
Study groupRoleWhat they receive
A - anastrozoleExperimentalUp-front adjuvant anastrozole for 5 years
Receives: Drug: anastrozole
B - exemestaneExperimentalUp-front adjuvant exemestane for 5 years
Receives: Drug: exemestane
C - letrozoleExperimentalUp-front adjuvant letrozole for 5 years
Receives: Drug: letrozole
D - tamoxifen followed by anastrozoleActive comparatorSwitch adjuvant treatment with tamoxifen for 2 years followed by anastrozole for 3 years
Receives: Drug: anastrozole; Drug: tamoxifen citrate
E - tamoxifen followed by exemestaneActive comparatorSwitch adjuvant treatment with tamoxifen for 2 years followed by exemestane for 3 years
Receives: Drug: exemestane; Drug: tamoxifen citrate
F - tamoxifen followed by letrozoleActive comparatorSwitch adjuvant treatment with tamoxifen for 2 years followed by letrozolefor 3 years
Receives: Drug: letrozole; Drug: tamoxifen citrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    Measured: 5 years

Secondary outcomes (7)

  1. Overall Survival

    Measured: 5 years

  2. Distant metastasis-free survival

    Measured: 5 years

  3. Cumulative incidence of contralateral breast cancer as first event

    Measured: 5 years

  4. Breast cancer-free survival

    Measured: 5 years

  5. Cumulative incidence and type of second non-breast invasive cancer

    Measured: 5 years

  6. Effects on lipid profile

    Measured: 5 years

  7. Toxicity as assessed by NCI CTCAE v3.0

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionJul 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
3,697 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00541086
Sponsor's protocol ID
CDR0000570041
Other IDs
GIM-3-FATA, EUDRACT-2006-004018-42, EU-20764
Status last verified
Feb 2020
First submitted
5 Oct 2007
Last updated
7 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29482983

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing anastrozole, exemestane and letrozole in people with Breast Cancer, run by Gruppo Italiano Mammella (GIM) at 5 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00541086, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.

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