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Breast CancerPhase 3GIM10-CONSENTNCT02918084

CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer

A Phase 3 study testing Anastrozole or Letrozole or Exemestane in people with Breast Cancer, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 74 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet. 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 or Letrozole or Exemestane
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
74 sitesItaly
Study dates
Jun 2013to Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N.
  • Postmenopausal status defined by at least one of the following conditions:
  • Aged ≥ 60
  • Aged 45-59 and satisfying one or more of the following criteria:
  • amenorrhea for ≥12 months and intact uterus;
  • amenorrhea for <12 months and follicle-stimulating hormone (FSH) within the postmenopausal range, including:
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  • pts with hysterectomy
  • pts who have received hormone replacement therapy (HRT)
  • pts with chemotherapy-induced amenorrhea
  • bilateral oophorectomy at any age >18 years.
  • Primary tumor positive for Estrogen Receptors (ER) and/or Progesteron receptors (PgR) (≥1% tumor cells positive by immunohistochemistry or ≥ 10 fmol/mg cytosol protein by ligand binding assay).
  • Patients who are prescribed 5 years of endocrine therapy with an aromatase inhibitors (AI)
  • Indication for adjuvant chemotherapy- Patients with HER-2 positive tumors are eligible provided that they are prescribed trastuzumab according to registered schedule.
  • Signed informed consent.

Who cannot join

  • HRT currently assumed or during the month before randomization
  • Recurrent or metastatic disease
  • HER-2 positive tumors if treatment with trastuzumab is considered not appropriate/feasible
  • Concurrent illness that contraindicate adjuvant endocrine treatment and/or chemotherapy
  • Patients who have received Tamoxifen as part of any breast cancer prevention trial
  • Previous history of invasive breast cancer or other invasive malignancy within the previous 10 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
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  • Concomitant severe disease which would place the patient at unusual risk
  • Concurrent treatment with experimental drugs
  • Patients treated with systemic investigational drugs within the past 30 days

Trial locations and contacts

74 sites in 1 country.

74 sites in 1 country

Italy74 sites

  • A.O. San Giuseppe Moscati

    Avellino, AV, 83100

  • Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico

    Bari, BA, 70124

  • Azienda Ospedaliera G. Rummo

    Benevento, BN, 82100

  • Ospedale Fatebenefratelli 'Sacro Cuore di Gesù'

    Benevento, BN, 82100

  • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII

    Bergamo, BG, 24127

  • ASST Spedali Civili - P.O. Spedali Civili

    Brescia, BS, 25123

  • Presidio Ospedaliero 'Antonio Perrino'

    Brindisi, BR, 72100

  • Ospedale Civile di Campobasso - A. Cardarelli

    Campobasso, CB, 86100

  • Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo

    Candiolo, TO, 10060

  • Ospedale Santo SpiritoH

    Casale Monferrato, AL, 15033

  • Humanitas Centro Catanese di Oncologia

    Catania, CT, 95126

  • Ospedale Clinicizzato 'S. Annunziata' - Università degli Studi 'G. d'Annunzio'

    Chieti, CH, 66100

  • Ospedale Civile di Città di Castello - A.S.L. n. 1

    Città di Castello, PG, 06012

  • ASST Lariana - Ospedale S. Anna

    Como, CO, 22100

  • Arcispedale S. Anna - A.O.U. di Ferrara

    Cona, FE, 44124

  • Ospedale San Sebastiano

    Correggio, RE, 42015

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, CN, 12100

  • Ospedale di Rete 'Engles Profili' - A.S.U.R. Area Vasta 2

    Fabriano, AN, 60044

  • Ospedale per gli Infermi

    Faenza, RA, 48018

  • Ospedale Santa Croce - A.O. Ospedali Riuniti Marche Nord

    Fano, PS, 61032

  • A.O.U. Careggi

    Florence, FI, 50134

  • AUSL di Frosinone - Ospedale Fabrizio Spaziani

    Frosinone, FR, 03100

  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

    Genoa, GE, 16132

  • E.O. Ospedali Galliera

    Genova, GE, 16128

  • ASST Melegnano e della Martesana - Ospedale Serbelloni

    Gorgonzola, MI, 20064

  • Azienda U.S.L. N. 9 - Ospedale Misericordia

    Grosseto, GR, 58100

  • Ospedale Civile di Guastalla

    Guastalla, RE, 42016

  • Azienda Sanitaria Regionale Molise - Ospedale F. Veneziale - Zona di Isernia

    Isernia, IS, 86170

  • Ospedale Civile Renzetti

    Lanciano, CH, 66034

  • Ospedale Vietri

    Larino, CB, 80035

  • A.S.L. LT - Ospedale Santa Maria Goretti

    Latina, LT, 04100

  • Ospedale Vito Fazzi

    Lecce, LE, 73100

  • ASST Ovest Milanese - Ospedale Nuovo di Legnano

    Legnano, MI, 20025

  • Ospedale Unico Versilia

    Lido di Camaiore, LU, 55041

  • Ospedale San Luca

    Lucca, LU, 55100

  • Ospedale Umberto I

    Lugo, RA, 48022

  • Azienda Ospedaliera Carlo Poma

    Mantua, MN, 46100

  • IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

    Meldola, FC, 47014

  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico

    Milan, MI, 20121

  • Istituto Europeo di Oncologia (IRCCS)

    Milan, MI, 20141

  • A.O.U. Policlinico Modena

    Modena, MO, 41124

  • ASST Monza - Ospedale San Gerardo

    Monza, MB, 20052

  • A.O.U. Federico II

    Naples, 80131

  • Azienda Ospedaliera 'A. Cardarelli' (AORN)

    Naples, 80131

  • Istituto Nazionale dei Tumori - Fondazione G.Pascale

    Naples, 80131

  • Ospedale Sacro Cuore Don Calabria

    Negrar, VE, 37024

  • Ospedale Civile 'Gaetano Bernabeo'

    Ortona, CH, 66026

  • Istituto Oncologico Veneto - I.R.C.C.S.

    Padova, PD, 35128

  • A.O.U. Policlinico 'Paolo Giaccone'

    Palermo, PA, 90129

  • Azienda Ospedaliera Universitaria di Parma

    Parma, PR, 43100

  • Fondazione S. Maugeri IRCCS

    Pavia, PV, 27100

  • Ospedale Civile 'San Massimo'

    Penne, PE, 65017

  • Ospedale S. Maria della Misericordia

    Perugia, PG, 06132

  • Ospedale 'Guglielmo da Saliceto'

    Piacenza, PC, 29121

  • A.O.U. Pisana - Ospedale Santa Chiara

    Pisa, PI, 56126

  • Ospedale Felice Lotti - Azienda USL 5 di Pisa

    Pontedera, PI, 56025

  • Azienda Ospedaliera S. Carlo

    Potenza, PZ, 85100

  • Ospedale di Macerata

    Province of Macerata, MC, 62100

  • Azienda Ospedaliera Bianchi - Melacrino - Morelli

    Reggio Calabria, RC, 89125

  • IRCCS A.O. S.Maria Nuova

    Reggio Emilia, RE, 42123

  • Policlinico Umberto I

    Roma, PM, 00186

  • Istituto Regina Elena per lo studio e la cura dei tumori

    Roma, RM, 00144

  • Ospedale S. Eugenio

    Roma, RM, 00144

  • Azienda Ospedaliera San Camillo - Forlanini

    Roma, RM, 00149

  • Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina

    Roma, RM, 00186

  • A.O. S. Andrea - Università 'La Sapienza' - II Facoltà di Medicina e Chirurgia

    Roma, RM, 00189

  • IRCCS 'Casa Sollievo della Sofferenza'

    San Giovanni Rotondo, FG, 71013

  • ASST della Valle Olona - Ospedale di Saronno

    Saronno, VA, 21047

  • Azienda Ospedaliera n. 1 - Annunziata

    Sassari, SS, 07100

  • AUSL di Frosinone - Ospedale SS. Trinità

    Sora, FR, 03039

  • Ospedale S. Anna - A.O.U. Città della Salute e della Scienza

    Torino, TO, 10126

  • Ospedale S. Anna - Città della salute

    Torino, TO, 10126

  • Azienda Ospedaliera Treviglio-Caravaggio

    Treviglio, BG, 24047

  • Ospedale Belcolle - AUSL di Viterbo

    Viterbo, VT, 01100

Other trials in Italy

About this study

Official title: A Phase III Study Comparing the Concurrent Versus the Sequential Administration of Chemotherapy and Aromatase Inhibitors, as Adjuvant Treatment of Post-menopausal Patients With Endocrine-responsive Early Breast Cancer.

Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet.

Read the detailed description

Breast cancer is the most common form of cancer among women in North America, Europe and Latin America. Because nearly 80% of breast cancers are endocrine-responsive tumors, the majority of patients candidates for adjuvant chemotherapy (CT) are also candidates for endocrine therapy (ET). The optimal timing (i.e. concomitant vs sequential administration) for the integration of these two treatments has not been clearly defined yet.

In patients with hormone receptor positive early stage breast cancer who are candidates to adjuvant chemotherapy and endocrine therapy, the optimal timing for the integration of these two treatment modalities has not been clearly defined yet.

Conditions
Breast Cancer
Being tested
Anastrozole or Letrozole or Exemestane
Keywords
sequential administration chemiotherapy, early breast cancer, breast cancer, aromatase inhibitor, adjuvant, post menopausal
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Anastrozole or Letrozole or ExemestaneDrug

    Also called Clinical Practice

    Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)

  • Anastrozole or Letrozole or ExemestaneDrug

    Also called Experimental arm

    Adjuvant chemotherapy + Anastrozole or Letrozole or Exemestane once a day for 5 years (concurrent arm)

Study groups in NCT02918084
Study groupRoleWhat they receive
ARM ASham comparatorAdjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm)
Receives: Drug: Anastrozole or Letrozole or Exemestane
ARM BExperimentalAdjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm)
Receives: Drug: Anastrozole or Letrozole or Exemestane

What is being measured

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

  1. Disease- free Survival (DFS)

    the primary outcome indicator will be the so called DFS, defined as time elapsing between the date of randomization and the date of one of the following events, whichever occurs first, assessed up to 15 years:

    • Local Recurrence of disease
    • Regional recurrence of disease
    • Distant recurrence of disease
    • Contralateral invasive or intraductal breast cancer
    • Second primary malignancy other than breast
    • Death for any cause

    Measured: up to 15 years

Secondary outcomes (4)

  1. Overall Survival (OS)

    Measured: time between the date of randomization up to the date of death for any cause, assessed up to 15 years.

  2. Translational Study: genomic analysis

    Expression of genes associated with ER and Ki67 expression will be analyzed by Real Time polymerase chain reaction (PCR) on RNA extracted from formalin-fixed paraffin embedded (FFPE) sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive) and will be correlated with disease free survival.

    Measured: up to 15 years

  3. Translational Study: epigenetic analysis

    miRNA expression analysis by real time PCR and DNA methylation analysis by pyrosequencing will be assessed on FFPE sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive)

    Measured: up to 15 years

  4. Translational Study: proteomic analysis

    The different proteomic profiles identified in FFPE sections of hormone receptors positive G2 tumors will be correlated with DFS

    Measured: up to 15 years

Timeline

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

  1. First posted28 Sep 2016 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (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
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02918084
Sponsor's protocol ID
GIM10-CONSENT
Other IDs
2013-001629-23
Acronym
GIM10-CONSENT
Status last verified
Apr 2026
First submitted
16 Sep 2016
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anastrozole or Letrozole or Exemestane in people with Breast Cancer, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 74 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?

The sponsor lists 14 inclusion and 9 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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 (DFS) (time frame: up to 15 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 NCT02918084.

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 6 May 2026.

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