CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer (GIM10-CONSENT)

April 29, 2026 updated by: Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • A.O.U. Federico II
      • Naples, Italy, 80131
        • Azienda Ospedaliera 'A. Cardarelli' (AORN)
      • Naples, Italy, 80131
        • Istituto Nazionale dei Tumori - Fondazione G.Pascale
    • AL
      • Casale Monferrato, AL, Italy, 15033
        • Ospedale Santo SpiritoH
    • AN
      • Fabriano, AN, Italy, 60044
        • Ospedale di Rete 'Engles Profili' - A.S.U.R. Area Vasta 2
    • AV
      • Avellino, AV, Italy, 83100
        • A.O. San Giuseppe Moscati
    • BA
      • Bari, BA, Italy, 70124
        • Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico
    • BG
      • Bergamo, BG, Italy, 24127
        • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
      • Treviglio, BG, Italy, 24047
        • Azienda Ospedaliera Treviglio-Caravaggio
    • BN
      • Benevento, BN, Italy, 82100
        • Azienda Ospedaliera G. Rummo
      • Benevento, BN, Italy, 82100
        • Ospedale Fatebenefratelli 'Sacro Cuore di Gesù'
    • BR
      • Brindisi, BR, Italy, 72100
        • Presidio Ospedaliero 'Antonio Perrino'
    • BS
      • Brescia, BS, Italy, 25123
        • ASST Spedali Civili - P.O. Spedali Civili
    • CB
      • Campobasso, CB, Italy, 86100
        • Ospedale Civile di Campobasso - A. Cardarelli
      • Larino, CB, Italy, 80035
        • Ospedale Vietri
    • CH
      • Chieti, CH, Italy, 66100
        • Ospedale Clinicizzato 'S. Annunziata' - Università degli Studi 'G. d'Annunzio'
      • Lanciano, CH, Italy, 66034
        • Ospedale Civile Renzetti
      • Ortona, CH, Italy, 66026
        • Ospedale Civile 'Gaetano Bernabeo'
    • CN
      • Cuneo, CN, Italy, 12100
        • Azienda Ospedaliera S. Croce e Carle
    • CO
      • Como, CO, Italy, 22100
        • ASST Lariana - Ospedale S. Anna
    • CT
      • Catania, CT, Italy, 95126
        • Humanitas Centro Catanese Di Oncologia
    • FC
      • Meldola, FC, Italy, 47014
        • IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
    • FE
      • Cona, FE, Italy, 44124
        • Arcispedale S. Anna - A.O.U. di Ferrara
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • IRCCS 'Casa Sollievo della Sofferenza'
    • FI
      • Florence, FI, Italy, 50134
        • A.O.U. Careggi
    • FR
      • Frosinone, FR, Italy, 03100
        • AUSL di Frosinone - Ospedale Fabrizio Spaziani
      • Sora, FR, Italy, 03039
        • AUSL di Frosinone - Ospedale SS. Trinità
    • GE
      • Genoa, GE, Italy, 16132
        • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
      • Genova, GE, Italy, 16128
        • E.O. Ospedali Galliera
    • GR
      • Grosseto, GR, Italy, 58100
        • Azienda U.S.L. N. 9 - Ospedale Misericordia
    • IS
      • Isernia, IS, Italy, 86170
        • Azienda Sanitaria Regionale Molise - Ospedale F. Veneziale - Zona di Isernia
    • LE
      • Lecce, LE, Italy, 73100
        • Ospedale Vito Fazzi
    • LT
      • Latina, LT, Italy, 04100
        • A.S.L. LT - Ospedale Santa Maria Goretti
    • LU
      • Lido di Camaiore, LU, Italy, 55041
        • Ospedale Unico Versilia
      • Lucca, LU, Italy, 55100
        • Ospedale San Luca
    • MB
      • Monza, MB, Italy, 20052
        • ASST Monza - Ospedale San Gerardo
    • MC
      • Macerata, MC, Italy, 62100
        • Ospedale Di Macerata
    • MI
      • Gorgonzola, MI, Italy, 20064
        • ASST Melegnano e della Martesana - Ospedale Serbelloni
      • Legnano, MI, Italy, 20025
        • Asst Ovest Milanese - Ospedale Nuovo Di Legnano
      • Milan, MI, Italy, 20121
        • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico
      • Milan, MI, Italy, 20141
        • Istituto Europeo di Oncologia (IRCCS)
    • MN
      • Mantua, MN, Italy, 46100
        • Azienda Ospedaliera Carlo Poma
    • MO
      • Modena, MO, Italy, 41124
        • A.O.U. Policlinico Modena
    • PA
      • Palermo, PA, Italy, 90129
        • A.O.U. Policlinico 'Paolo Giaccone'
    • PC
      • Piacenza, PC, Italy, 29121
        • Ospedale 'Guglielmo da Saliceto'
    • PD
      • Padova, PD, Italy, 35128
        • Istituto Oncologico Veneto - I.R.C.C.S.
    • PE
      • Penne, PE, Italy, 65017
        • Ospedale Civile 'San Massimo'
    • PG
      • Città di Castello, PG, Italy, 06012
        • Ospedale Civile di Città di Castello - A.S.L. n. 1
      • Perugia, PG, Italy, 06132
        • Ospedale S. Maria Della Misericordia
    • PI
      • Pisa, PI, Italy, 56126
        • A.O.U. Pisana - Ospedale Santa Chiara
      • Pontedera, PI, Italy, 56025
        • Ospedale Felice Lotti - Azienda USL 5 di Pisa
    • PM
      • Roma, PM, Italy, 00186
        • Policlinico Umberto I
    • PR
      • Parma, PR, Italy, 43100
        • Azienda Ospedaliera Universitaria di Parma
    • PS
      • Fano, PS, Italy, 61032
        • Ospedale Santa Croce - A.O. Ospedali Riuniti Marche Nord
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione S. Maugeri IRCCS
    • PZ
      • Potenza, PZ, Italy, 85100
        • Azienda Ospedaliera S. Carlo
    • RA
      • Faenza, RA, Italy, 48018
        • Ospedale per gli Infermi
      • Lugo, RA, Italy, 48022
        • Ospedale Umberto I
    • RC
      • Reggio Calabria, RC, Italy, 89125
        • Azienda Ospedaliera Bianchi - Melacrino - Morelli
    • RE
      • Correggio, RE, Italy, 42015
        • Ospedale San Sebastiano
      • Guastalla, RE, Italy, 42016
        • Ospedale Civile di Guastalla
      • Reggio Emilia, RE, Italy, 42123
        • IRCCS A.O. S.Maria Nuova
    • RM
      • Roma, RM, Italy, 00144
        • Istituto Regina Elena per lo studio e la cura dei tumori
      • Roma, RM, Italy, 00144
        • Ospedale S. Eugenio
      • Roma, RM, Italy, 00149
        • Azienda Ospedaliera San Camillo - Forlanini
      • Roma, RM, Italy, 00186
        • Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina
      • Roma, RM, Italy, 00189
        • A.O. S. Andrea - Università 'La Sapienza' - II Facoltà di Medicina e Chirurgia
    • SS
      • Sassari, SS, Italy, 07100
        • Azienda Ospedaliera n. 1 - Annunziata
    • TO
      • Candiolo, TO, Italy, 10060
        • Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
      • Torino, TO, Italy, 10126
        • Ospedale S. Anna - A.O.U. Città della Salute e della Scienza
      • Torino, TO, Italy, 10126
        • Ospedale S. Anna - Città della salute
    • VA
      • Saronno, VA, Italy, 21047
        • ASST della Valle Olona - Ospedale di Saronno
    • VE
      • Negrar, VE, Italy, 37024
        • Ospedale Sacro Cuore Don Calabria
    • VT
      • Viterbo, VT, Italy, 01100
        • Ospedale Belcolle - AUSL di Viterbo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. Aged ≥ 60

    2. 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:

        • pts with hysterectomy
        • pts who have received hormone replacement therapy (HRT)
        • pts with chemotherapy-induced amenorrhea
    3. 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: ARM A
Adjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm)
Drug: Anastrozole or Letrozole or Exemestane
Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)
Other Names:
  • Clinical Practice
Drug: Anastrozole or Letrozole or Exemestane
Adjuvant chemotherapy + Anastrozole or Letrozole or Exemestane once a day for 5 years (concurrent arm)
Other Names:
  • Experimental arm
Experimental: ARM B
Adjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm)
Drug: Anastrozole or Letrozole or Exemestane
Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)
Other Names:
  • Clinical Practice
Drug: Anastrozole or Letrozole or Exemestane
Adjuvant chemotherapy + Anastrozole or Letrozole or Exemestane once a day for 5 years (concurrent arm)
Other Names:
  • Experimental arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease- free Survival (DFS)
Time Frame: up to 15 years

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
up to 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: time between the date of randomization up to the date of death for any cause, assessed up to 15 years.
time between the date of randomization up to the date of death for any cause, assessed up to 15 years.
Translational Study: genomic analysis
Time Frame: up to 15 years
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.
up to 15 years
Translational Study: epigenetic analysis
Time Frame: up to 15 years
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)
up to 15 years
Translational Study: proteomic analysis
Time Frame: up to 15 years
The different proteomic profiles identified in FFPE sections of hormone receptors positive G2 tumors will be correlated with DFS
up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Clinical Research Technology S.r.l.

Investigators

  • Principal Investigator: Lucia Del Mastro, MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimated)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIM10-CONSENT
  • 2013-001629-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Anastrozole or Letrozole or Exemestane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe