CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer
GIM10-CONSENT
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.
2 other identifiers
interventional
1,000
1 country
74
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Jun 2013
Longer than P75 for phase_3 breast-cancer
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 16, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
May 6, 2026
April 1, 2026
15 years
September 16, 2016
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
up to 15 years
Secondary Outcomes (4)
Overall Survival (OS)
time between the date of randomization up to the date of death for any cause, assessed up to 15 years.
Translational Study: genomic analysis
up to 15 years
Translational Study: epigenetic analysis
up to 15 years
Translational Study: proteomic analysis
up to 15 years
Study Arms (2)
ARM A
SHAM COMPARATORAdjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm)
ARM B
EXPERIMENTALAdjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm)
Interventions
Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)
Eligibility Criteria
You may qualify if:
- 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:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Ospedale Santo SpiritoH
Casale Monferrato, AL, 15033, Italy
Ospedale di Rete 'Engles Profili' - A.S.U.R. Area Vasta 2
Fabriano, AN, 60044, Italy
A.O. San Giuseppe Moscati
Avellino, AV, 83100, Italy
Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico
Bari, BA, 70124, Italy
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo, BG, 24127, Italy
Azienda Ospedaliera Treviglio-Caravaggio
Treviglio, BG, 24047, Italy
Azienda Ospedaliera G. Rummo
Benevento, BN, 82100, Italy
Ospedale Fatebenefratelli 'Sacro Cuore di Gesù'
Benevento, BN, 82100, Italy
Presidio Ospedaliero 'Antonio Perrino'
Brindisi, BR, 72100, Italy
ASST Spedali Civili - P.O. Spedali Civili
Brescia, BS, 25123, Italy
Ospedale Civile di Campobasso - A. Cardarelli
Campobasso, CB, 86100, Italy
Ospedale Vietri
Larino, CB, 80035, Italy
Ospedale Clinicizzato 'S. Annunziata' - Università degli Studi 'G. d'Annunzio'
Chieti, CH, 66100, Italy
Ospedale Civile Renzetti
Lanciano, CH, 66034, Italy
Ospedale Civile 'Gaetano Bernabeo'
Ortona, CH, 66026, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, 12100, Italy
ASST Lariana - Ospedale S. Anna
Como, CO, 22100, Italy
Humanitas Centro Catanese di Oncologia
Catania, CT, 95126, Italy
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, FC, 47014, Italy
Arcispedale S. Anna - A.O.U. di Ferrara
Cona, FE, 44124, Italy
IRCCS 'Casa Sollievo della Sofferenza'
San Giovanni Rotondo, FG, 71013, Italy
A.O.U. Careggi
Florence, FI, 50134, Italy
AUSL di Frosinone - Ospedale Fabrizio Spaziani
Frosinone, FR, 03100, Italy
AUSL di Frosinone - Ospedale SS. Trinità
Sora, FR, 03039, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Genoa, GE, 16132, Italy
E.O. Ospedali Galliera
Genova, GE, 16128, Italy
Azienda U.S.L. N. 9 - Ospedale Misericordia
Grosseto, GR, 58100, Italy
Azienda Sanitaria Regionale Molise - Ospedale F. Veneziale - Zona di Isernia
Isernia, IS, 86170, Italy
Ospedale Vito Fazzi
Lecce, LE, 73100, Italy
A.S.L. LT - Ospedale Santa Maria Goretti
Latina, LT, 04100, Italy
Ospedale Unico Versilia
Lido di Camaiore, LU, 55041, Italy
Ospedale San Luca
Lucca, LU, 55100, Italy
ASST Monza - Ospedale San Gerardo
Monza, MB, 20052, Italy
Ospedale di Macerata
Macerata, MC, 62100, Italy
ASST Melegnano e della Martesana - Ospedale Serbelloni
Gorgonzola, MI, 20064, Italy
ASST Ovest Milanese - Ospedale Nuovo di Legnano
Legnano, MI, 20025, Italy
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico
Milan, MI, 20121, Italy
Istituto Europeo di Oncologia (IRCCS)
Milan, MI, 20141, Italy
Azienda Ospedaliera Carlo Poma
Mantua, MN, 46100, Italy
A.O.U. Policlinico Modena
Modena, MO, 41124, Italy
A.O.U. Policlinico 'Paolo Giaccone'
Palermo, PA, 90129, Italy
Ospedale 'Guglielmo da Saliceto'
Piacenza, PC, 29121, Italy
Istituto Oncologico Veneto - I.R.C.C.S.
Padova, PD, 35128, Italy
Ospedale Civile 'San Massimo'
Penne, PE, 65017, Italy
Ospedale Civile di Città di Castello - A.S.L. n. 1
Città di Castello, PG, 06012, Italy
Ospedale S. Maria della Misericordia
Perugia, PG, 06132, Italy
A.O.U. Pisana - Ospedale Santa Chiara
Pisa, PI, 56126, Italy
Ospedale Felice Lotti - Azienda USL 5 di Pisa
Pontedera, PI, 56025, Italy
Policlinico Umberto I
Roma, PM, 00186, Italy
Azienda Ospedaliera Universitaria di Parma
Parma, PR, 43100, Italy
Ospedale Santa Croce - A.O. Ospedali Riuniti Marche Nord
Fano, PS, 61032, Italy
Fondazione S. Maugeri IRCCS
Pavia, PV, 27100, Italy
Azienda Ospedaliera S. Carlo
Potenza, PZ, 85100, Italy
Ospedale per gli Infermi
Faenza, RA, 48018, Italy
Ospedale Umberto I
Lugo, RA, 48022, Italy
Azienda Ospedaliera Bianchi - Melacrino - Morelli
Reggio Calabria, RC, 89125, Italy
Ospedale San Sebastiano
Correggio, RE, 42015, Italy
Ospedale Civile di Guastalla
Guastalla, RE, 42016, Italy
IRCCS A.O. S.Maria Nuova
Reggio Emilia, RE, 42123, Italy
Istituto Regina Elena per lo studio e la cura dei tumori
Roma, RM, 00144, Italy
Ospedale S. Eugenio
Roma, RM, 00144, Italy
Azienda Ospedaliera San Camillo - Forlanini
Roma, RM, 00149, Italy
Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina
Roma, RM, 00186, Italy
A.O. S. Andrea - Università 'La Sapienza' - II Facoltà di Medicina e Chirurgia
Roma, RM, 00189, Italy
Azienda Ospedaliera n. 1 - Annunziata
Sassari, SS, 07100, Italy
Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
Candiolo, TO, 10060, Italy
Ospedale S. Anna - A.O.U. Città della Salute e della Scienza
Torino, TO, 10126, Italy
Ospedale S. Anna - Città della salute
Torino, TO, 10126, Italy
ASST della Valle Olona - Ospedale di Saronno
Saronno, VA, 21047, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, VE, 37024, Italy
Ospedale Belcolle - AUSL di Viterbo
Viterbo, VT, 01100, Italy
A.O.U. Federico II
Naples, 80131, Italy
Azienda Ospedaliera 'A. Cardarelli' (AORN)
Naples, 80131, Italy
Istituto Nazionale dei Tumori - Fondazione G.Pascale
Naples, 80131, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucia Del Mastro, MD
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of S.S. Innovative Therapies Unit
Study Record Dates
First Submitted
September 16, 2016
First Posted
September 28, 2016
Study Start
June 1, 2013
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share