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

Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02918084
Collaborator
Clinical Research Technology S.r.l. (Industry)
1,000
Enrollment
74
Locations
2
Arms
180
Duration (Months)
13.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anastrozole or Letrozole or Exemestane
  • Drug: Anastrozole or Letrozole or Exemestane
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Study Start Date :
Jun 1, 2013
Anticipated Primary Completion Date :
Jun 1, 2028
Anticipated Study Completion Date :
Jun 1, 2028

Arms and Interventions

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

    		•
    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 (concurrent arm)
    Other Names:
  • Experimental arm

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease- free Survival (DFS) [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

    Secondary Outcome Measures

    1. Overall Survival (OS) [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 [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.

    3. Translational Study: epigenetic analysis [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)

    4. Translational Study: proteomic analysis [up to 15 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lucia Del Mastro,MD, Director of S.S. Innovative Therapies Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
    ClinicalTrials.gov Identifier:
    NCT02918084
    Other Study ID Numbers:
    • GIM10-CONSENT
    • 2013-001629-23
    First Posted:
    Sep 28, 2016
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Lucia Del Mastro,MD, Director of S.S. Innovative Therapies Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
    sequential administration chemiotherapy
    early breast cancer
    breast cancer
    aromatase inhibitor
    adjuvant
    post menopausal
    Additional relevant MeSH terms:
    Breast Neoplasms
    Letrozole
    Anastrozole
    Exemestane

    Study Results

    No Results Posted as of May 24, 2022