Clinical trial NCT02918084: CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: sequential administration chemiotherapy
early breast cancer
breast cancer
aromatase inhibitor
adjuvant
post menopausal
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
Collaborators: name: Clinical Research Technology S.r.l.
First posted: 2016-09-28
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease- free Survival (DFS)
timeFrame: up to 15 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: time between the date of randomization up to the date of death for any cause, assessed up to 15 years.
measure: Translational Study: genomic analysis
timeFrame: up to 15 years
measure: Translational Study: epigenetic analysis
timeFrame: up to 15 years
measure: Translational Study: proteomic analysis
timeFrame: up to 15 years
Other outcomes:
Locations:
city: Casale Monferrato
country: Italy
facility: Ospedale Santo SpiritoH
state: AL
city: Fabriano
country: Italy
facility: Ospedale di Rete 'Engles Profili' - A.S.U.R. Area Vasta 2
state: AN
city: Avellino
country: Italy
facility: A.O. San Giuseppe Moscati
state: AV
city: Bari
country: Italy
facility: Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico
state: BA
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
state: BG
city: Treviglio
country: Italy
facility: Azienda Ospedaliera Treviglio-Caravaggio
state: BG
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
state: BN
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli 'Sacro Cuore di Gesù'
state: BN
city: Brindisi
country: Italy
facility: Presidio Ospedaliero 'Antonio Perrino'
state: BR
city: Brescia
country: Italy
facility: ASST Spedali Civili - P.O. Spedali Civili
state: BS
city: Campobasso
country: Italy
facility: Ospedale Civile di Campobasso - A. Cardarelli
state: CB
city: Larino
country: Italy
facility: Ospedale Vietri
state: CB
city: Chieti
country: Italy
facility: Ospedale Clinicizzato 'S. Annunziata' - Università degli Studi 'G. d'Annunzio'
state: CH
city: Lanciano
country: Italy
facility: Ospedale Civile Renzetti
state: CH
city: Ortona
country: Italy
facility: Ospedale Civile 'Gaetano Bernabeo'
state: CH
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle
state: CN
city: Como
country: Italy
facility: ASST Lariana - Ospedale S. Anna
state: CO
city: Catania
country: Italy
facility: Humanitas Centro Catanese di Oncologia
state: CT
city: Meldola
country: Italy
facility: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
state: FC
city: Cona
country: Italy
facility: Arcispedale S. Anna - A.O.U. di Ferrara
state: FE
city: San Giovanni Rotondo
country: Italy
facility: IRCCS 'Casa Sollievo della Sofferenza'
state: FG
city: Firenze
country: Italy
facility: A.O.U. Careggi
state: FI
city: Frosinone
country: Italy
facility: AUSL di Frosinone - Ospedale Fabrizio Spaziani
state: FR
city: Sora
country: Italy
facility: AUSL di Frosinone - Ospedale SS. Trinità
state: FR
city: Genoa
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
state: GE
city: Genova
country: Italy
facility: E.O. Ospedali Galliera
state: GE
city: Grosseto
country: Italy
facility: Azienda U.S.L. N. 9 - Ospedale Misericordia
state: GR
city: Isernia
country: Italy
facility: Azienda Sanitaria Regionale Molise - Ospedale F. Veneziale - Zona di Isernia
state: IS
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
state: LE
city: Latina
country: Italy
facility: A.S.L. LT - Ospedale Santa Maria Goretti
state: LT
city: Lido di Camaiore
country: Italy
facility: Ospedale Unico Versilia
state: LU
city: Lucca
country: Italy
facility: Ospedale San Luca
state: LU
city: Monza
country: Italy
facility: ASST Monza - Ospedale San Gerardo
state: MB
city: Macerata
country: Italy
facility: Ospedale di Macerata
state: MC
city: Gorgonzola
country: Italy
facility: ASST Melegnano e della Martesana - Ospedale Serbelloni
state: MI
city: Legnano
country: Italy
facility: ASST Ovest Milanese - Ospedale Nuovo di Legnano
state: MI
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico
state: MI
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia (IRCCS)
state: MI
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma
state: MN
city: Modena
country: Italy
facility: A.O.U. Policlinico Modena
state: MO
city: Palermo
country: Italy
facility: A.O.U. Policlinico 'Paolo Giaccone'
state: PA
city: Piacenza
country: Italy
facility: Ospedale 'Guglielmo da Saliceto'
state: PC
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - I.R.C.C.S.
state: PD
city: Penne
country: Italy
facility: Ospedale Civile 'San Massimo'
state: PE
city: Città di Castello
country: Italy
facility: Ospedale Civile di Città di Castello - A.S.L. n. 1
state: PG
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia
state: PG
city: Pisa
country: Italy
facility: A.O.U. Pisana - Ospedale Santa Chiara
state: PI
city: Pontedera
country: Italy
facility: Ospedale Felice Lotti - Azienda USL 5 di Pisa
state: PI
city: Roma
country: Italy
facility: Policlinico Umberto I
state: PM
city: Parma
country: Italy
facility: Azienda Ospedaliera Universitaria di Parma
state: PR
city: Fano
country: Italy
facility: Ospedale Santa Croce - A.O. Ospedali Riuniti Marche Nord
state: PS
city: Pavia
country: Italy
facility: Fondazione S. Maugeri IRCCS
state: PV
city: Potenza
country: Italy
facility: Azienda Ospedaliera S. Carlo
state: PZ
city: Faenza
country: Italy
facility: Ospedale per gli Infermi
state: RA
city: Lugo
country: Italy
facility: Ospedale Umberto I
state: RA
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi - Melacrino - Morelli
state: RC
city: Correggio
country: Italy
facility: Ospedale San Sebastiano
state: RE
city: Guastalla
country: Italy
facility: Ospedale Civile di Guastalla
state: RE
city: Reggio Emilia
country: Italy
facility: IRCCS A.O. S.Maria Nuova
state: RE
city: Roma
country: Italy
facility: Istituto Regina Elena per lo studio e la cura dei tumori
state: RM
city: Roma
country: Italy
facility: Ospedale S. Eugenio
state: RM
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo - Forlanini
state: RM
city: Roma
country: Italy
facility: Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina
state: RM
city: Roma
country: Italy
facility: A.O. S. Andrea - Università 'La Sapienza' - II Facoltà di Medicina e Chirurgia
state: RM
city: Sassari
country: Italy
facility: Azienda Ospedaliera n. 1 - Annunziata
state: SS
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
state: TO
city: Torino
country: Italy
facility: Ospedale S. Anna - A.O.U. Città della Salute e della Scienza
state: TO
city: Torino
country: Italy
facility: Ospedale S. Anna - Città della salute
state: TO
city: Saronno
country: Italy
facility: ASST della Valle Olona - Ospedale di Saronno
state: VA
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
state: VE
city: Viterbo
country: Italy
facility: Ospedale Belcolle - AUSL di Viterbo
state: VT
city: Napoli
country: Italy
facility: A.O.U. Federico II
city: Napoli
country: Italy
facility: Azienda Ospedaliera 'A. Cardarelli' (AORN)
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori - Fondazione G.Pascale
Study officials:
affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: Lucia Del Mastro, MD
role: PRINCIPAL_INVESTIGATOR
References: