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Clinical Trials in Italy / NCT02918084
Active, not recruiting Phase 3

CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer

NCT02918084 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Phase
Phase 3
Started
2013-06
Last updated
2026-05-06

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Anastrozole or Letrozole or ExemestaneAll Anastrozole trials (45) →All Letrozole trials (109) →All Exemestane trials (41) →Anastrozole or Letrozole or ExemestaneAll Anastrozole trials (45) →All Letrozole trials (109) →All Exemestane trials (41) →

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

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
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 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 outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
Ospedale Santo SpiritoH Casale Monferrato AL
Ospedale di Rete 'Engles Profili' - A.S.U.R. Area Vasta 2 Fabriano AN
A.O. San Giuseppe Moscati Avellino AV
Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico Bari BA
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII Bergamo BG
Azienda Ospedaliera Treviglio-Caravaggio Treviglio BG
Azienda Ospedaliera G. Rummo Benevento BN
Ospedale Fatebenefratelli 'Sacro Cuore di Gesù' Benevento BN
Presidio Ospedaliero 'Antonio Perrino' Brindisi BR
ASST Spedali Civili - P.O. Spedali Civili Brescia BS
Ospedale Civile di Campobasso - A. Cardarelli Campobasso CB
Ospedale Vietri Larino CB
Ospedale Clinicizzato 'S. Annunziata' - Università degli Studi 'G. d'Annunzio' Chieti CH
Ospedale Civile Renzetti Lanciano CH
Ospedale Civile 'Gaetano Bernabeo' Ortona CH
Azienda Ospedaliera S. Croce e Carle Cuneo CN
ASST Lariana - Ospedale S. Anna Como CO
Humanitas Centro Catanese di Oncologia Catania CT
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) Meldola FC
Arcispedale S. Anna - A.O.U. di Ferrara Cona FE
IRCCS 'Casa Sollievo della Sofferenza' San Giovanni Rotondo FG
A.O.U. Careggi Florence FI
AUSL di Frosinone - Ospedale Fabrizio Spaziani Frosinone FR
AUSL di Frosinone - Ospedale SS. Trinità Sora FR
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy Genoa GE
E.O. Ospedali Galliera Genova GE
Azienda U.S.L. N. 9 - Ospedale Misericordia Grosseto GR
Azienda Sanitaria Regionale Molise - Ospedale F. Veneziale - Zona di Isernia Isernia IS
Ospedale Vito Fazzi Lecce LE
A.S.L. LT - Ospedale Santa Maria Goretti Latina LT
Ospedale Unico Versilia Lido di Camaiore LU
Ospedale San Luca Lucca LU
ASST Monza - Ospedale San Gerardo Monza MB
Ospedale di Macerata Province of Macerata MC
ASST Melegnano e della Martesana - Ospedale Serbelloni Gorgonzola MI
ASST Ovest Milanese - Ospedale Nuovo di Legnano Legnano MI
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico Milan MI
Istituto Europeo di Oncologia (IRCCS) Milan MI
Azienda Ospedaliera Carlo Poma Mantua MN
A.O.U. Policlinico Modena Modena MO

+ 34 more sites — see the full list on the official registry below.

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02918084 on ClinicalTrials.gov ↗ ← All trials in Italy