CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer

NCT ID: NCT02918084

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2028-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM A

Adjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm)

Group Type: SHAM_COMPARATOR

Anastrozole or Letrozole or Exemestane

Intervention Type: DRUG

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

ARM B

Adjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm)

Group Type: EXPERIMENTAL

Anastrozole or Letrozole or Exemestane

Intervention Type: DRUG

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

Interventions

Anastrozole or Letrozole or Exemestane

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

Intervention Type: DRUG

Anastrozole or Letrozole or Exemestane

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

Intervention Type: DRUG

Other Intervention Names

Clinical Practice; Experimental arm

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinical Research Technology S.r.l.

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Lucia Del Mastro,MD

Director of S.S. Innovative Therapies Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucia Del Mastro, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Ospedale Santo SpiritoH

Casale Monferrato, AL, Italy

Ospedale di Rete 'Engles Profili' - A.S.U.R. Area Vasta 2

Fabriano, AN, Italy

A.O. San Giuseppe Moscati

Avellino, AV, Italy

Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico

Bari, BA, Italy

ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII

Bergamo, BG, Italy

Azienda Ospedaliera Treviglio-Caravaggio

Treviglio, BG, Italy

Azienda Ospedaliera G. Rummo

Benevento, BN, Italy

Ospedale Fatebenefratelli 'Sacro Cuore di Gesù'

Benevento, BN, Italy

Presidio Ospedaliero 'Antonio Perrino'

Brindisi, BR, Italy

ASST Spedali Civili - P.O. Spedali Civili

Brescia, BS, Italy

Ospedale Civile di Campobasso - A. Cardarelli

Campobasso, CB, Italy

Ospedale Vietri

Larino, CB, Italy

Ospedale Clinicizzato 'S. Annunziata' - Università degli Studi 'G. d'Annunzio'

Chieti, CH, Italy

Ospedale Civile Renzetti

Lanciano, CH, Italy

Ospedale Civile 'Gaetano Bernabeo'

Ortona, CH, Italy

Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, Italy

ASST Lariana - Ospedale S. Anna

Como, CO, Italy

Humanitas Centro Catanese di Oncologia

Catania, CT, Italy

IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, FC, Italy

Arcispedale S. Anna - A.O.U. di Ferrara

Cona, FE, Italy

IRCCS 'Casa Sollievo della Sofferenza'

San Giovanni Rotondo, FG, Italy

A.O.U. Careggi

Florence, FI, Italy

AUSL di Frosinone - Ospedale Fabrizio Spaziani

Frosinone, FR, Italy

AUSL di Frosinone - Ospedale SS. Trinità

Sora, FR, Italy

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

Genoa, GE, Italy

E.O. Ospedali Galliera

Genova, GE, Italy

Azienda U.S.L. N. 9 - Ospedale Misericordia

Grosseto, GR, Italy

Azienda Sanitaria Regionale Molise - Ospedale F. Veneziale - Zona di Isernia

Isernia, IS, Italy

Ospedale Vito Fazzi

Lecce, LE, Italy

A.S.L. LT - Ospedale Santa Maria Goretti

Latina, LT, Italy

Ospedale Unico Versilia

Lido di Camaiore, LU, Italy

Ospedale San Luca

Lucca, LU, Italy

ASST Monza - Ospedale San Gerardo

Monza, MB, Italy

Ospedale di Macerata

Macerata, MC, Italy

ASST Melegnano e della Martesana - Ospedale Serbelloni

Gorgonzola, MI, Italy

ASST Ovest Milanese - Ospedale Nuovo di Legnano

Legnano, MI, Italy

ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico

Milan, MI, Italy

Istituto Europeo di Oncologia (IRCCS)

Milan, MI, Italy

Azienda Ospedaliera Carlo Poma

Mantova, MN, Italy

A.O.U. Policlinico Modena

Modena, MO, Italy

A.O.U. Policlinico 'Paolo Giaccone'

Palermo, PA, Italy

Ospedale 'Guglielmo da Saliceto'

Piacenza, PC, Italy

Istituto Oncologico Veneto - I.R.C.C.S.

Padua, PD, Italy

Ospedale Civile 'San Massimo'

Penne, PE, Italy

Ospedale Civile di Città di Castello - A.S.L. n. 1

Città di Castello, PG, Italy

Ospedale S. Maria della Misericordia

Perugia, PG, Italy

A.O.U. Pisana - Ospedale Santa Chiara

Pisa, PI, Italy

Ospedale Felice Lotti - Azienda USL 5 di Pisa

Pontedera, PI, Italy

Policlinico Umberto I

Roma, PM, Italy

Azienda Ospedaliera Universitaria di Parma

Parma, PR, Italy

Ospedale Santa Croce - A.O. Ospedali Riuniti Marche Nord

Fano, PS, Italy

Fondazione S. Maugeri IRCCS

Pavia, PV, Italy

Azienda Ospedaliera S. Carlo

Potenza, PZ, Italy

Ospedale per gli Infermi

Faenza, RA, Italy

Ospedale Umberto I

Lugo, RA, Italy

Azienda Ospedaliera Bianchi - Melacrino - Morelli

Reggio Calabria, RC, Italy

Ospedale San Sebastiano

Correggio, RE, Italy

Ospedale Civile di Guastalla

Guastalla, RE, Italy

IRCCS A.O. S.Maria Nuova

Reggio Emilia, RE, Italy

Istituto Regina Elena per lo studio e la cura dei tumori

Roma, RM, Italy

Ospedale S. Eugenio

Roma, RM, Italy

Azienda Ospedaliera San Camillo - Forlanini

Roma, RM, Italy

Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina

Roma, RM, Italy

A.O. S. Andrea - Università 'La Sapienza' - II Facoltà di Medicina e Chirurgia

Roma, RM, Italy

Azienda Ospedaliera n. 1 - Annunziata

Sassari, SS, Italy

Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo

Candiolo, TO, Italy

Ospedale S. Anna - A.O.U. Città della Salute e della Scienza

Torino, TO, Italy

Ospedale S. Anna - Città della salute

Torino, TO, Italy

ASST della Valle Olona - Ospedale di Saronno

Saronno, VA, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, VE, Italy

Ospedale Belcolle - AUSL di Viterbo

Viterbo, VT, Italy

A.O.U. Federico II

Napoli, , Italy

Azienda Ospedaliera 'A. Cardarelli' (AORN)

Napoli, , Italy

Istituto Nazionale dei Tumori - Fondazione G.Pascale

Napoli, , Italy

Countries

Italy

Other Identifiers

2013-001629-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GIM10-CONSENT

Identifier Type: -

Identifier Source: org_study_id