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Breast cancer study tests best order for chemo and hormone pills

NCT ID NCT02918084

Disease control Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compares giving hormone therapy (aromatase inhibitors) at the same time as chemotherapy versus after chemotherapy in 1000 postmenopausal women with early breast cancer. The goal is to see which timing better prevents the cancer from coming back over 15 years. Participants take the hormone pill daily for 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anastrozole, Letrozole, or Exemestane (aromatase inhibitors) given alongside or after chemotherapy
What this could lead to
If it works, this could show the best way to combine chemotherapy and hormone therapy to reduce the chance of breast cancer returning.
What could go wrong
This is a large phase 3 trial, but results are not yet available. The benefit may be small, and side effects from combining treatments could be higher.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jun 2013

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

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

    Roma, RM, 00189, Italy

  • A.O. San Giuseppe Moscati

    Avellino, AV, 83100, Italy

  • A.O.U. Careggi

    Florence, FI, 50134, Italy

  • A.O.U. Federico II

    Naples, 80131, Italy

  • A.O.U. Pisana - Ospedale Santa Chiara

    Pisa, PI, 56126, Italy

  • A.O.U. Policlinico 'Paolo Giaccone'

    Palermo, PA, 90129, Italy

  • A.O.U. Policlinico Modena

    Modena, MO, 41124, Italy

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

    Latina, LT, 04100, Italy

  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico

    Milan, MI, 20121, Italy

  • ASST Lariana - Ospedale S. Anna

    Como, CO, 22100, Italy

  • ASST Melegnano e della Martesana - Ospedale Serbelloni

    Gorgonzola, MI, 20064, Italy

  • ASST Monza - Ospedale San Gerardo

    Monza, MB, 20052, Italy

  • ASST Ovest Milanese - Ospedale Nuovo di Legnano

    Legnano, MI, 20025, Italy

  • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII

    Bergamo, BG, 24127, Italy

  • ASST Spedali Civili - P.O. Spedali Civili

    Brescia, BS, 25123, Italy

  • ASST della Valle Olona - Ospedale di Saronno

    Saronno, VA, 21047, Italy

  • AUSL di Frosinone - Ospedale Fabrizio Spaziani

    Frosinone, FR, 03100, Italy

  • AUSL di Frosinone - Ospedale SS. Trinità

    Sora, FR, 03039, Italy

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

    Cona, FE, 44124, Italy

  • Azienda Ospedaliera 'A. Cardarelli' (AORN)

    Naples, 80131, Italy

  • Azienda Ospedaliera Bianchi - Melacrino - Morelli

    Reggio Calabria, RC, 89125, Italy

  • Azienda Ospedaliera Carlo Poma

    Mantua, MN, 46100, Italy

  • Azienda Ospedaliera G. Rummo

    Benevento, BN, 82100, Italy

  • Azienda Ospedaliera S. Carlo

    Potenza, PZ, 85100, Italy

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, CN, 12100, Italy

  • Azienda Ospedaliera San Camillo - Forlanini

    Roma, RM, 00149, Italy

  • Azienda Ospedaliera Treviglio-Caravaggio

    Treviglio, BG, 24047, Italy

  • Azienda Ospedaliera Universitaria di Parma

    Parma, PR, 43100, Italy

  • Azienda Ospedaliera n. 1 - Annunziata

    Sassari, SS, 07100, Italy

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

    Isernia, IS, 86170, Italy

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

    Grosseto, GR, 58100, Italy

  • E.O. Ospedali Galliera

    Genova, GE, 16128, Italy

  • Fondazione S. Maugeri IRCCS

    Pavia, PV, 27100, Italy

  • Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo

    Candiolo, TO, 10060, Italy

  • Humanitas Centro Catanese di Oncologia

    Catania, CT, 95126, Italy

  • IRCCS 'Casa Sollievo della Sofferenza'

    San Giovanni Rotondo, FG, 71013, Italy

  • IRCCS A.O. S.Maria Nuova

    Reggio Emilia, RE, 42123, Italy

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

    Genoa, GE, 16132, Italy

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

    Meldola, FC, 47014, Italy

  • Istituto Europeo di Oncologia (IRCCS)

    Milan, MI, 20141, Italy

  • Istituto Nazionale dei Tumori - Fondazione G.Pascale

    Naples, 80131, Italy

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

    Padova, PD, 35128, Italy

  • Istituto Regina Elena per lo studio e la cura dei tumori

    Roma, RM, 00144, Italy

  • Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico

    Bari, BA, 70124, Italy

  • Ospedale 'Guglielmo da Saliceto'

    Piacenza, PC, 29121, Italy

  • Ospedale Belcolle - AUSL di Viterbo

    Viterbo, VT, 01100, Italy

  • Ospedale Civile 'Gaetano Bernabeo'

    Ortona, CH, 66026, Italy

  • Ospedale Civile 'San Massimo'

    Penne, PE, 65017, Italy

  • Ospedale Civile Renzetti

    Lanciano, CH, 66034, Italy

  • Ospedale Civile di Campobasso - A. Cardarelli

    Campobasso, CB, 86100, Italy

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

    Città di Castello, PG, 06012, Italy

  • Ospedale Civile di Guastalla

    Guastalla, RE, 42016, Italy

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

    Chieti, CH, 66100, Italy

  • Ospedale Fatebenefratelli 'Sacro Cuore di Gesù'

    Benevento, BN, 82100, Italy

  • Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina

    Roma, RM, 00186, Italy

  • Ospedale Felice Lotti - Azienda USL 5 di Pisa

    Pontedera, PI, 56025, 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

  • Ospedale S. Eugenio

    Roma, RM, 00144, Italy

  • Ospedale S. Maria della Misericordia

    Perugia, PG, 06132, Italy

  • Ospedale Sacro Cuore Don Calabria

    Negrar, VE, 37024, Italy

  • Ospedale San Luca

    Lucca, LU, 55100, Italy

  • Ospedale San Sebastiano

    Correggio, RE, 42015, Italy

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

    Fano, PS, 61032, Italy

  • Ospedale Santo SpiritoH

    Casale Monferrato, AL, 15033, Italy

  • Ospedale Umberto I

    Lugo, RA, 48022, Italy

  • Ospedale Unico Versilia

    Lido di Camaiore, LU, 55041, Italy

  • Ospedale Vietri

    Larino, CB, 80035, Italy

  • Ospedale Vito Fazzi

    Lecce, LE, 73100, Italy

  • Ospedale di Macerata

    Province of Macerata, MC, 62100, Italy

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

    Fabriano, AN, 60044, Italy

  • Ospedale per gli Infermi

    Faenza, RA, 48018, Italy

  • Policlinico Umberto I

    Roma, PM, 00186, Italy

  • Presidio Ospedaliero 'Antonio Perrino'

    Brindisi, BR, 72100, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.