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A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

NCT ID: NCT01940497

Last Updated: 2020-11-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-15

Study Completion Date

2018-03-27

Brief Summary

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This non-randomized, multicenter, open-label study will assess the safety and efficacy of subcutaneously administered trastuzumab in participants with early and locally advanced HER2-positive breast cancer in two sequential cohorts. First 120 participants will be treated with subcutaneous (SC) trastuzumab 600 milligrams (mg) vial (Cohort A) and the subsequent 120 participants will be treated with SC trastuzumab prefilled single use injection device (SID) (Cohort B). Participants from each cohort will receive neoadjuvant or adjuvant chemotherapy consisting of doxorubicin every 3 weeks (q3w) (1 cycle) for 4 cycles followed by paclitaxel weekly or docetaxel every 3 weeks (q3w) in combination with SC trastuzumab (600 mg) q3w for 4 cycles and a further 14 cycles of SC trastuzumab (600 mg) q3w alone. All participants will be followed up for 24 months after the last participant has received the last dose of study treatment, or earlier in case of withdrawal from the study, loss to follow-up or death.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trastuzumab (Vial)

Participants will receive trastuzumab 600 mg SC using a vial q3w (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

Participants will receive doxorubicin in doses according to the locally-approved regimen q3w (1 cycle), for 4 cycles prior to initiation of trastuzumab treatment.

Docetaxel

Intervention Type DRUG

Participants will receive docetaxel in doses according to the locally-approved regimen q3w for 12 weeks, in combination with trastuzumab.

Paclitaxel

Intervention Type DRUG

Participants will receive paclitaxel in doses according to the locally-approved regimen weekly for 12 weeks, in combination with trastuzumab.

Trastuzumab

Intervention Type DRUG

Participants will receive trastuzumab 600 mg SC (vial or SID) q3w for 18 cycles.

Trastuzumab (SID)

Participants will receive trastuzumab 600 mg SC using SID q3w (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

Participants will receive doxorubicin in doses according to the locally-approved regimen q3w (1 cycle), for 4 cycles prior to initiation of trastuzumab treatment.

Docetaxel

Intervention Type DRUG

Participants will receive docetaxel in doses according to the locally-approved regimen q3w for 12 weeks, in combination with trastuzumab.

Paclitaxel

Intervention Type DRUG

Participants will receive paclitaxel in doses according to the locally-approved regimen weekly for 12 weeks, in combination with trastuzumab.

Trastuzumab

Intervention Type DRUG

Participants will receive trastuzumab 600 mg SC (vial or SID) q3w for 18 cycles.

Interventions

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Doxorubicin

Participants will receive doxorubicin in doses according to the locally-approved regimen q3w (1 cycle), for 4 cycles prior to initiation of trastuzumab treatment.

Intervention Type DRUG

Docetaxel

Participants will receive docetaxel in doses according to the locally-approved regimen q3w for 12 weeks, in combination with trastuzumab.

Intervention Type DRUG

Paclitaxel

Participants will receive paclitaxel in doses according to the locally-approved regimen weekly for 12 weeks, in combination with trastuzumab.

Intervention Type DRUG

Trastuzumab

Participants will receive trastuzumab 600 mg SC (vial or SID) q3w for 18 cycles.

Intervention Type DRUG

Other Intervention Names

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Herceptin

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast. Stage of disease: T1-4 (T describes size of tumour from 1 to 4), N0-3 (N describes nearby lymph nodes), M0 (M describes distant metastasis)
* HER2-positive disease immunohistochemistry (IHC) 3+ or in situ hybridization (ISH) positive
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Left ventricular ejection fraction (LVEF) of greater than or equal to (\>=) 55 percent (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC
* Intact skin at site of SC injection on the thigh

Exclusion Criteria

* History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
* Severe dyspnea at rest or requiring supplementary oxygen therapy
* Concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
* Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension
* Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Pregnant or lactating women
* Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
* Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device (for Cohort B), or a history of severe allergic or immunological reactions, for example, difficulty to control asthma
* Inadequate bone marrow, hepatic or renal function
* Hormonal treatment concomitant with chemotherapy (allowed in adjuvant phase with adjuvant trastuzumab SC)
* Pre-existing motor or sensory neuropathy of Grade greater than (\>) 1
* Synchronous bilateral invasive breast cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Asl 4 - Osp. San Salvatore; Oncologia Medica

L’Aquila, Abruzzo, Italy

Site Status

Ospedale San Carlo; Day Hospital Oncologia Medica

Potenza, Basilicate, Italy

Site Status

Campus Universitario S.Venuta; Centro Oncologico T.Campanella

Catanzaro, Calabria, Italy

Site Status

Az. Osp. ; Divisione Oncologia Medica

Reggio Calabria, Calabria, Italy

Site Status

Azienda Ospedaliera S.G. Moscati; Division of Medical Oncology

Avellino, Campania, Italy

Site Status

Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia

Frattamaggiore, Campania, Italy

Site Status

Seconda Università di Napoli;Day Hospital Clinica Oncologia Medica

Napoli, Campania, Italy

Site Status

Ospedale Bellaria; U.O. Oncologia Medica

Bologna, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

Bologna, Emilia-Romagna, Italy

Site Status

Ospedale Ramazzini ; Day Hospital Oncologico

Carpi, Emilia-Romagna, Italy

Site Status

Ospedale Civile; Day Hospital Oncologico

Guastalla, Emilia-Romagna, Italy

Site Status

Arcispedale Santa Maria Nuova; Oncologia

Reggio Emilia, Emilia-Romagna, Italy

Site Status

Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

Aviano, Friuli Venezia Giulia, Italy

Site Status

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

Udine, Friuli Venezia Giulia, Italy

Site Status

Policlinico A. Gemelli-Complesso Integrato Columbus-Radioterapia

Rome, Lazio, Italy

Site Status

Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna

Rome, Lazio, Italy

Site Status

Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia

Rome, Lazio, Italy

Site Status

Villa San Pietro Fatebenefatelli; Divisione Oncologia

Rome, Lazio, Italy

Site Status

Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical

Genoa, Liguria, Italy

Site Status

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

Genoa, Liguria, Italy

Site Status

Ospedale Civile S. Andrea; Day Hospital Oncologia

La Spezia, Liguria, Italy

Site Status

Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

Brescia, Lombardy, Italy

Site Status

Casa Di Cura Poliambulanza; Unita Operativa Di Oncologia Medica

Brescia, Lombardy, Italy

Site Status

Ospedale Valduce;U.O.S. Oncologia Ed Ematologia

Como, Lombardy, Italy

Site Status

ASST DI LECCO; Oncologia Medica

Lecco, Lombardy, Italy

Site Status

Az. Osp. Carlo Poma; Divisione Di Oncologia Medica

Mantova, Lombardy, Italy

Site Status

Irccs Ospedale San Raffaele;Oncologia Medica

Milan, Lombardy, Italy

Site Status

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Site Status

Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

Pavia, Lombardy, Italy

Site Status

Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica

Saronno, Lombardy, Italy

Site Status

ASST DI BERGAMO OVEST; Unità Operativa di Oncologia Medica

Treviglio, Lombardy, Italy

Site Status

Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica

Varese, Lombardy, Italy

Site Status

Azienda Sanitaria Locale Di Asti-P.O. Cardinal Massaia;Oncologia

Asti, Piedmont, Italy

Site Status

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

Candiolo, Piedmont, Italy

Site Status

Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica

Cuneo, Piedmont, Italy

Site Status

Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

Ponderano (BI), Piedmont, Italy

Site Status

Ospedale Mauriziano Umberto I; Divisione Onco-Ematologia

Turin, Piedmont, Italy

Site Status

Centro Catanese Di Oncologia; Oncologia Medica

Catania, Sicily, Italy

Site Status

A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

Ancona, The Marches, Italy

Site Status

Ospedale Di Macerata; Oncologia

Macerata, The Marches, Italy

Site Status

Ospedale San Salvatore Muraglia;Divisone Oncologia

Pesaro, The Marches, Italy

Site Status

Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

Arezzo, Tuscany, Italy

Site Status

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Florence, Tuscany, Italy

Site Status

Ospedale della Misericordia; Hospice Terapia del Dolore

Grosseto, Tuscany, Italy

Site Status

Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

Lido di Camaiore, Tuscany, Italy

Site Status

Ospedale Civile; Unita Operativa Di Oncologia Medica

Livorno, Tuscany, Italy

Site Status

Azienda Usl 7; Dept. Oncologico

Poggibonsi, Tuscany, Italy

Site Status

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

Sant'Andrea Delle Fratte (PG), Umbria, Italy

Site Status

Presidio Ospedaliero - Usl 13; Servizio Di Oncologia

Castelfranco Veneto, Veneto, Italy

Site Status

AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica

Mestre, Veneto, Italy

Site Status

Ospedale Calvi di Noale; U.O. Complessa di Oncologia ed Ematologia Oncologica

Mirano, Veneto, Italy

Site Status

Ospedale Sacro Cuore Don Calabria; U.O. Di Oncologia

Negrar, Veneto, Italy

Site Status

Ospedale Cà Foncello - Divisione di Oncologia Medica

Treviso, Veneto, Italy

Site Status

Ospedale Di Vicenza; Nefrologia, Oncologia Medica

Vicenza, Veneto, Italy

Site Status

Countries

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Italy

References

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Zambetti M, Montemurro F, Morandi P, Zamagni C, Brandes AA, Bisagni G, Cagossi K, Bengala C, Gori S, Iannacone C, Stell A, Gianni L. Safety profile of subcutaneous trastuzumab for the treatment of patients with HER2-positive early or locally advanced breast cancer: primary analysis of the SCHEARLY study. Eur J Cancer. 2018 Dec;105:61-70. doi: 10.1016/j.ejca.2018.09.034. Epub 2018 Nov 3.

Reference Type DERIVED
PMID: 30396014 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2013-001161-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28879

Identifier Type: -

Identifier Source: org_study_id