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Breast CancerPhase 3SCHEARLYNCT01940497

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

A Phase 3 study testing Doxorubicin, Docetaxel and Paclitaxel in people with Breast Cancer, run by Hoffmann-La Roche at 54 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Doxorubicin, Docetaxel and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
54 sitesItaly
Study dates
15 Nov 2013to 27 Mar 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

Italy54 sites

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

    Ancona, The Marches, 60121

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

    Arezzo, Tuscany, 52100

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

    Asti, Piedmont, 14100

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

    Avellino, Campania, 83100

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

    Aviano, Friuli Venezia Giulia, 33081

  • Ospedale Bellaria; U.O. Oncologia Medica

    Bologna, Emilia-Romagna, 40133

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

    Bologna, Emilia-Romagna, 40138

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

    Brescia, Lombardy, 25123

  • Casa Di Cura Poliambulanza; Unita Operativa Di Oncologia Medica

    Brescia, Lombardy, 25124

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

    Candiolo, Piedmont, 10060

  • Ospedale Ramazzini ; Day Hospital Oncologico

    Carpi, Emilia-Romagna, 41012

  • Presidio Ospedaliero - Usl 13; Servizio Di Oncologia

    Castelfranco Veneto, Veneto, 31033

  • Centro Catanese Di Oncologia; Oncologia Medica

    Catania, Sicily, 95126

  • Campus Universitario S.Venuta; Centro Oncologico T.Campanella

    Catanzaro, Calabria, 88100

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

    Como, Lombardy, 22100

  • Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica

    Cuneo, Piedmont, 12100

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

    Florence, Tuscany, 50139

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

    Frattamaggiore, Campania, 80027

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

    Genoa, Liguria, 16132

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

    Genoa, Liguria, 16132

  • Ospedale della Misericordia; Hospice Terapia del Dolore

    Grosseto, Tuscany, 58100

  • Ospedale Civile; Day Hospital Oncologico

    Guastalla, Emilia-Romagna, 42016

  • Asl 4 - Osp. San Salvatore; Oncologia Medica

    L’Aquila, Abruzzo, 67010

  • Ospedale Civile S. Andrea; Day Hospital Oncologia

    La Spezia, Liguria, 19125

  • ASST DI LECCO; Oncologia Medica

    Lecco, Lombardy, 23900

  • Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

    Lido di Camaiore, Tuscany, 55043

  • Ospedale Civile; Unita Operativa Di Oncologia Medica

    Livorno, Tuscany, 57100

  • Az. Osp. Carlo Poma; Divisione Di Oncologia Medica

    Mantua, Lombardy, 46100

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

    Mestre, Veneto, 30174

  • Irccs Ospedale San Raffaele;Oncologia Medica

    Milan, Lombardy, 20132

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

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

    Mirano, Veneto, 30035

  • Seconda Università di Napoli;Day Hospital Clinica Oncologia Medica

    Naples, Campania, 80131

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

    Negrar, Veneto, 37024

  • Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

    Pavia, Lombardy, 27100

  • Ospedale San Salvatore Muraglia;Divisone Oncologia

    Pesaro, The Marches, 61122

  • Azienda Usl 7; Dept. Oncologico

    Poggibonsi, Tuscany, 53036

  • Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

    Ponderano (BI), Piedmont, 13875

  • Ospedale San Carlo; Day Hospital Oncologia Medica

    Potenza, Basilicate, 85100

  • Ospedale Di Macerata; Oncologia

    Province of Macerata, The Marches, 62100

  • Az. Osp. ; Divisione Oncologia Medica

    Reggio Calabria, Calabria, 89100

  • Arcispedale Santa Maria Nuova; Oncologia

    Reggio Emilia, Emilia-Romagna, 42100

  • Policlinico A. Gemelli-Complesso Integrato Columbus-Radioterapia

    Rome, Lazio, 00168

  • Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna

    Rome, Lazio, 00168

  • Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia

    Rome, Lazio, 00186

  • Villa San Pietro Fatebenefatelli; Divisione Oncologia

    Rome, Lazio, 00189

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

    Sant'Andrea Delle Fratte (PG), Umbria, 06132

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

    Saronno, Lombardy, 21047

  • ASST DI BERGAMO OVEST; Unità Operativa di Oncologia Medica

    Treviglio, Lombardy, 24047

  • Ospedale Cà Foncello - Divisione di Oncologia Medica

    Treviso, Veneto, 31100

  • Ospedale Mauriziano Umberto I; Divisione Onco-Ematologia

    Turin, Piedmont, 10128

  • Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

    Udine, Friuli Venezia Giulia, 33100

  • Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica

    Varese, Lombardy, 21100

  • Ospedale Di Vicenza; Nefrologia, Oncologia Medica

    Vicenza, Veneto, 36100

Other trials in Italy

About this study

Official title: National Phase IIIb Prospective Two-Cohort Non-Randomized, Multi-centre, Open Label Study to Assess the Safety of Subcutaneous Trastuzumab and Molecular Biomarkers in Patients With Early and Locally Advanced HER2-Positive Breast Cancer

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.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxorubicinDrug

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

  • DocetaxelDrug

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

  • PaclitaxelDrug

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

  • TrastuzumabDrug

    Also called Herceptin

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

Study groups in NCT01940497
Study groupRoleWhat they receive
Trastuzumab (Vial)ExperimentalParticipants 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).
Receives: Drug: Doxorubicin; Drug: Docetaxel; Drug: Paclitaxel; Drug: Trastuzumab
Trastuzumab (SID)ExperimentalParticipants 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).
Receives: Drug: Doxorubicin; Drug: Docetaxel; Drug: Paclitaxel; Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the AEs occurring from starting on the day of or after first administration of trastuzumab and within 28 days after last dose of trastuzumab. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.

    Measured: Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year)

Secondary outcomes (10)

  1. Actual Dose of Trastuzumab Administered

    Actual dose (mg) administered = (sum over all cycles of actual dose received [mg] divided by number of cycles). Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.

    Measured: Day 1 up last dose of trastuzumab (up to approximately 1 year)

  2. Duration of Treatment With Trastuzumab

    Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.

    Measured: Day 1 up last dose of trastuzumab (up to approximately 1 year)

  3. Percentage of Participants Who Received Concomitant Medications

    Measured: Screening (Day -28 to -1) up to 2.5 years

  4. Percentage of Participants With Pathological Complete Response (pCR) (Neoadjuvant Groups Only) Using Mammography

    In the neoadjuvant setting, the activity of two sequential drug regimens, doxorubicin-containing chemotherapy followed by paclitaxel or docetaxel chemotherapy in combination with trastuzumab, was assessed as the percentage of participants with pCR in breast and nodes using mammography. pCR was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after preoperative treatment. Data for this outcome measure were analyzed and reported only for neoadjuvant groups within each treatment arm.

    Measured: Day 1 up to 24 weeks

  5. Percentage of Participants With Event (Local, Regional or Distant Recurrence, Contralateral Breast Cancer or Death) Using Mammography

    A participant was considered as disease free if the participant was free from local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Percentage of participants with event at the cut off date were reported. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.

    Measured: Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first [up to approximately 4.5 years])

  6. Disease-Free Survival (DFS) Using Mammography

    DFS was defined as the time from the first treatment to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Kaplan-Meier estimates were used for analysis. Participants who were disease-free were censored at the data cut off date. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.

    Measured: Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first [up to approximately 4.5 years])

  7. Percentage of Participants Who Died

    Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.

    Measured: Day 1 up to death due to any cause (up to approximately 4.5 years)

  8. Overall Survival (OS)

    Overall survival was defined as the time from the first treatment to death from any cause. Kaplan-Meier estimates were used for analysis. Participants who did not die were censored on the date they were last known to be alive. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.

    Measured: Day 1 up to death due to any cause (up to approximately 4.5 years)

  9. Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)

    Participants were asked the following 5 questions: (1) "Following the first injection given by the physician/nurse and training on how to use the SID, I felt comfortable injecting the study drug by myself"; (2) "The SID was convenient and easy to use"; (3) "I am confident giving myself an injection in the thigh with the SID"; (4) "Taking all things into account, I find self-administration using the SID satisfactory"; (5) "If given the opportunity, I would choose to continue self-injecting the study drug using the SID at home". Response to each question was recorded as either of the following options: "Unknown", "Strongly Disagree", "Disagree", "Unsure", "Agree", "Strongly Agree". Percentage of participants who provided responses to above questions was reported. Data for this outcome measure were analyzed and reported only for Trastuzumab (SID) arm.

    Measured: After at least 14 cycles (1 cycle = 21 days; maximum up to 1 year)

  10. Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)

    Percentage of HCPs providing responses to various questions related to overall ease of study drug administration was reported in different categories, where categories indicate all possible responses to such questions.

    Measured: After at least 4 participants completed 5 cycles of adjuvant treatment (1 cycle = 21 days; maximum up to 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2013 (estimated)
  2. Study start15 Nov 2013
  3. Primary completion5 Apr 2016
  4. Study completion27 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940497
Sponsor's protocol ID
ML28879
Other IDs
2013-001161-16
Acronym
SCHEARLY
Status last verified
Oct 2020
First submitted
9 Sep 2013
Last updated
3 Nov 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 30396014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Doxorubicin, Docetaxel and Paclitaxel in people with Breast Cancer, run by Hoffmann-La Roche at 54 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01940497, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.

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