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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001161-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab (Vial) | Experimental | 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). |
|
| Trastuzumab (SID) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 up last dose of trastuzumab (up to approximately 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asl 4 - Osp. San Salvatore; Oncologia Medica | L’Aquila | Abruzzo | 67010 | Italy | ||
| Ospedale San Carlo; Day Hospital Oncologia Medica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30396014 | Derived | 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. |
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Out of 263 screened participants, 240 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab (Vial) | Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (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). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 27, 2014 | Mar 27, 2019 |
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| Docetaxel | Drug | Participants will receive docetaxel in doses according to the locally-approved regimen q3w for 12 weeks, in combination with trastuzumab. |
|
| Paclitaxel | Drug | Participants will receive paclitaxel in doses according to the locally-approved regimen weekly for 12 weeks, in combination with trastuzumab. |
|
| Trastuzumab | Drug | Participants will receive trastuzumab 600 mg SC (vial or SID) q3w for 18 cycles. |
|
|
| Duration of Treatment With Trastuzumab | Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm. | Day 1 up last dose of trastuzumab (up to approximately 1 year) |
| Percentage of Participants Who Received Concomitant Medications | Screening (Day -28 to -1) up to 2.5 years |
| 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. | Day 1 up to 24 weeks |
| 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. | 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]) |
| 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. | 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]) |
| Percentage of Participants Who Died | Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm. | Day 1 up to death due to any cause (up to approximately 4.5 years) |
| 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. | Day 1 up to death due to any cause (up to approximately 4.5 years) |
| 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. | After at least 14 cycles (1 cycle = 21 days; maximum up to 1 year) |
| 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. | After at least 4 participants completed 5 cycles of adjuvant treatment (1 cycle = 21 days; maximum up to 1 year) |
| Potenza |
| Basilicate |
| 85100 |
| Italy |
| Campus Universitario S.Venuta; Centro Oncologico T.Campanella | Catanzaro | Calabria | 88100 | Italy |
| Az. Osp. ; Divisione Oncologia Medica | Reggio Calabria | Calabria | 89100 | Italy |
| Azienda Ospedaliera S.G. Moscati; Division of Medical Oncology | Avellino | Campania | 83100 | Italy |
| Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia | Frattamaggiore | Campania | 80027 | Italy |
| Seconda Università di Napoli;Day Hospital Clinica Oncologia Medica | Naples | Campania | 80131 | Italy |
| Ospedale Bellaria; U.O. Oncologia Medica | Bologna | Emilia-Romagna | 40133 | Italy |
| Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna | 40138 | Italy |
| Ospedale Ramazzini ; Day Hospital Oncologico | Carpi | Emilia-Romagna | 41012 | Italy |
| Ospedale Civile; Day Hospital Oncologico | Guastalla | Emilia-Romagna | 42016 | Italy |
| Arcispedale Santa Maria Nuova; Oncologia | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Policlinico A. Gemelli-Complesso Integrato Columbus-Radioterapia | Rome | Lazio | 00168 | Italy |
| Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna | Rome | Lazio | 00168 | Italy |
| Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia | Rome | Lazio | 00186 | Italy |
| Villa San Pietro Fatebenefatelli; Divisione Oncologia | Rome | Lazio | 00189 | Italy |
| Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical | Genoa | Liguria | 16132 | Italy |
| IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A | Genoa | Liguria | 16132 | Italy |
| Ospedale Civile S. Andrea; Day Hospital Oncologia | La Spezia | Liguria | 19125 | Italy |
| Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina | Brescia | Lombardy | 25123 | Italy |
| Casa Di Cura Poliambulanza; Unita Operativa Di Oncologia Medica | Brescia | Lombardy | 25124 | Italy |
| Ospedale Valduce;U.O.S. Oncologia Ed Ematologia | Como | Lombardy | 22100 | Italy |
| ASST DI LECCO; Oncologia Medica | Lecco | Lombardy | 23900 | Italy |
| Az. Osp. Carlo Poma; Divisione Di Oncologia Medica | Mantua | Lombardy | 46100 | Italy |
| Irccs Ospedale San Raffaele;Oncologia Medica | Milan | Lombardy | 20132 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica | Pavia | Lombardy | 27100 | Italy |
| Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica | Saronno | Lombardy | 21047 | Italy |
| ASST DI BERGAMO OVEST; Unità Operativa di Oncologia Medica | Treviglio | Lombardy | 24047 | Italy |
| Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica | Varese | Lombardy | 21100 | Italy |
| Azienda Sanitaria Locale Di Asti-P.O. Cardinal Massaia;Oncologia | Asti | Piedmont | 14100 | Italy |
| Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico | Candiolo | Piedmont | 10060 | Italy |
| Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica | Cuneo | Piedmont | 12100 | Italy |
| Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica | Ponderano (BI) | Piedmont | 13875 | Italy |
| Ospedale Mauriziano Umberto I; Divisione Onco-Ematologia | Turin | Piedmont | 10128 | Italy |
| Centro Catanese Di Oncologia; Oncologia Medica | Catania | Sicily | 95126 | Italy |
| A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica | Ancona | The Marches | 60121 | Italy |
| Ospedale San Salvatore Muraglia;Divisone Oncologia | Pesaro | The Marches | 61122 | Italy |
| Ospedale Di Macerata; Oncologia | Province of Macerata | The Marches | 62100 | Italy |
| Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia | Arezzo | Tuscany | 52100 | Italy |
| Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1 | Florence | Tuscany | 50139 | Italy |
| Ospedale della Misericordia; Hospice Terapia del Dolore | Grosseto | Tuscany | 58100 | Italy |
| Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica | Lido di Camaiore | Tuscany | 55043 | Italy |
| Ospedale Civile; Unita Operativa Di Oncologia Medica | Livorno | Tuscany | 57100 | Italy |
| Azienda Usl 7; Dept. Oncologico | Poggibonsi | Tuscany | 53036 | Italy |
| Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica | Sant'Andrea Delle Fratte (PG) | Umbria | 06132 | Italy |
| Presidio Ospedaliero - Usl 13; Servizio Di Oncologia | Castelfranco Veneto | Veneto | 31033 | Italy |
| AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica | Mestre | Veneto | 30174 | Italy |
| Ospedale Calvi di Noale; U.O. Complessa di Oncologia ed Ematologia Oncologica | Mirano | Veneto | 30035 | Italy |
| Ospedale Sacro Cuore Don Calabria; U.O. Di Oncologia | Negrar | Veneto | 37024 | Italy |
| Ospedale CÃ Foncello - Divisione di Oncologia Medica | Treviso | Veneto | 31100 | Italy |
| Ospedale Di Vicenza; Nefrologia, Oncologia Medica | Vicenza | Veneto | 36100 | Italy |
| Trastuzumab (SID) |
Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (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). |
| Treated |
|
| Treated: Adjuvant |
|
| Treated: Neoadjuvant |
|
| COMPLETED | Completed Treatment Period |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab (Vial) | Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (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). |
| BG001 | Trastuzumab (SID) | Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population | Posted | Number | Percentage of Participants | Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year) |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Population | Posted | Mean | Standard Deviation | mg | Day 1 up last dose of trastuzumab (up to approximately 1 year) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Treatment With Trastuzumab | Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm. | Safety Population | Posted | Mean | Standard Deviation | days | Day 1 up last dose of trastuzumab (up to approximately 1 year) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Received Concomitant Medications | Safety Population | Posted | Number | Percentage of Participants | Screening (Day -28 to -1) up to 2.5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Modified intent-to-treat (m-ITT) population included all enrolled participants satisfying criteria for eligibility. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 up to 24 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | m-ITT population. Here, 'Number of Participants Analyzed' = participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | 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]) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | m-ITT population. Here, 'Number of Participants Analyzed' = participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | 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]) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Died | Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm. | m-ITT population | Posted | Number | Percentage of Participants | Day 1 up to death due to any cause (up to approximately 4.5 years) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | m-ITT population | Posted | Median | 95% Confidence Interval | Months | Day 1 up to death due to any cause (up to approximately 4.5 years) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PSQ population included all enrolled participants from trastuzumab (SID) group who were able to use SID and had completed a minimum of 14 administrations of trastuzumab subcutaneously using SID (at least 10 of which were self-administered). Here, 'Number of Participants Analyzed' = participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | After at least 14 cycles (1 cycle = 21 days; maximum up to 1 year) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | HCPQ population included all investigators and study nurses who completed the questionnaire at each site when at least 4 participants from their site had received at least 5 cycles of adjuvant study treatment (52 and 50, respectively for Vial and SID groups). | Posted | Number | Percentage of HCPs | After at least 4 participants completed 5 cycles of adjuvant treatment (1 cycle = 21 days; maximum up to 1 year) |
|
Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trastuzumab (Vial): Adjuvant | Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). | 5 | 95 | 5 | 95 | 92 | 95 |
| EG001 | Trastuzumab (Vial): Neoadjuvant | Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). | 1 | 20 | 3 | 20 | 20 | 20 |
| EG002 | Trastuzumab (SID) Adjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). | 0 | 92 | 7 | 92 | 79 | 92 |
| EG003 | Trastuzumab (SID) Neoadjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). | 1 | 21 | 2 | 21 | 18 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Pryexia | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
| |
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
| |
| Ovarian epithelial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Hepatitis C virus test positive | Investigations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA Version 20.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2018 | Mar 27, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| OG003 | Trastuzumab (SID): Neoadjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). |
|
|
| OG003 | Trastuzumab (SID): Neoadjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). |
|
|
|
|
|
| OG002 | Trastuzumab (SID): Adjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). |
| OG003 | Trastuzumab (SID): Neoadjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). |
|
|
| OG002 | Trastuzumab (SID): Adjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). |
| OG003 | Trastuzumab (SID): Neoadjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). |
|
|
| OG003 | Trastuzumab (SID): Neoadjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). |
|
|
| OG003 | Trastuzumab (SID): Neoadjuvant | Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). |
|
|
|
|
|
|