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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003308-18 | EudraCT Number |
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This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (IV) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion | Experimental | Pertuzumab will be administered as IV infusion on Day 1 of the first treatment cycle (1 cycle = 21 days) as a loading dose of 840 milligrams (mg), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab will be administered as IV infusion on Day 2 of the first treatment cycle as a loading dose of 8 mg per kilogram (mg/kg), followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (will be administered after trastuzumab) on Day 2 and Day 9 of the first treatment cycle at a dose of 25 mg per meter-squared (mg/m^2) followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab will be administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
| Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion | Experimental | Pertuzumab will be administered as IV infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab will be administered as IV infusion on Day 2 of the first treatment cycle as a loading dose of 8 mg/kg, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion on Day 2 and Day 9 of the first treatment cycle at a dose of 25 mg/m^2 followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs is well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg will be administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertuzumab | Drug | Loading dose of 840 mg on Day 1 of first 21-day cycle, followed by 420 mg on Day 1 of each subsequent cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach. | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response as Assessed by Investigator According to RECIST v 1.1 | For participants with a BOR of CR or PR, time to response = (Date of first confirmed CR/PR - Date of first study treatment) + 1. For participants without a CR or PR, time to response = (Date of adequate last tumor assessment - Date of first study treatment) + 1. For participant with no tumor assessment (or if all assessments were progressive disease [PD]) the censoring day was set to date of first study treatment +1. CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation. |
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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 |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85724 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27955684 | Derived | Perez EA, Lopez-Vega JM, Petit T, Zamagni C, Easton V, Kamber J, Restuccia E, Andersson M. Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results. Breast Cancer Res. 2016 Dec 13;18(1):126. doi: 10.1186/s13058-016-0773-6. |
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Due to non-randomized nature of the study (single infusion cohort started enrollment only after separate infusion cohort recruitment was completed) and different baseline characteristics of participants, the comparison between the 2 cohorts was not performed. Hence, the efficacy and safety results for the 2 cohorts should be considered separately.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion | Pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg per kilogram (mg/kg) on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg per meter-squared (mg/m^2) on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Trastuzumab | Drug | Loading dose of 8 mg/kg on Day 1 of first 21-day cycle, followed by 6 mg/kg on Day 1 or 2 of each subsequent cycle. |
|
|
| Vinorelbine | Drug | A dose of 25 mg/m^2 followed by 30-35 mg/m^2 on Days 2 and 9 of the first 21-day cycle and on Days 1 and 8 (or Days 2 and 9) of each subsequent cycle. |
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| Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
| Duration of Response (DOR) as Assessed by Investigator According to RECIST v 1.1 | DOR, in participants with a BOR of CR or PR, was defined as the period from the date of initial PR or CR until the date of PD or death from any cause. Participants with no documented PD or death after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively (regardless of the response at intermediate assessments). CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation. | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
| Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 or Death From Any Cause | PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause was reported. | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
| Progression-free Survival (PFS) as Assessed by Investigator According to RECIST v 1.1 | PFS was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PFS events were censored at the time of the last evaluable tumor assessment. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or died due to any cause were considered as having an event. The median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation. | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
| Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 | PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 was reported. | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
| Time to Progression (TTP) as Assessed by Investigator According to RECIST v 1.1 | TTP was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1. Participants who did not have a radio-graphically documented PD and had died due to reason other than PD were censored on the last available tumor assessment prior to the death date. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 were considered as having an event. The median TTP was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation. | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
| Percentage of Participants Who Died From Any Cause | Percentage of participants who died due to any cause was reported. | Baseline until death (up to approximately 3.5 years) |
| Overall Survival (OS) | OS was defined as the time from first intake of any study medication to the date of death, regardless of the cause of death. Participants who were known to be alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study treatment, and participants with no post-baseline information were censored at the date of first study treatment plus 1 day. Participants who died due to any cause were considered as having an event. The median OS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation. | Baseline until death (up to approximately 3.5 years) |
| Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Visual Analogue Scale (VAS) Score | EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. | Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days) |
| Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score | FACT-B questionnaire is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. | Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days) |
| Stanford |
| California |
| 94305-5151 |
| United States |
| Denver | Colorado | 80220 | United States |
| Hollywood | Florida | 33021 | United States |
| Miami | Florida | 33136 | United States |
| Plantation | Florida | 33324 | United States |
| Marietta | Georgia | 30060 | United States |
| Boston | Massachusetts | 02215 | United States |
| Morristown | New Jersey | 07960 | United States |
| Durham | North Carolina | 27710 | United States |
| Columbus | Ohio | 43210 | United States |
| Houston | Texas | 77090 | United States |
| San Antonio | Texas | 78229 | United States |
| Ogden | Utah | 84403 | United States |
| Fredericksburg | Virginia | 22408 | United States |
| Seattle | Washington | 98101 | United States |
| Seattle | Washington | 98195 | United States |
| Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Barretos | São Paulo | 14784-400 | Brazil |
| São Paulo | São Paulo | 01308-050 | Brazil |
| São Paulo | São Paulo | 01317-000 | Brazil |
| São Paulo | São Paulo | 04039-901 | Brazil |
| Herlev | 2730 | Denmark |
| Herning | 7400 | Denmark |
| København Ø | 2100 | Denmark |
| Odense | 5000 | Denmark |
| Avignon | 84082 | France |
| Bobigny | 93009 | France |
| Caen | 14076 | France |
| La Tronche | 38700 | France |
| Mont-de-Marsan | 40024 | France |
| Paris | 75651 | France |
| Paris | 75908 | France |
| Périgueux | 24000 | France |
| Pierre-Bénite | 69495 | France |
| Plérin | 22190 | France |
| Rouen | 76038 | France |
| Strasbourg | 67065 | France |
| Tours | 37044 | France |
| Villejuif | 94805 | France |
| Cologne | 50677 | Germany |
| Dortmund | 44263 | Germany |
| Dresden | 01307 | Germany |
| Frankfurt am Main | 60389 | Germany |
| Freiburg im Breisgau | 79110 | Germany |
| Georgsmarienhütte | 49124 | Germany |
| Goslar | 38642 | Germany |
| Gütersloh | 33332 | Germany |
| Hamburg | 20357 | Germany |
| Heidelberg | 69115 | Germany |
| Kaiserslautern | 67655 | Germany |
| Kassel | 34119 | Germany |
| Lebach | 66822 | Germany |
| Leer | 26789 | Germany |
| Moers | 47441 | Germany |
| München | 80335 | Germany |
| München | 80639 | Germany |
| Neumarkt | 92318 | Germany |
| Ravensburg | 88212 | Germany |
| Würselen | 52146 | Germany |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Rome | Lazio | 00189 | Italy |
| Genoa | Liguria | 16132 | Italy |
| Cremona | Lombardy | 26100 | Italy |
| Monza | Lombardy | 20900 | Italy |
| Lido di Camaiore | Tuscany | 55043 | Italy |
| Pisa | Tuscany | 56100 | Italy |
| Terni | Umbria | 05100 | Italy |
| Negrar | Veneto | 37024 | Italy |
| Badajoz | Badajoz | 06080 | Spain |
| Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Terrassa | Barcelona | 08227 | Spain |
| Santander | Cantabria | 39008 | Spain |
| Barbastro | Huesca | 22300 | Spain |
| Madrid | Madrid | 28223 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Valencia | Valencia | 46014 | Spain |
| FG001 | Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all participants enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
| BG001 | Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach. | ITT population. Only participants with measurable disease at baseline were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
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| Secondary | Time to Response as Assessed by Investigator According to RECIST v 1.1 | For participants with a BOR of CR or PR, time to response = (Date of first confirmed CR/PR - Date of first study treatment) + 1. For participants without a CR or PR, time to response = (Date of adequate last tumor assessment - Date of first study treatment) + 1. For participant with no tumor assessment (or if all assessments were progressive disease [PD]) the censoring day was set to date of first study treatment +1. CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation. | ITT population. Only participants with measurable disease at baseline were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
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| Secondary | Duration of Response (DOR) as Assessed by Investigator According to RECIST v 1.1 | DOR, in participants with a BOR of CR or PR, was defined as the period from the date of initial PR or CR until the date of PD or death from any cause. Participants with no documented PD or death after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively (regardless of the response at intermediate assessments). CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation. | ITT population. Only participants with a BOR of CR or PR and with measurable disease at baseline were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
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| Secondary | Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 or Death From Any Cause | PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause was reported. | ITT population | Posted | Number | percentage of participants | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
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| Secondary | Progression-free Survival (PFS) as Assessed by Investigator According to RECIST v 1.1 | PFS was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PFS events were censored at the time of the last evaluable tumor assessment. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or died due to any cause were considered as having an event. The median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
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| Secondary | Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 | PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 was reported. | ITT population | Posted | Number | percentage of participants | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
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| Secondary | Time to Progression (TTP) as Assessed by Investigator According to RECIST v 1.1 | TTP was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1. Participants who did not have a radio-graphically documented PD and had died due to reason other than PD were censored on the last available tumor assessment prior to the death date. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 were considered as having an event. The median TTP was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years) |
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| Secondary | Percentage of Participants Who Died From Any Cause | Percentage of participants who died due to any cause was reported. | ITT population | Posted | Number | percentage of participants | Baseline until death (up to approximately 3.5 years) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from first intake of any study medication to the date of death, regardless of the cause of death. Participants who were known to be alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study treatment, and participants with no post-baseline information were censored at the date of first study treatment plus 1 day. Participants who died due to any cause were considered as having an event. The median OS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline until death (up to approximately 3.5 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Visual Analogue Scale (VAS) Score | EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. | ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score | FACT-B questionnaire is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. | ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days) |
|
Day 1 until 28 days after last study treatment (up to approximately 3.5 years)
Treatment-emergent adverse events (TEAEs) are adverse events occurring between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Safety Population included all participants who received at least one dose of any study treatment in any of the 2 cohorts.
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 | Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). | 32 | 106 | 103 | 106 | ||
| EG001 | Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). | 44 | 107 | 106 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sensorimotor disorder | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 18.1 | Non-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 |
| 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 |
|---|---|
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| 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 |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Male |
|
| OG001 | Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
|
| OG001 | Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
|
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
|
| OG001 | Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
|
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
|
| OG001 | Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
|
|
|
| Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion |
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
|
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
|
| OG001 | Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion | Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). |
|
|