| Primary | Percentage of Participants With Adverse Events (AEs) and Serious AEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs and SAEs was reported. AEs included both SAEs and non-SAEs. The 95% confidence interval (CI) was computed using Clopper-Pearson method. | Analysis was performed on the Safety population, which included all enrolled participants who received at least one dose of pertuzumab IV or trastuzumab SC. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to 28 days after last study drug administration (up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
| | | Title | Denominators | Categories |
|---|
| AEs | | | Title | Measurements |
|---|
| - OG000100.0(92.9 to 100.0)
|
| | SAEs | | |
| |
| Secondary | Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | BOR was defined as a confirmed CR or PR. All measurable lesions up to a maximum of 2 lesions per organ and 5 in total were identified as target lesions (TLs) and recorded at baseline. A sum of the diameters (longest for non-nodal lesions, short axis [SA] for nodal lesions) for all TLs was calculated as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs and were recorded at baseline. CR was defined as the disappearance of all TLs and SA reduction to less than (<) 10 millimeter (mm) for nodal TLs/ non-TLs. PR was defined as greater than or equal to (>/=) 30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. The 95% CI was computed using Clopper-Pearson method. | Analysis was performed on ITT population. Only participants with measurable disease at baseline were included in the analysis. Participants without a post-baseline tumor assessment were considered non-responders. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
|
| Secondary | Percentage of Participants With PD (Assessed According to RECIST Version 1.1) or Death Due to Any Cause | For TLs, PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD, taking as reference the smallest SD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. | Analysis was performed on the ITT population. | Posted | | Number | | percentage of participants | | Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
| |
| Secondary | Progression-free Survival (PFS) Assessed According to RECIST Version 1.1 | PFS was defined as the time from start of treatment until first documented PD or death from any cause, whichever occurred first. Participants without PD, death, or who were lost to follow-up at the time of analysis were censored at the date of the last tumor assessment when non-progression was documented or at the last date of follow-up, whichever was last. Participants without tumor assessment data after the baseline were censored at baseline unless death occurred before first scheduled tumor assessment. 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, and/or unequivocal progression of existing non-TLs, or appearance of 1 or more new lesions. Median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method. | Analysis was performed on the ITT population. | Posted | | Median | 95% Confidence Interval | months | | Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
|
| Secondary | Percentage of Participants Who Died Due to Any Cause | Percentage of participants who died due to any cause during the study was reported. | Analysis was performed on the ITT population. | Posted | | Number | | percentage of participants | | Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
| |
| Secondary | Overall Survival (OS) | The OS was defined as the time from the start of treatment until death from any cause. Participants alive at the time of analysis and participants who were lost to follow-up were censored at their last clinical assessment date. Median OS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method. | Analysis was performed on the ITT population. | Posted | | Median | 95% Confidence Interval | months | | Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
| |
| Secondary | Event-free Survival (EFS) Assessed According to RECIST Version 1.1 | EFS was defined as the time from the start of treatment until the first documented initiation of non-protocol-specified treatment for metastatic breast cancer, PD, or death from any cause, whichever occurred first. Participants without treatment change, PD, death, or who were lost to follow-up at the time of analysis were censored at the date of the last tumor assessment when non-progression was documented or at the last date of follow-up, whichever was last. Participants without tumor assessment after baseline were censored at baseline unless death occurred before first scheduled tumor assessment. 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, and/or unequivocal progression of existing non-TLs, or appearance of 1 or more new lesions. Median EFS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method. | Analysis was performed on the ITT population. | Posted | | Median | 95% Confidence Interval | months | | Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
|
| Secondary | Percentage of Participants Who Died During Receiving Second-Line of Treatment | Percentage of participants who died from any cause during second-line of treatment was reported. | Analysis was performed on the ITT population participants who started second-line of treatment. | Posted | | Number | | percentage of participants | | From start of second-line of treatment (any time from baseline up to 35 months) up to death due to any cause or study end (up to approximately 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
| |
| Secondary | OS During Second-Line of Treatment | The OS during second-line therapy was defined as the time from the start of second-line therapy (failure of first-line therapy) until death from any cause. Participants alive at the time of analysis and participants who were lost to follow-up were censored at their last clinical assessment date. Median OS during second-line therapy was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method. | Analysis was performed on the ITT population participants who started second-line of treatment. | Posted | | Median | 95% Confidence Interval | months | | From start of second-line of treatment (any time from baseline up to 35 months) up to death due to any cause or study end (up to approximately 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
|
| Secondary | Number of Participants Receiving Second-Line Treatment by Treatment Type | Second-line anti-cancer treatment was initiated after disease progression on first-line therapy. Number of participants who started second-line of treatment by treatment type was reported. Participants who received combination treatment were counted for each treatment type. | Analysis was performed on the ITT population participants who started second-line of treatment. | Posted | | Number | | participants | | Baseline up to approximately 35 months | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
| |
| Primary | Percentage of Participants With AEs by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 Intensity Grades | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of AEs were graded according to NCI CTCAE version 4.0 on a 5-point scale: Grade 1=Mild, intervention not indicated; Grade 2=Moderate, local or noninvasive intervention indicated; Grade 3=Severe or medically significant but not immediately life-threatening; Grade 4= Life-threatening consequences, urgent intervention indicated; and Grade 5=Death related to AE. Percentage of participants with AEs by maximum severity grades was reported. | Analysis was performed on the Safety population. | Posted | | Number | | percentage of participants | | Baseline up to 28 days after last study drug administration (up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
|
| Primary | Percentage of Participants With AEs Leading to Premature Discontinuation of Investigational Medicinal Products (IMPs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs leading to premature discontinuation of IMPs (pertuzumab and trastuzumab) was reported. AEs included both SAEs and non-SAEs. The 95% CI was computed using Clopper-Pearson method. | Analysis was performed on the Safety population. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to 28 days after last study drug administration (up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
|
| Primary | Percentage of Participants With AEs of Suspected Cardiac Origin, by New York Heart Association Classification (NYHA) | NYHA functional classification includes: Class I (no limitation in physical activity; ordinary physical activity does not cause fatigue, breathlessness or palpitation), Class II (slight limitation of physical activity; ordinary physical activity results in fatigue, palpitation, breathlessness or angina pectoris), Class III (marked limitation of physical activity; less than ordinary activity will lead to symptomatically 'moderate' heart failure) and Class IV (inability to carry out any physical activity without discomfort; symptoms of congestive cardiac failure are present even at rest). Percentage of participants with AEs suspected to be of cardiac origin by maximum NYHA classification was reported. | Analysis was performed on the Safety population. | Posted | | Number | | percentage of participants | | Baseline up to 28 days after last study drug administration (up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
|
| Primary | Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Below 50% | LVEF was assessed using echocardiography (ECHO) or multiple-gated acquisition (MUGA) scans. Percentage of participants with LVEF below 50% at any time during the study was reported. | Analysis was performed on the Safety population. | Posted | | Number | | percentage of participants | | Baseline up to 28 days after last study drug administration (up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Trastuzumab, Pertuzumab, and Taxane | Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator's choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure. |
| |