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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01572038




Registration number
NCT01572038
Ethics application status
Date submitted
3/04/2012
Date registered
5/04/2012
Date last updated
25/09/2020

Titles & IDs
Public title
A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer
Scientific title
A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Secondary ID [1] 0 0
2011-005334-20
Secondary ID [2] 0 0
MO28047
Universal Trial Number (UTN)
Trial acronym
PERUSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Docetaxel
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pertuzumab
Treatment: Drugs - Trastuzumab

Experimental: Pertuzumab + Trastuzumab + Taxane - Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.


Treatment: Drugs: Docetaxel
Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Treatment: Drugs: Nab-paclitaxel
Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Treatment: Drugs: Paclitaxel
Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Treatment: Drugs: Pertuzumab
Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.

Treatment: Drugs: Trastuzumab
Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
Timepoint [1] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [2] 0 0
Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term)
Timepoint [2] 0 0
The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Primary outcome [3] 0 0
Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term)
Timepoint [3] 0 0
The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Primary outcome [4] 0 0
Number of Participants With Grade =3 Treatment-Emergent Adverse Events, Occurring in =1% of Participants by System Organ Class and Preferred Term
Timepoint [4] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [5] 0 0
Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =10% of Participants by System Organ Class
Timepoint [5] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [6] 0 0
Number of Participants With Grade =3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =0.5% of Participants by Preferred Term
Timepoint [6] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [7] 0 0
Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =0.2% of Participants by Preferred Term
Timepoint [7] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [8] 0 0
Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =0.5% of Participants by Preferred Term
Timepoint [8] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [9] 0 0
Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in =5% of Participants by Category
Timepoint [9] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [10] 0 0
Number of Participants With Grade =3 Treatment-Emergent Adverse Events to Monitor, Occurring in =0.5% of Participants by Category and Preferred Term
Timepoint [10] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [11] 0 0
Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term
Timepoint [11] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [12] 0 0
Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
Timepoint [12] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [13] 0 0
Subgroup Analysis by Age (=65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade =3 TEAEs, Any-Grade and Grade =3 TEAEs Related to Pertuzumab, and TEAEs to Monitor
Timepoint [13] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [14] 0 0
Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade =3 TEAEs, Any-Grade and Grade =3 TEAEs Related to Pertuzumab, and TEAEs to Monitor
Timepoint [14] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [15] 0 0
Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
Timepoint [15] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [16] 0 0
Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
Timepoint [16] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [17] 0 0
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
Timepoint [17] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [18] 0 0
Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
Timepoint [18] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [19] 0 0
Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
Timepoint [19] 0 0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [20] 0 0
Number of Participants With a Congestive Heart Failure Event
Timepoint [20] 0 0
From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [21] 0 0
Time to Onset of the First Episode of Congestive Heart Failure
Timepoint [21] 0 0
From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [22] 0 0
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study
Timepoint [22] 0 0
Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [23] 0 0
Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study
Timepoint [23] 0 0
Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [24] 0 0
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0
Timepoint [24] 0 0
Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [25] 0 0
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria
Timepoint [25] 0 0
Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [26] 0 0
Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0
Timepoint [26] 0 0
Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Primary outcome [27] 0 0
Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria
Timepoint [27] 0 0
Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Secondary outcome [1] 0 0
Progression-Free Survival, as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [1] 0 0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [2] 0 0
Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Timepoint [2] 0 0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [3] 0 0
Subgroup Analysis by Age (=65 vs. >65 Years): Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Timepoint [3] 0 0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [4] 0 0
Subgroup Analysis by ECOG Performance Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Timepoint [4] 0 0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [5] 0 0
Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Timepoint [5] 0 0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [6] 0 0
Subgroup Analysis by Visceral Disease at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Timepoint [6] 0 0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [7] 0 0
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Timepoint [7] 0 0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [8] 0 0
Subgroup Analysis by Hormone Receptor Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Timepoint [8] 0 0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [9] 0 0
Subgroup Analysis by Previous Trastuzumab Therapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Timepoint [9] 0 0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [10] 0 0
Overall Survival
Timepoint [10] 0 0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [11] 0 0
Subgroup Analysis by Region of Enrollment: Overall Survival
Timepoint [11] 0 0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [12] 0 0
Subgroup Analysis by Age (=65 vs. >65 Years): Overall Survival
Timepoint [12] 0 0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [13] 0 0
Subgroup Analysis by ECOG Performance Status at Baseline: Overall Survival
Timepoint [13] 0 0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [14] 0 0
Subgroup Analysis by Taxane Chemotherapy: Overall Survival
Timepoint [14] 0 0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [15] 0 0
Subgroup Analysis by Visceral Disease at Baseline: Overall Survival
Timepoint [15] 0 0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [16] 0 0
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overall Survival
Timepoint [16] 0 0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [17] 0 0
Subgroup Analysis by Hormone Receptor Status at Baseline: Overall Survival
Timepoint [17] 0 0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [18] 0 0
Subgroup Analysis by Previous Trastuzumab Therapy: Overall Survival
Timepoint [18] 0 0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [19] 0 0
Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1
Timepoint [19] 0 0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [20] 0 0
Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1
Timepoint [20] 0 0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [21] 0 0
Subgroup Analysis by Age (=65 vs. >65 Years): Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1
Timepoint [21] 0 0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [22] 0 0
Subgroup Analysis by Taxane Chemotherapy: Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1
Timepoint [22] 0 0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [23] 0 0
Clinical Benefit Rate (CR or PR, or SD for at Least 6 Months) Based on Best Overall Response as Assessed by the Investigator Using RECIST v.1.1
Timepoint [23] 0 0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [24] 0 0
Duration of Response as Assessed by the Investigator Using RECIST v1.1
Timepoint [24] 0 0
From date of first confirmed response (CR or PR) to first documented disease progression or death from any cause, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [25] 0 0
Time to Response for Participants With Best Overall Response of Complete Response or Partial Response, as Assessed by the Investigator Using RECIST v1.1
Timepoint [25] 0 0
From date of first study treatment until date of first confirmed response (CR or PR). The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Secondary outcome [26] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study
Timepoint [26] 0 0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Secondary outcome [27] 0 0
Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study
Timepoint [27] 0 0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Secondary outcome [28] 0 0
Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study
Timepoint [28] 0 0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Secondary outcome [29] 0 0
Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study
Timepoint [29] 0 0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Secondary outcome [30] 0 0
Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study
Timepoint [30] 0 0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Secondary outcome [31] 0 0
Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study
Timepoint [31] 0 0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
* HER2-positive breast cancer
* Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* LVEF of at least 50 percent (%)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (</=) 6 months
* Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
* Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
* History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
* Central nervous system (CNS) metastases
* Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
* History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
* Inadequate bone marrow, liver or renal function
* Uncontrolled hypertension
* Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2019
Sample size
Target
Accrual to date
Final
1436
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Canberra Hospital; Medical Oncology - Canberra
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital; Medical Oncology - Camperdown
Recruitment hospital [3] 0 0
HOCA Chermside - Chermside
Recruitment hospital [4] 0 0
Mater Hospital; Cancer Services - South Brisbane
Recruitment hospital [5] 0 0
Austin and Repatriation Medical Centre; Cancer Services - Melbourne
Recruitment hospital [6] 0 0
Royal Melbourne Hospital; Hematology and Medical Oncology - Parkville
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3084 - Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Algeria
State/province [1] 0 0
Algiers
Country [2] 0 0
Argentina
State/province [2] 0 0
La Rioja
Country [3] 0 0
Argentina
State/province [3] 0 0
Rosario
Country [4] 0 0
Austria
State/province [4] 0 0
Graz
Country [5] 0 0
Austria
State/province [5] 0 0
Innsbruck
Country [6] 0 0
Austria
State/province [6] 0 0
Linz
Country [7] 0 0
Austria
State/province [7] 0 0
Salzburg
Country [8] 0 0
Austria
State/province [8] 0 0
Steyr
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussel
Country [11] 0 0
Belgium
State/province [11] 0 0
Edegem
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
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Caracas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01572038