Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02491892




Registration number
NCT02491892
Ethics application status
Date submitted
11/06/2015
Date registered
8/07/2015
Date last updated
25/08/2015

Titles & IDs
Public title
A Study of Pertuzumab in Participants With Metastatic Breast Cancer
Scientific title
Open-Label, Phase II, Multicenter, Randomized Study of Efficacy and Safety for Two Different Doses of a Recombinant Humanized Antibody to HER2 (rhuMAb 2C4) Administered Every 3 Weeks to Patients With Metastatic Breast Cancer With Low Expression of HER2
Secondary ID [1] 0 0
BO16934
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pertuzumab

Experimental: Pertuzumab 1050 mg - Participants will not receive a loading dose, but will receive pertuzumab 1050 milligrams (mg) via intravenous (IV) infusion every 3 weeks until unacceptable toxicity or disease progression.

Experimental: Pertuzumab 420 mg - Participants will receive a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.


Treatment: Drugs: Pertuzumab
Participants will receive one of two IV treatment regimens with pertuzumab: either 420 mg every 3 weeks, with an initial 840-mg loading dose, or 1050 mg every 3 weeks with no loading dose administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
Timepoint [1] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [1] 0 0
Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR
Timepoint [1] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [2] 0 0
Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR
Timepoint [2] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [3] 0 0
Percentage of Participants Achieving a Best Overall Response of Confirmed CR
Timepoint [3] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [4] 0 0
Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR
Timepoint [4] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [5] 0 0
Number of Participants Who Experienced PD or Death
Timepoint [5] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [6] 0 0
Time to Progression
Timepoint [6] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [7] 0 0
Number of Participants Who Experienced PD or Withdrew From the Study Early
Timepoint [7] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [8] 0 0
Time to Treatment Failure
Timepoint [8] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [9] 0 0
Percentage of Participants Who Died
Timepoint [9] 0 0
Up to approximately 2 years (from start of treatment until death)
Secondary outcome [10] 0 0
Overall Survival
Timepoint [10] 0 0
Up to approximately 2 years (from start of treatment until death)
Secondary outcome [11] 0 0
Percentage of Participants Achieving a Best Overall Response of SD
Timepoint [11] 0 0
Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcome [12] 0 0
Apparent Half-Life (t1/2) of Pertuzumab
Timepoint [12] 0 0
Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Secondary outcome [13] 0 0
Maximum Plasma Concentration (Cmax) of Pertuzumab
Timepoint [13] 0 0
Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Secondary outcome [14] 0 0
Time to Maximum Plasma Concentration (Tmax) of Pertuzumab
Timepoint [14] 0 0
Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Secondary outcome [15] 0 0
Area Under the Concentration-Time Curve (AUC) of Pertuzumab
Timepoint [15] 0 0
Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Secondary outcome [16] 0 0
Systemic Clearance (CL) of Pertuzumab
Timepoint [16] 0 0
Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Secondary outcome [17] 0 0
Volume of Distribution at Steady State (Vss) of Pertuzumab
Timepoint [17] 0 0
Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Secondary outcome [18] 0 0
Mean Residence Time (MRT) of Pertuzumab
Timepoint [18] 0 0
Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Secondary outcome [19] 0 0
Number of Participants Experiencing a Drop in Left Ventricular Ejection Fraction (LVEF) to a Value of Less Than 50%
Timepoint [19] 0 0
Up to approximately 1 year (at Baseline; at the end of Cycles 2, 4, 8, 12, and 16; and up to 7 weeks following the last infusion)

Eligibility
Key inclusion criteria
* Females at least 18 years of age
* Histologically-confirmed metastatic breast cancer with low HER2 expression and at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Karnofsky performance status at least 80%
* Disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
* Left ventricular ejection fraction (LVEF) at least 50%
* Adequate liver function
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
* Pulmonary or central nervous system (CNS) metastases
* Chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of Day 1
* Previous treatment with any drug that targets the HER2 receptor family
* Previous treatment with corticosteroids as cancer therapy
* History of significant cardiac disease
* Major surgery or trauma within 4 weeks of Day 1
* Pregnant or lactating women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 2
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
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2005
Sample size
Target
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment hospital [3] 0 0
- Geelong
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Namur
Country [2] 0 0
Finland
State/province [2] 0 0
Helsinki
Country [3] 0 0
Finland
State/province [3] 0 0
Tampere
Country [4] 0 0
Germany
State/province [4] 0 0
Hamburg
Country [5] 0 0
Germany
State/province [5] 0 0
Herne
Country [6] 0 0
Germany
State/province [6] 0 0
München
Country [7] 0 0
Italy
State/province [7] 0 0
Milano
Country [8] 0 0
Italy
State/province [8] 0 0
Parma
Country [9] 0 0
Netherlands
State/province [9] 0 0
Amsterdam
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Valencia
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Edinburgh
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Manchester

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02491892