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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01572038
Ethics application status
Date submitted
3/04/2012
Date registered
5/04/2012
Date last updated
13/01/2020

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
Percentage of Participants With AEs Leading to Study Treatment Interruption and Discontinuation
Timepoint [1] 0 0
Baseline up to approximately 7 years 3 months
Primary outcome [2] 0 0
Percentage of Participants who Died, Reported by Cause of Death
Timepoint [2] 0 0
Baseline up to approximately 7 years 3 months
Primary outcome [3] 0 0
Percentage of Participants with Congestive Heart Failure (CHF)
Timepoint [3] 0 0
Baseline up to approximately 7 years 3 months
Primary outcome [4] 0 0
Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs)
Timepoint [4] 0 0
Baseline up to approximately 7 years 3 months
Primary outcome [5] 0 0
Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study
Timepoint [5] 0 0
Screening, every 3 cycles (cycle length=3 weeks) prior to study drug administration during treatment period, 1 month post-treatment safety follow-up (approximately 7 years 3 months overall)
Primary outcome [6] 0 0
Time to Onset of the First Episode of CHF
Timepoint [6] 0 0
Baseline up to approximately 7 years 3 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Timepoint [1] 0 0
Screening to disease progression or death (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
Screening up to death due to any cause (up to approximately 7 years 3 months)
Secondary outcome [3] 0 0
Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]) Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v1.1
Timepoint [3] 0 0
Screening to disease progression or death (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Secondary outcome [4] 0 0
Percentage of Response with Clinical Benefit Response (CR, PR or Stable Disease [SD; for At Least 6 months] Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v.1.1
Timepoint [4] 0 0
Screening to disease progression or death (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Secondary outcome [5] 0 0
Duration of Response as Assessed by Investigator Based on RECIST v1.1
Timepoint [5] 0 0
Screening to disease progression or death (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Secondary outcome [6] 0 0
Time to Response Among Participants with Best Response of PR or CR as Assessed by Investigator Based on RECIST v1.1
Timepoint [6] 0 0
Screening to disease progression or death (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Secondary outcome [7] 0 0
Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores for Female Participants Only
Timepoint [7] 0 0
Screening, every 3 cycles (cycle length=3 weeks) during treatment period, 1 and 3 months post-treatment safety follow-up (approximately 7 years 3 months overall)

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
Gender
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
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Algiers
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Argentina
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La Rioja
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Argentina
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Rosario
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Austria
State/province [4] 0 0
Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Steyr
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Wien
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Brussel
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Edegem
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Gent
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Belgium
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Leuven
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Liège
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RS
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Nova Scotia
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Quebec
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Beijing
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Xi'an
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Portoviejo
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Ecuador
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Quito
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Egypt
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Cairo
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Tallinn
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Estonia
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Tartu
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Finland
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Helsinki
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Finland
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Pori
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Tampere
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Turku
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Amiens
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Dechy
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Saarbruecken
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Patras
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Thessaloniki
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????a
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Hong Kong
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Budapest
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Debrecen
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Hungary
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Miskolc
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Szeged
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Holon
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Petach Tikva
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Ramat Gan
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Emilia-Romagna
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Lazio
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Marche
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Kaunas
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Vilnius
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Mexico
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D.f.
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Distrito Federal
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Rabat
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Dordrecht
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Islamabad
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Lima
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Bialystok
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Kielce
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Kraków
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Otwock
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Evora
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Lisboa
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Loures
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Porto
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Riyadh
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Alicante
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Asturias
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Barcelona
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Huesca
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LA Coruña
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LA Rioja
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LAS Palmas
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Leon
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Orense
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Salamanca
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Sevilla
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Spain
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Valladolid
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Spain
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Zaragoza
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Gävle
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Karlstad
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Lund
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Vaxjo
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Edirne
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Dnipropetrovsk
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Kiev
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Lviv
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Zaporozhye
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United Arab Emirates
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Bath
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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
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and
tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane
(docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with
metastatic or locally recurrent HER2-positive breast cancer. Participants will receive
pertuzumab intravenously (IV) 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.
Trial website
https://clinicaltrials.gov/show/NCT01572038
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

Summary results
Other publications