Clinical trial • Phase III • Oncology

PERTUZUMAB for Breast cancer | Early HER2-positive breast cancer

Phase III trial of PERTUZUMAB for Breast cancer | Early HER2-positive breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer | Early HER2-positive breast cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-03-2024
First CTIS Authorization Date
25-04-2024

Trial design

Randomised, open-label, arm a: trastuzumab plus pertuzumab plus docetaxel (3 cycles) (hpt) followed by three 3-weekly cycles of fec; arm b: weekly or 3-weekly trastuzumab plus pertuzumab plus 3-weekly docetaxel (3 cycles) (hpt) followed by three 3-weekly cycles of fec, followed by single-agent trastuzumab to complete 1 year of trastuzumab administration-controlled Phase III trial across 6 sites in Finland, Sweden.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: Trastuzumab plus pertuzumab plus docetaxel (3 cycles) (HPT) followed by three 3-weekly cycles of FEC; Arm B: Weekly or 3-weekly trastuzumab plus pertuzumab plus 3-weekly docetaxel (3 cycles) (HPT) followed by three 3-weekly cycles of FEC, followed by single-agent trastuzumab to complete 1 year of trastuzumab administration
Target Sample Size
520
Trial Duration For Participant
365

Eligibility

Recruits 520 No vulnerable population selected; only adult women (> 18 years) enrolled. No consent/assent information provided..

Vulnerable Population
No vulnerable population selected; only adult women (> 18 years) enrolled. No consent/assent information provided.

Inclusion criteria

  • {"criterion_text":"- Woman > 18 years of age, confirmed invasive HER2-positive breast cancer"}

Exclusion criteria

  • {"criterion_text":"- Presence of distant metastases, clinically significant cardiac disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Invasive disease-free survival","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall survival\n- Distant disease-free survival\n- Left ventricle ejection fractions\n- Adverse event rate\n- Quality of life","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
520
Recruitment Window Months
113
Consent Approach
Informed consent provided by adult participants; no assent or paediatric consent information provided.

Geography

Total Number Of Sites
6
Total Number Of Participants
520

Finland

Earliest CTIS Part Ii Submission Date
13-04-2024
Latest Decision Or Authorization Date
25-04-2024
Processing Time Days
12
Number Of Sites
5
Number Of Participants
470

Sites

Site Name
Turku University Hospital
Department Name
Oncology
Contact Person Name
Riikka Huovinen
Contact Person Email
riikka.huovinen@tyks.fi
Site Name
Pirkanmaan hyvinvointialue
Department Name
Oncology
Contact Person Name
Pirkko-Liisa Kellokumpu-Lehtinen
Site Name
Kuopio University Hospital
Department Name
Oncology
Contact Person Name
Päivi Auvinen
Contact Person Email
paivi.auvinen@kuh.fi
Site Name
HUS-Yhtymae
Department Name
Oncology
Contact Person Name
Johanna Mattson
Contact Person Email
johanna.mattson@hus.fi
Site Name
Oulu University Hospital
Department Name
Oncology
Contact Person Name
Taina Turpeenniemi-Hujanen

Sweden

Earliest CTIS Part Ii Submission Date
13-04-2024
Latest Decision Or Authorization Date
25-04-2024
Processing Time Days
12
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Uppsala University Hospital
Department Name
Oncology
Contact Person Name
Henrik Lindman
Contact Person Email
henrik.lindman@igp.uu.se

Sponsor

Primary sponsor

Full Name
HUS-Yhtymae
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
Perjeta 420 mg concentrate for solution for infusion
Active Substance
PERTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (EU marketing authorisation EU/1/13/813/001)
Maximum Dose
840 mg (max daily); 1680 mg (max total)
Investigational Product Name
PERTUZUMAB
Active Substance
PERTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Investigational / no marketing authorisation number provided in record
Maximum Dose
840 mg (max daily); 1680 mg (max total)
Combination Treatment
Yes

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