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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01358877




Registration number
NCT01358877
Ethics application status
Date submitted
20/05/2011
Date registered
24/05/2011
Date last updated
19/09/2024

Titles & IDs
Public title
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
Scientific title
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Secondary ID [1] 0 0
TOC4939G
Secondary ID [2] 0 0
BO25126
Universal Trial Number (UTN)
Trial acronym
APHINITY
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 - 5-Fluorouracil
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Docetaxel
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Epirubicin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pertuzumab
Treatment: Drugs - Placebo
Treatment: Drugs - Trastuzumab

Experimental: Pertuzumab + Trastuzumab + Chemotherapy - Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).

Placebo comparator: Placebo + Trastuzumab + Chemotherapy - Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram \[mg/kg\] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m\^2) + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 milligrams \[mg\]).


Treatment: Drugs: 5-Fluorouracil
5-Fluorouracil will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Carboplatin
Carboplatin will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Docetaxel
Docetaxel will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Doxorubicin
Doxorubicin will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Epirubicin
Epirubicin will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Pertuzumab
Pertuzumab will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Placebo
Placebo will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Trastuzumab
Trastuzumab will be administered as per the schedule specified in the respective arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [1] 0 0
Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Primary outcome [2] 0 0
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [1] 0 0
Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Secondary outcome [2] 0 0
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [3] 0 0
Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Secondary outcome [4] 0 0
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Percentage of Participants Who Died
Timepoint [5] 0 0
Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Secondary outcome [6] 0 0
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [7] 0 0
Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Secondary outcome [8] 0 0
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [9] 0 0
Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Secondary outcome [10] 0 0
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Timepoint [10] 0 0
3 years
Secondary outcome [11] 0 0
Percentage of Participants With Primary Cardiac Event
Timepoint [11] 0 0
Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
Secondary outcome [12] 0 0
Percentage of Participants With Secondary Cardiac Event
Timepoint [12] 0 0
Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
Secondary outcome [13] 0 0
Change From Baseline in LVEF to Worst Post-Baseline Value
Timepoint [13] 0 0
Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
Secondary outcome [14] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
Timepoint [14] 0 0
Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36
Secondary outcome [15] 0 0
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
Timepoint [15] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [16] 0 0
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
Timepoint [16] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [17] 0 0
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
Timepoint [17] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [18] 0 0
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
Timepoint [18] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [19] 0 0
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
Timepoint [19] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [20] 0 0
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
Timepoint [20] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [21] 0 0
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
Timepoint [21] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [22] 0 0
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
Timepoint [22] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [23] 0 0
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
Timepoint [23] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [24] 0 0
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
Timepoint [24] 0 0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Secondary outcome [25] 0 0
Trough Serum Concentration (Cmin) of Pertuzumab
Timepoint [25] 0 0
Cycles 1, 10 and 15 (Cycle length=21 days)
Secondary outcome [26] 0 0
Cmin of Trastuzumab
Timepoint [26] 0 0
Cycles 1, 10 and 15 (Cycle length=21 days)
Secondary outcome [27] 0 0
Peak Serum Concentration (Cmax) of Pertuzumab
Timepoint [27] 0 0
Cycles 1, 10 and 15 (Cycle length=21 days)
Secondary outcome [28] 0 0
Cmax of Trastuzumab
Timepoint [28] 0 0
Cycles 1, 10 and 15 (Cycle length=21 days)

Eligibility
Key inclusion criteria
* Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
* Known hormone receptor status (estrogen receptor and progesterone receptor)
* The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
* Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
* Confirmed HER2 positive status
* Completion of all necessary baseline laboratory and radiologic investigations prior to randomization
* Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of any prior (ipsi- and/or contralateral) invasive breast cancer
* History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
* Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer
* Any node-negative tumor
* Any previous systemic chemotherapy for cancer or radiotherapy for cancer
* Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
* Concurrent anti-cancer treatment in another investigational trial
* Serious cardiac or cardiovascular disease or condition
* Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
* Abnormal laboratory tests immediately prior to randomization
* Pregnant or lactating women
* Sensitivity to any of the study medications or any of the ingredients or excipients of these medications

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/11/2024
Actual
Sample size
Target
Accrual to date
Final
4804
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Lismore Base Hospital; Cancer Care & Haematology Unit - Lismore
Recruitment hospital [2] 0 0
Mater Misericordiae Hospital; Chemotherapy Cottage - Sydney
Recruitment hospital [3] 0 0
Newcastle Mater Misericordiae Hospital; Oncology - Waratah
Recruitment hospital [4] 0 0
Westmead Hospital; Medical Oncology and Pallative Care - Westmead
Recruitment hospital [5] 0 0
Wesley Medical Centre; Clinic For Haematology and Oncology - Auchenflower
Recruitment hospital [6] 0 0
Mater Hospital; Oncology - Brisbane
Recruitment hospital [7] 0 0
Royal Adelaide Hospital; Oncology - Adelaide
Recruitment hospital [8] 0 0
Royal Hobart Hospital; Medical Oncology - Hobart
Recruitment hospital [9] 0 0
Monash Medical Centre; Oncology - Clayton
Recruitment hospital [10] 0 0
Geelong Hospital; Andrew Love Cancer Centre - Geelong
Recruitment hospital [11] 0 0
Austin Hospital; Medical Oncology - Heidelberg
Recruitment hospital [12] 0 0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital; Medical Oncology - Perth
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2060 - Sydney
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
4101 - Brisbane
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment postcode(s) [12] 0 0
3000 - Melbourne
Recruitment postcode(s) [13] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Idaho
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Illinois
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Iowa
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Kansas
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Louisiana
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Maine
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Maryland
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Mississippi
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Missouri
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Nebraska
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Harbin
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Nanchang
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China
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Shanghai City
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China
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Shanghai
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China
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Shijiazhuang
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Wuhan
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Colombia
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Bogota
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Medellin
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Monteria
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Croatia
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Split
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Croatia
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Varazdin
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Zagreb
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Pardubice
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Denmark
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Aalborg
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Esbjerg
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Herlev
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Hillerod
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København Ø
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Naestved
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Denmark
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Odense C
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Denmark
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Roskilde
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Denmark
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Vejle
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El Salvador
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Salvador
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El Salvador
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San Salvador
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Amiens
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Angers
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France
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Breast International Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
Trial website
https://clinicaltrials.gov/study/NCT01358877
Trial related presentations / publications
Gelber RD, Wang XV, Cole BF, Cameron D, Cardoso F, Tjan-Heijnen V, Krop I, Loi S, Salgado R, Kiermaier A, Frank E, Fumagalli D, Caballero C, de Azambuja E, Procter M, Clark E, Restuccia E, Heeson S, Bines J, Loibl S, Piccart-Gebhart M; APHINITY Steering Committee and Investigators. Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. Eur J Cancer. 2022 May;166:219-228. doi: 10.1016/j.ejca.2022.01.031. Epub 2022 Mar 18.
Bines J, Clark E, Barton C, Restuccia E, Procter M, Sonnenblick A, Fumagalli D, Parlier D, Arahmani A, Baselga J, Viale G, Reaby LL, Frank E, Gelber RD, Piccart M, Jackisch C, Petersen JA. Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer. Br J Cancer. 2021 Jul;125(1):38-47. doi: 10.1038/s41416-021-01323-y. Epub 2021 Apr 7.
Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pienkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448-1457. doi: 10.1200/JCO.20.01204. Epub 2021 Feb 4.
Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators. Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5.
Luo Y, Li W, Jiang Z, Zhang Q, Wang L, Mao Y, Tjan-Heijnen VCG, Im SA, McConnell R, Bejarano S, Fumagalli D, Bines J, Wang B, Garg A, Kirschbrown WP, Xu B. Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer. Anticancer Drugs. 2019 Sep;30(8):866-872. doi: 10.1097/CAD.0000000000000808.
Kirschbrown WP, Kagedal M, Wang B, Lindbom L, Knott A, Mack R, Monemi S, Nijem I, Girish S, Freeman C, Fumagalli D, McConnell R, Jerusalem G, Twelves C, Baselga J, von Minckwitz G, Bines J, Garg A. Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study. Cancer Chemother Pharmacol. 2019 Jun;83(6):1147-1158. doi: 10.1007/s00280-019-03826-1. Epub 2019 Apr 11.
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Public notes

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Hoffmann-La Roche
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01358877