Study Summary
This trial will study whether adding pertuzumab to standard chemotherapy and trastuzumab improves outcomes in patients with operable HER2-positive breast cancer.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 28 Secondary · Reporting Duration: 3 years
3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3
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
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
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
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
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
Month 59
Change From Baseline in LVEF to Worst Post-Baseline Value
Percentage of Participants With Primary Cardiac Event
Percentage of Participants With Secondary Cardiac Event
Month 18
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
Anxiety
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
Month 18
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
Day 21
Cmax of Trastuzumab
Cmin of Trastuzumab
Peak Serum Concentration (Cmax) of Pertuzumab
Trough Serum Concentration (Cmin) of Pertuzumab
Month 59
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Month 59
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
Month 59
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Month 59
Percentage of Participants Who Died
Month 59
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Month 59
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Trastuzumab, Pertuzumab, and Taxane
70%Diarrhoea
68%Fatigue
56%Neuropathy peripheral
54%Alopecia
52%Rash
46%Nausea
38%Upper respiratory tract infection
36%Myalgia
34%Vomiting
34%Headache
28%Muscle spasms
24%Epistaxis
24%Gastrooesophageal reflux disease
24%Nail disorder
24%Arthralgia
22%Pain in extremity
20%Urinary tract infection
20%Back pain
18%Dizziness
18%Cough
18%Constipation
16%Dry skin
16%Neutropenia
14%Dysgeusia
14%Oropharyngeal pain
14%Paronychia
14%Pyrexia
14%Pruritus
14%Hot flush
12%Dyspnoea
12%Hypertension
12%Insomnia
12%Decreased appetite
12%Stomatitis
12%Dry eye
12%Musculoskeletal pain
10%Peripheral sensory neuropathy
10%Mucosal inflammation
10%Abdominal pain
10%Lethargy
8%Anxiety
8%Oedema peripheral
8%Acne
8%Rhinorrhoea
8%Erythema
8%Oral candidiasis
8%Lacrimation increased
8%Febrile neutropenia
8%Chills
8%Anaemia
8%Sinusitis
8%Rash pustular
6%Lymphoedema
6%Dyspepsia
6%Chest discomfort
6%Hypocalcaemia
6%Chest pain
6%Depression
6%Nail infection
6%Bone pain
6%Dermatitis acneiform
6%Tachycardia
6%Conjunctivitis
6%Abdominal pain upper
6%Pain
6%Dry mouth
6%Dyspnoea exertional
6%Weight decreased
6%Tooth extraction
6%Skin lesion
6%Injection site reaction
6%Musculoskeletal chest pain
4%Cellulitis
4%Pulmonary embolism
2%Drug hypersensitivity
2%Psychotic disorder
2%Breast cancer
2%Syncope
2%Gastritis
2%Device related infection
2%Dermatomyositis
2%Cardiac failure
2%Femur fracture
2%Gastroenteritis
2%Dermatitis bullous
2%Oesophagitis
2%Sepsis
2%Wound infection
Trial Design
2 Treatment Groups
Pertuzumab + Trastuzumab + Chemotherapy
1 of 2
Placebo + Trastuzumab + Chemotherapy
1 of 2
Experimental Treatment
Non-Treatment Group
4804 Total Participants · 2 Treatment Groups
Primary Treatment: Pertuzumab · Has Placebo Group · Phase 3
Pertuzumab + Trastuzumab + ChemotherapyExperimental Group · 9 Interventions: Paclitaxel, 5-Fluorouracil, Carboplatin, Doxorubicin, Cyclophosphamide, Docetaxel, Epirubicin, Pertuzumab, Trastuzumab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Placebo + Trastuzumab + ChemotherapyPlaceboComparator Group · 9 Interventions: Paclitaxel, Placebo, 5-Fluorouracil, Carboplatin, Doxorubicin, Cyclophosphamide, Docetaxel, Epirubicin, Trastuzumab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Fluorouracil
FDA approved
Carboplatin
FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Docetaxel
FDA approved
Epirubicin
FDA approved
Pertuzumab
FDA approved
Trastuzumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Who is running the clinical trial?
Breast International GroupOTHER
33 Previous Clinical Trials
50,142 Total Patients Enrolled
15 Trials studying Breast Cancer
28,959 Patients Enrolled for Breast Cancer
Hoffmann-La RocheLead Sponsor
2,361 Previous Clinical Trials
1,063,279 Total Patients Enrolled
154 Trials studying Breast Cancer
85,472 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,497 Previous Clinical Trials
559,875 Total Patients Enrolled
96 Trials studying Breast Cancer
18,467 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,148 Previous Clinical Trials
871,369 Total Patients Enrolled
133 Trials studying Breast Cancer
66,314 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have HER2-positive invasive breast cancer that is surgically resectable.
The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days)
You have HER2-positive breast cancer.
You are of childbearing potential and/or your partner is of childbearing potential.
References
- Bines, José, Marion Procter, Eleonora Restuccia, Giuseppe Viale, Dimitrios Zardavas, Thomas Suter, Amal Arahmani, et al.. 2020. “Incidence and Management of Diarrhea with Adjuvant Pertuzumab and Trastuzumab in Patients with Human Epidermal Growth Factor Receptor 2-positive Breast Cancer”. Clinical Breast Cancer. Elsevier BV. doi:10.1016/j.clbc.2019.06.016.
- Bines, José, Emma Clark, Claire Barton, Eleonora Restuccia, Marion Procter, Amir Sonnenblick, Debora Fumagalli, et al.. 2021. “Patient-reported Function, Health-related Quality of Life, and Symptoms in APHINITY: Pertuzumab Plus Trastuzumab and Chemotherapy in Her2-positive Early Breast Cancer”. British Journal of Cancer. Springer Science and Business Media LLC. doi:10.1038/s41416-021-01323-y.
- Kirschbrown, Whitney P., Matts Kågedal, Bei Wang, Lars Lindbom, Adam Knott, Rachelle Mack, Sharareh Monemi, et al.. 2019. “Pharmacokinetic and Exploratory Exposure–response Analysis of Pertuzumab in Patients with Operable Her2-positive Early Breast Cancer in the APHINITY Study”. Cancer Chemotherapy and Pharmacology. Springer Science and Business Media LLC. doi:10.1007/s00280-019-03826-1.
- von Minckwitz, Gunter, Marion Procter, Evandro de Azambuja, Dimitrios Zardavas, Mark Benyunes, Giuseppe Viale, Thomas Suter, et al.. 2017. “Adjuvant Pertuzumab and Trastuzumab in Early Her2-positive Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1703643.
- Luo, Yang, Wei Li, Zefei Jiang, Qingyuan Zhang, Liwei Wang, Yixiang Mao, Vivianne C.G. Tjan-Heijnen, et al.. 2019. “Pharmacokinetics of Pertuzumab Administered Concurrently with Trastuzumab in Chinese Patients with Her2-positive Early Breast Cancer”. Anti-cancer Drugs. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/cad.0000000000000808.
- von Minckwitz, Gunter, Marion Procter, Evandro de Azambuja, Dimitrios Zardavas, Mark Benyunes, Giuseppe Viale, Thomas Suter, et al.. 2017. “Adjuvant Pertuzumab and Trastuzumab in Early Her2-positive Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1703643.
- Piccart, Martine, Marion Procter, Debora Fumagalli, Evandro de Azambuja, Emma Clark, Michael S. Ewer, Eleonora Restuccia, et al.. 2021. “Adjuvant Pertuzumab and Trastuzumab in Early Her2-positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-up”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.01204.
- Gelber, Richard D., Xin V. Wang, Bernard F. Cole, David Cameron, Fatima Cardoso, Vivianne Tjan-Heijnen, Ian Krop, et al.. 2022. “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”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2022.01.031.
- Gelber, Richard D., Xin V. Wang, Bernard F. Cole, David Cameron, Fatima Cardoso, Vivianne Tjan-Heijnen, Ian Krop, et al.. 2022. “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”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2022.01.031.
- von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5. Erratum In: N Engl J Med. 2017 Aug 17;377(7):702. N Engl J Med. 2018 Oct 18;379(16):1585.
- 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.
- 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.
- 2011. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01358877.
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