Pertuzumab for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Breast CancerPertuzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02019277) in the Trastuzumab, Pertuzumab, and Taxane ARM group. Side effects include: Diarrhoea with 70%, Fatigue with 68%, Neuropathy peripheral with 56%, Alopecia with 54%, Rash with 52%.

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