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Chemotherapy
Pertuzumab + Chemotherapy + Trastuzumab for Breast Cancer (APHINITY Trial)
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
Confirmed HER2 positive status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
APHINITY Trial Summary
This trial will study whether adding pertuzumab to standard chemotherapy and trastuzumab improves outcomes in patients with operable HER2-positive breast cancer.
Who is the study for?
This trial is for individuals with non-metastatic, operable HER2-positive primary breast cancer. Participants must have completed surgery within the last 8 weeks and be able to start chemotherapy within 7 days of joining. They should have a normal heart function (LVEF ≥55%), an ECOG performance status ≤1, known hormone receptor status, and agree to use effective contraception. Exclusions include prior breast cancer or systemic cancer treatments, current pregnancy or lactation, other serious illnesses that could interfere with treatment, and sensitivity to study drugs.Check my eligibility
What is being tested?
The trial is testing the effectiveness of adding Pertuzumab to a standard adjuvant therapy regimen for HER2-positive breast cancer patients. This includes Trastuzumab and various chemotherapies like Cyclophosphamide and Paclitaxel in a randomized comparison against placebo plus the same additional therapies. The goal is to see if Pertuzumab improves outcomes when used alongside these existing treatments.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, heart problems due to Trastuzumab or Pertuzumab, infusion-related reactions from any administered drugs, as well as common chemotherapy side effects such as fatigue, nausea/vomiting, hair loss (alopecia), low blood cell counts leading to increased infection risk or bleeding complications.
APHINITY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My cancer is HER2 positive.
Select...
I agree to use effective birth control during and for 7 months after the study.
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My breast cancer is HER2-positive, hasn't spread, and was surgically removed.
APHINITY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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
Secondary outcome measures
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
+25 moreSide effects data
From 2016 Phase 3 trial • 50 Patients • NCT0201927770%
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%
Nail disorder
24%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Arthralgia
22%
Pain in extremity
20%
Back pain
20%
Urinary tract infection
18%
Dizziness
18%
Cough
18%
Constipation
16%
Neutropenia
16%
Dry skin
14%
Pyrexia
14%
Paronychia
14%
Dysgeusia
14%
Oropharyngeal pain
14%
Pruritus
14%
Hot flush
12%
Hypertension
12%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
10%
Peripheral sensory neuropathy
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
8%
Febrile neutropenia
8%
Rash pustular
8%
Lacrimation increased
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Syncope
2%
Psychotic disorder
2%
Dermatitis bullous
2%
Gastroenteritis
2%
Femur fracture
2%
Breast cancer
2%
Device related infection
2%
Wound infection
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab, Pertuzumab, and Taxane
APHINITY Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pertuzumab + Trastuzumab + ChemotherapyExperimental Treatment9 Interventions
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).
Group II: Placebo + Trastuzumab + ChemotherapyPlacebo Group9 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Epirubicin
2012
Completed Phase 4
~19470
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab
2014
Completed Phase 4
~5190
Cyclophosphamide
1995
Completed Phase 3
~3780
Docetaxel
1995
Completed Phase 4
~5620
Doxorubicin
2012
Completed Phase 3
~7940
5-Fluorouracil
2012
Completed Phase 3
~7800
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
562,885 Total Patients Enrolled
96 Trials studying Breast Cancer
18,414 Patients Enrolled for Breast Cancer
Breast International GroupOTHER
33 Previous Clinical Trials
49,772 Total Patients Enrolled
15 Trials studying Breast Cancer
28,959 Patients Enrolled for Breast Cancer
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,084,250 Total Patients Enrolled
159 Trials studying Breast Cancer
86,663 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer other than specific skin cancers or early-stage cervical or colon cancer in the last 5 years.You are currently receiving experimental treatment for cancer in another research study.You are allergic to any of the study medications or their ingredients.I am fully active and can carry on all my pre-disease activities without restriction.I have a serious heart or blood vessel condition.I started chemotherapy within 8 weeks after my breast cancer surgery.My cancer is HER2 positive.I know my cancer's hormone receptor status.My cancer has not spread to the lymph nodes.I agree to use effective birth control during and for 7 months after the study.Your heart's pumping ability, measured by a special heart test, is at least 55%.My cancer is classified as T4, indicating it is advanced.I have had chemotherapy or radiotherapy for cancer before.I have previously used anti-HER2 or other biologic/immunotherapy for cancer.I have had breast cancer before, on either or both sides.My breast cancer is HER2-positive, hasn't spread, and was surgically removed.I do not have severe lung problems that could affect my treatment.Your recent lab tests show abnormal results.
Research Study Groups:
This trial has the following groups:- Group 1: Pertuzumab + Trastuzumab + Chemotherapy
- Group 2: Placebo + Trastuzumab + Chemotherapy
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other Pertuzumab research projects being conducted?
"Pertuzumab is being trialled in 2629 studies, 665 of which are still ongoing. Out of those 119850 locations, many of the trials for Pertuzumab originate from Seattle, Washington."
Answered by AI
Has Pertuzumab been cleared by the FDA?
"Pertuzumab is classified as a 3 on Power's safety scale. This means that while there is still some testing required to determine efficacy, the medication has undergone multiple rounds of clinical trials which have all support its safety."
Answered by AI
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