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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

Must not have

Any 'clinical' T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer

Any node-negative tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all my pre-disease activities without restriction.

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My cancer is HER2 positive.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is classified as T4, indicating it is advanced.

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My cancer has not spread to the lymph nodes.

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I have had chemotherapy or radiotherapy for cancer before.

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I have previously used anti-HER2 or other biologic/immunotherapy for cancer.

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I have had breast cancer before, on either or both sides.

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I have a serious heart or blood vessel condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

+21 more

Side effects data

From 2016 Phase 3 trial • 50 Patients • NCT02019277

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%

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

Lacrimation increased

Febrile neutropenia

Rash pustular

Chills

Anaemia

Oedema peripheral

Oral candidiasis

Sinusitis

Anxiety

Rhinorrhoea

Acne

Erythema

Musculoskeletal chest pain

Injection site reaction

Skin lesion

Conjunctivitis

Nail infection

Chest pain

Tachycardia

Abdominal pain upper

Dry mouth

Dyspepsia

Chest discomfort

Pain

Hypocalcaemia

Bone pain

Depression

Dyspnoea exertional

Dermatitis acneiform

Lymphoedema

Weight decreased

Tooth extraction

Pulmonary embolism

Cellulitis

Device related infection

Gastroenteritis

Wound infection

Femur fracture

Breast cancer

Syncope

Psychotic disorder

Dermatitis bullous

Cardiac failure

Drug hypersensitivity

Gastritis

Dermatomyositis

Oesophagitis

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab, Pertuzumab, and Taxane

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~5370

Epirubicin

2012

Completed Phase 4

~19470