Pertuzumab + Chemotherapy + Trastuzumab for Breast Cancer (APHINITY Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

Stay on your current meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

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.

Inclusion Criteria

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

My cancer is HER2 positive.

I agree to use effective birth control during and for 7 months after the study.

My breast cancer is HER2-positive, hasn't spread, and was surgically removed.

Exclusion Criteria

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

My cancer has not spread to the lymph nodes.

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.

I have a serious heart or blood vessel condition.

Treatment Details

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.

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 \[mg\]).

5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as 5-FU for: