Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer (HERA)

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Herceptin

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT00045032

ROCHE-B016348C

BO16348

IBCSG-28-02

CAN-NCIC-MA24

ROCHE-B016348E

EU-20216

BIG-01-01

EORTC-10011

Details and patient eligibility

About

The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

Enrollment: 5,099 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging
• Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable
• Known hormone receptor status
• Baseline left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55 percent (%)

Exclusion criteria

• Prior invasive breast carcinoma
• Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
• Clinical T4 tumors
• Cumulative doxorubicin exposure greater than (>) 360 milligrams per meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or any prior anthracyclines unrelated to the present breast cancer
• Peripheral stem cell or bone marrow stem cell support
• Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer
• Non-irradiated internal mammary nodes or supraclavicular lymph node involvement
• Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer
• Concurrent anti-cancer treatment in another investigational trial
• Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment
• Poor hematologic, hepatic, or renal function
• Pregnancy or lactation
• Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,099 participants in 3 patient groups

Observation Arm

No Intervention group

Description:

Participants who have completed definitive surgery and systemic adjuvant chemotherapy will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin will be provided.

Herceptin 1-Year Arm

Experimental group

Description:

Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 1 year or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.

Treatment:

Drug: Herceptin

Drug: Herceptin

Herceptin 2-Year Arm

Experimental group

Description:

Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 2 years or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.

Treatment:

Drug: Herceptin

Drug: Herceptin