A Study of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer

NCT ID: NCT01928615

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-10-31

Brief Summary

This open-label, randomized crossover study evaluated the quality of life, efficacy, and safety of subcutaneous Herceptin (trastuzumab) injected either into the thigh or the upper arm of participants with early HER2-positive breast cancer.

Detailed Description

In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Participants could also receive a maximum of 6 cycles of standard chemotherapy for early breast cancer (neo-adjuvant or adjuvant) in the run-in phase.

Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). For Cycles 15-18, participants could choose the injection site for trastuzumab 600 mg subcutaneously every 3 weeks.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab - Thigh first, then upper arm

In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Participants could also receive a maximum of 6 cycles of standard chemotherapy for early breast cancer (neo-adjuvant or adjuvant) in the run-in phase. Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).

Group Type: EXPERIMENTAL

Trastuzumab - intravenous solution

Intervention Type: DRUG

Trastuzumab was supplied as a powder to be reconstituted as a solution for intravenous infusion.

Trastuzumab - subcutaneous solution

Intervention Type: DRUG

Trastuzumab was supplied as a solution for subcutaneous injection.

Chemotherapy

Intervention Type: DRUG

Standard chemotherapy for early breast cancer.

Trastuzumab - Upper arm first, then thigh

In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Participants could also receive a maximum of 6 cycles of standard chemotherapy for early breast cancer (neo-adjuvant or adjuvant) in the run-in phase. Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).

Group Type: EXPERIMENTAL

Trastuzumab - intravenous solution

Intervention Type: DRUG

Trastuzumab was supplied as a powder to be reconstituted as a solution for intravenous infusion.

Trastuzumab - subcutaneous solution

Intervention Type: DRUG

Trastuzumab was supplied as a solution for subcutaneous injection.

Chemotherapy

Intervention Type: DRUG

Standard chemotherapy for early breast cancer.

Interventions

Trastuzumab - intravenous solution

Trastuzumab was supplied as a powder to be reconstituted as a solution for intravenous infusion.

Intervention Type: DRUG

Trastuzumab - subcutaneous solution

Trastuzumab was supplied as a solution for subcutaneous injection.

Intervention Type: DRUG

Chemotherapy

Standard chemotherapy for early breast cancer.

Intervention Type: DRUG

Other Intervention Names

Herceptin; Ro 45-2317; Herceptin; Ro 45-2317

Eligibility Criteria

Inclusion Criteria

• Female and male patients ≥ years of age.
• HER2-positive early breast cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Hormonal therapy will be allowed as per institutional guidelines.
• Patients must be Herceptin (trastuzumab) naïve.
• Left ventricular ejection fraction (LVEF) of ≥ 55%.
• Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast.
• No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant).
• Use of concurrent curative radiotherapy will be permitted.

Exclusion Criteria

• History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible.
• Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.
• Patients with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness.
• Serious cardiac illness or medical conditions that would preclude the use of Herceptin, specifically, a history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), or diagnosed poorly controlled hypertension.
• Pregnant or lactating women.
• Women of childbearing potential and male patients with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment.
• Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy, and immunotherapy, within 28 days prior to the first dose of study treatment.
• Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or a history of severe allergic or immunological reactions, eg, difficult to control asthma.
• Inadequate bone marrow, hepatic, or renal function.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Innsbruck, , Austria

Salzburg, , Austria

Countries

Austria

Other Identifiers

2013-001023-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28786

Identifier Type: -

Identifier Source: org_study_id