Clinical trial NCT01928615: A Study of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer
Official title: LISAH: An Open-label, Randomised Phase II Study Assessing Quality of Life Associated With Subcutaneous Trastuzumab Injected Into the Thigh or Upper Arm in Patients With HER2-positive Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Quality of Life Score
timeFrame: Cycles 7-14 (Weeks 19-42, 24 weeks total)
Secondary outcomes:
measure: Overall Survival
timeFrame: Baseline to the end of the study (up to 54 weeks)
measure: Disease-free Survival
timeFrame: Baseline to the end of the study (up to 54 weeks)
measure: Health Care Provider's Satisfaction With the Injection Site
timeFrame: End of Cycles 10 and 14 (Weeks 30 and 42)
measure: Participant's Satisfaction With the Injection Site
timeFrame: End of Cycles 10 and 14 (Weeks 30 and 42)
measure: Percentage of Participants Preferring Each Injection Site
timeFrame: End of Cycle 14 (Week 42)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Salzburg
country: Austria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: