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

Breast Cancer Clinical Trial

— LISAH  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01928615
• Other study ID #: ML28786
• Secondary ID: 2013-001023-39
• Status: Terminated
• Phase: Phase 2
• First received: August 21, 2013
• Last updated: September 25, 2014
• Start date: September 2013
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen (BASG)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab - intravenous solution
Trastuzumab was supplied as a powder to be reconstituted as a solution for intravenous infusion.
• Trastuzumab - subcutaneous solution
Trastuzumab was supplied as a solution for subcutaneous injection.
• Chemotherapy
Standard chemotherapy for early breast cancer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Score	Participants rated their quality of life on a visual analog scale (VAS) at the end of each cycle for Cycles 7-14. The left-end of the VAS represented the lowest-rated quality of life and the right-end of the VAS represented the highest-rated quality of life. Both the mean ratings for injections into the thigh and the upper arm and the minimum ratings for during injections into the thigh and the upper arm are reported. Quality of life scores ranged from 1 to 100 with a higher score indicating a better rated quality of life.	Cycles 7-14 (Weeks 19-42, 24 weeks total)	No
Secondary	Overall Survival	Overall survival was defined as the time in months from Baseline to death from any cause.	Baseline to the end of the study (up to 54 weeks)	No
Secondary	Disease-free Survival	Disease-free survival was defined as the time in months from Baseline to disease recurrence or death, whichever occurred first.	Baseline to the end of the study (up to 54 weeks)	No
Secondary	Health Care Provider's Satisfaction With the Injection Site	The health care provider for each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.	End of Cycles 10 and 14 (Weeks 30 and 42)	No
Secondary	Participant's Satisfaction With the Injection Site	Each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.	End of Cycles 10 and 14 (Weeks 30 and 42)	No
Secondary	Percentage of Participants Preferring Each Injection Site	Participants were asked which of the 2 injection sites was their preferred site at the end of Cycle 14.	End of Cycle 14 (Week 42)	No