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

NCT01928615 | Terminated Phase 2 Results

• 2 other identifiers: ML287862013-001023-39
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Overall Survival

  Baseline to the end of the study (up to 54 weeks)

• Disease-free Survival

  Baseline to the end of the study (up to 54 weeks)

• Health Care Provider's Satisfaction With the Injection Site

  End of Cycles 10 and 14 (Weeks 30 and 42)

• Participant's Satisfaction With the Injection Site

  End of Cycles 10 and 14 (Weeks 30 and 42)

• Percentage of Participants Preferring Each Injection Site

  End of Cycle 14 (Week 42)

Study Arms (2)

Trastuzumab - Thigh first, then upper arm

EXPERIMENTAL

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).

Drug: Trastuzumab - intravenous solution; Drug: Trastuzumab - subcutaneous solution; Drug: Chemotherapy

Trastuzumab - Upper arm first, then thigh

EXPERIMENTAL

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).

Drug: Trastuzumab - intravenous solution; Drug: Trastuzumab - subcutaneous solution; Drug: Chemotherapy

Interventions

Trastuzumab - intravenous solution DRUG

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

Also known as: Herceptin, Ro 45-2317

Trastuzumab - Thigh first, then upper arm; Trastuzumab - Upper arm first, then thigh

Trastuzumab - subcutaneous solution DRUG

Trastuzumab was supplied as a solution for subcutaneous injection.

Also known as: Herceptin, Ro 45-2317

Trastuzumab - Thigh first, then upper arm; Trastuzumab - Upper arm first, then thigh

Chemotherapy DRUG

Standard chemotherapy for early breast cancer.

Trastuzumab - Thigh first, then upper arm; Trastuzumab - Upper arm first, then thigh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 27, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 29, 2014
• Results First Posted: September 29, 2014

Record last verified: 2014-09

Locations

AU (2)