Phase 3
Completed N=2,577
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
Source: ClinicalTrials.gov NCT01566721 ↗Enrolled (actual)
2,577
Serious AEs
11.3%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period — 88.6; 89.0 percentage of participants
◆ Published Evidence
Established
46citations · ~5 / year
Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients.
Summary
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).
Linked Publications (2)
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Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients.
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Adjuvant Subcutaneous Trastuzumab for HER2-Positive Early Breast Cancer: Subgroup Analyses of Safety and Active Medical Conditions by Body Weight in the SafeHer Phase III Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period |
88.6; 89.0 | — |
| PRIMARY Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period |
24.0; 21.0 | — |
| PRIMARY Percentage of Participants With Treatment Interruption Due to an AE |
9.8; 10.4 | — |
| PRIMARY Number of Herceptin Cycles Received |
16.0; 18.0; 18.0 | — |
| PRIMARY Percentage of Participants by Total Number of Herceptin Cycles Received |
2.7; 1.0; 0.8; 1.3; 0.5; 0.4 | — |
| PRIMARY Percentage of Participants Who Received Concomitant Cancer Therapy |
58.2; 63.9; 51.3; 48.5; 53.5; 50.4 | — |
| PRIMARY Percentage of Participants Who Received Concomitant Non-Cancer Therapy |
89.1; 89.7 | — |
| SECONDARY Percentage of Participants Who Died by Data Cutoff of 10 March 2015 |
1.5; 0.8 | — |
| SECONDARY Percentage of Participants Who Died During the Safety Follow-up Period |
6.8; 7.3 | — |
| SECONDARY Disease-Free Survival Rate |
0.990; 0.987; 0.975; 0.976; 0.960; 0.957 | — |
| SECONDARY Overall Survival Rate |
0.999; 0.996; 0.998; 0.994; 0.993; 0.990 | — |
| SECONDARY Percentage of Participants by Item Response to SID Satisfaction Questionnaire |
4.7; 2.3; 7.6; 41.6; 43.6; 0.2 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%
Exclusion Criteria
- Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
- History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
- Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
- Metastatic disease
- Inadequate bone marrow, hepatic, or renal function
- Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- History of severe allergic or immunological reactions, such as difficult-to-control asthma
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT01566721) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.