Phase 3
Completed N=166
Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer
Source: ClinicalTrials.gov NCT01875367 ↗Enrolled (actual)
166
Serious AEs
7.2%
Results posted
Feb 2021
Primary outcomePrimary: Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference — 66; 71; 6; 5 Participants
◆ Published Evidence
Emerging
10citations · ~2 / year
Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07).
Summary
GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of trastuzumab, and within the SC by the administration through the vial or device self-administration in patients with disseminated breast cancer HER2.
Linked Publications
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Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference |
66; 71; 6; 5; 4; 7 | — |
| SECONDARY Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference |
46; 44; 20; 20; 4; 13 | — |
| SECONDARY Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference |
34; 0; 4; 1 | — |
| SECONDARY Percentage of Medical Staff Subcutaneous Device vs. Vial Preference |
20; 11; 8 | — |
| SECONDARY Patient Time in Healthcare Unit and Sitting in Chair/Bed |
203; 144.84; 122.9; 100.01; 31.6; 24.75 | — |
| SECONDARY The Number of Participants Who Experienced Adverse Events (AE) |
76; 84 | — |
Eligibility Criteria
Inclusion Criteria
- Woman, 18 years old or upper.
- Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:
- immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining)
- IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*)
- FISH / CISH / SISH + for HER 2 amplification (*) (*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER 2/neu> 6, as per local laboratory criteria.
- Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.
- No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.
- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 5 years without evidence of disease could be included.
- The patient has uncontrolled brain metastases.
- Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.
- Known hypersensitivity to trastuzumab or to any of its components.
- Patients with severe dyspnea at rest or requiring supplemental oxygen.
- Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.
- Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).
- The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.
Data sourced from ClinicalTrials.gov (NCT01875367) 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.