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.
Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a syringe and 2 with the injection device). Following administration of these four cycles, the patient will decide whether or not to continue with the subcutaneous formulation of trastuzumab every 3 weeks until progression (out of the study). Since the randomization in the study until the start with subcutaneous trastuzumab, patients will receive a treatment cycle of intravenous trastuzumab as usual. Main objective: Proportion of patients indicate a preference for the use of subcutaneous vs intravenous trastuzumab. This principal primary objective will be analyzed with the answers to questionnaire of experiences and preferences of the patients (Principal endpoint) The duration of the study has been estimated after 34 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Subcutaneous injection vial with a fixed dose of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) identical to that provided by the device. 3 weeks x 2 cycles.
Single injection device is provided and loaded with the mixture of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) and is ready for use. 3 weeks x 2 cycles
Powder for concentrate for solution for infusion. 1 cycle
Hospital de Manacor
Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference
The percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab was analyzed with the answer to the questionnaire C2, question number 39 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of experiences and preferences of the patient.
Time frame: Up to 12 weeks
Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference
The percentage of patients who indicate a preference for the use of SC administration by vial or device was analyzed. This was discussed in the answer to questionaire C3, question number 28 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of the questionnaire of experiences and preferences of the patient.
Time frame: Up to 12 weeks
Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference
The medical staff satisfaction was analyzed with the answers to question number 33a (Considering all aspects, with what method of administration were you more satisfied? Between Intravenous vs. Subcutaneous: Intravenous; Subcutaneous; No differences) of the questionnaire of experiences and preferences of the medical staff. Health care professionals were not considered enrolled, but did contribute to this assessment.
Time frame: Up to 12 weeks
Percentage of Medical Staff Subcutaneous Device vs. Vial Preference
The medical staff satisfaction was analyzed with the answers to question number 33b (Considering all aspects, with what method of administration were you more satisfied? Between Vial vs. Device: Preferred device; Preferred vial; No Preference) of the questionnaire of experiences and preferences of the medical staff. Health care professionals were not considered enrolled, but did contribute to this assessment.
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Manacor, Balearic Islands, Spain
Hospital General Universitario de Granollers
Granollers, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Sant Joan Despí Moises Broggi
Sant Joan Despí, Barcelona, Spain
Hospital Virgen del Puerto de Plasencia
Plasencia, Cáceres, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Univesitario Quirón Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Santa Lucía
Cartagena, Murcia, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
...and 17 more locations
Time frame: Up to 12 weeks
Patient Time in Healthcare Unit and Sitting in Chair/Bed
Time spent by patient in the healthcare unit: Time between entrance and exit from the healthcare unit. Time spent by patient sitting in the infusion/treatment chair/bed: Time between sitting and rising from the patient treatment chair/bed The data was collected by qualified observers from site staff that measured the time spent by healthcare professional using a chronometer, and write it down in the paper questionnaires or directly or after in the electronic case report form.
Time frame: An average of 4 months
The Number of Participants Who Experienced Adverse Events (AE)
Safety was assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 4.03.
Time frame: Through study treatment, an average of 12 weeks