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Trastuzumab

Antineoplastic Agents, Immunological

Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.

Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.

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.

Trastuzumab Injectable Solution

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

Trastuzumab Injectable Product

Powder for concentrate for solution for infusion. 1 cycle

Trastuzumab Injection

Study Director

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.

Eligible patients, from the randomization and before starting subcutaneous trastuzumab (SC-t), received an additional intravenous (IV-t) cycle. After receiving this cycle, patients started the treatment with the study medication, SC-t at a fixed dose of 600 mg every 3 weeks (+3 days) for 4 cycles (2 administered from the injection of a vial in a syringe and 2 with the single-use injection device \[SID\]), being randomized 1:1 in two arms of treatment without washout period:

* Arm A (1 cycle of IV-t followed by 2 cycles of SC-t with vial followed by 2 cycles of SC-t with SID)
* Arm B (1 cycle of IV-t followed by 2 cycles of SC-t with SID followed by 2 cycles of SC-t with vial)

This is not a cross-over study.

Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer

Phase III Trial to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous (IV) Administration in HER2 Positive Advanced Breast Cancer Who Have Received IV Trastuzumab at Least 4 Months and Without Disease Progression

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.

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.

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.

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.

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.

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.

Spanish Breast Cancer Research Group

AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment.

AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.

Arm A: T-IV + T-SC Vial + T-SC Device

Arm B: T-IV + T-SC Device + T-SC Vial

Total

Age, Continuous

Sex: Female, Male

Caucasian

Black

Hispanic

Arabian

Race/Ethnicity, Customized

Menopausal status

Measure Description: ECOG score runs from 0 to 5, with 0 denoting perfect health and 5 death.

0 - Asymptomatic

1. - Symptomatic but completely ambulatory
2. - Symptomatic, \<50% in bed during the day
3. - Symptomatic, \>50% in bed, but not bedbound
4. - Bedbound
5. - Death

Eastern Cooperative Oncology Group (ECOG) performance status

A cancer is called hormonal receptor positive if it has receptors for progesterone or estrogen. This suggests that the cancer cells, like normal breast cells, may receive signals from progesterone or estrogen that could promote their growth.

If the cancer is hormone-receptor-negative (no receptors are present), then hormonal therapy is unlikely to work.

Estrogen Receptor

Progesterone Receptor

Time with IV trastuzumab for metastasis at registration

Treatment/s combined with IV-trastuzumab at registration

Other anti Human Epidermal growth factor Receptor 2 (HER-2) therapy at registration

Administration route at registration

Metastases 1 at diagnosis

Visceral metastases at registration

Bone metastases at registration

Skin/soft tissue/lymph nodes metastases at registration

The greater number of lines previously received by a patient, the worst prognosis.

Median of prior treatment lines at registration

1 Line

2 Lines

3 Lines

4 Lines

5 Lines

6 Lines

7 Lines

None Line

Prior treatment lines at registration

We do not have longterm follow-up data of the SC-t efficacy. Device SC-t SID has not been commercialized. All patients had already been treated with IV-t for at least 4 months without disease progression prior to the study entry.

Scientific Director / Medical Lead / Project Manager

Patients were randomized 1:1 in 2 arms:

Arm A: (1 cycle IV-t followed by 2 cycles SC-t with vial followed by 2 cycles SC-t with SID) Arm B: (1 cycle IV-t followed by 2 cycles SC-t with SID followed by 2 cycles SC-t with vial)

Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference

Patients were randomized 1:1 in 2 arms:

Arm A: (1 cycle IV-t followed by 2 cycles SC-t with vial followed by 2 cycles SC-t with SID) Arm B: (1 cycle IV-t followed by 2 cycles SC-t with SID followed by 2 cycles SC-t with vial) It has been analysed in patients from Intention To Treat (ITT) population which have completed questionnaire nº 3 (Arm A 72 patients and Arm B 80 patients).

Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference

Questionnaires were given to the health care professionals of both arms. There have been completed 39 health care professional satisfaction questionnaires. Information not provided by arm.

Both Arms

Questionnaires were given to the health care professionals of both arms. Information has been analyzed per administration type, not per arm.

39 health care professional satisfaction questionnaires were completed. Health care professionals were not considered enrolled, but did contribute to this assessment.

Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference

Percentage of Medical Staff Subcutaneous Device vs. Vial Preference

Healthcare unit

Sitting in the infusion/treatment chair/bed

Patients from both arms (A and B) who received Intravenous-Trastuzumab as per clinical practice.

Both Arms: Intravenous-Trastuzumab (IV-t)

Patients from both arms (A and B) who received Subcutaneous (SC) injection vial.

Both Arms: Subcutaneous-Trastuzumab Vial (SC-t Vial)

Patients from both arms (A and B) who received Single injection device

Boths Arms: Subcutaneous-Trastuzumab Device (SC-t SID)

This analysis was considered from 87 patients of the 166 patients included into the study, on who information of observed tasks were collected. 217 observations were made from these patients: 74 about IV-t administration process, 75 about SC-SID administration process, 68 about SC-Vial administration process.

Patient Time in Healthcare Unit and Sitting in Chair/Bed

Safety Population included all patients randomized in the study who received at least one dose of treatment, and they were analyzed according to the actual treatment received (81 patients in arm A and 85 patients in arm B).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer	NCT01875367	Breast Cancer	Trastuzumab Inj... Trastuzumab Inj... Trastuzumab Inj...	18 Years -	Spanish Breast Cancer Research Group
Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer	NCT01875367	Breast Cancer	Trastuzumab Inj... Trastuzumab Inj... Trastuzumab Inj...	18 Years -	Spanish Breast Cancer Research Group

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