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

Breast Cancer Clinical Trial

— ChangHER-SC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875367
• Other study ID #: GEICAM/2012-07
• Secondary ID: 2012-004928-38
• Status: Completed
• Phase: Phase 3
• Start date: September 18, 2013
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2023
• Source: Spanish Breast Cancer Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: April 30, 2018
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

1. immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining)

2. IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*)

3. 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) <2.

• Adequate bone marrow function, liver and kidney

• Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).

• The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.

• The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.

Exclusion Criteria:

• Patients with no advanced breast cancer.

• Breast cancer patients with tumors HER 2-negative.

• The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab Injectable Solution
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 Product
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 Injection
Powder for concentrate for solution for infusion. 1 cycle

Locations

Country	Name	City	State
Spain	Hospital Nuestra Señora de Sonsoles	Ávila
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital Universitario Santa Lucía	Cartagena	Murcia
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital General Universitario de Granollers	Granollers	Barcelona
Spain	Hospital Universitario Severo Ochoa	Leganés	Madrid
Spain	Hospital Universitario Arnau de Vilanova de Lleida	Lleida
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital de Manacor	Manacor	Illes Balears
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital de Mataró	Mataró	Barcelona
Spain	Hospital Virgen del Puerto de Plasencia	Plasencia	Cáceres
Spain	Hospital Univesitario Quirón Madrid	Pozuelo De Alarcón	Madrid
Spain	Hospital Universitario San Joan de Reus	Reus	Tarragona
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Sant Joan Despí Moises Broggi	Sant Joan Despí	Barcelona
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Breast Cancer Research Group

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Ciruelos EM, Montano A, Rodriguez CA, Gonzalez-Flores E, Lluch A, Garrigos L, Quiroga V, Anton A, Malon D, Chacon JI, Velasco M, Gonzalez-Cortijo L, Jolis L, Echarri MJ, Munoz M, Pascual T, Amigo Y, Casas M, Carrasco E, Casas A. Phase III study to evaluat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 weeks
Secondary	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.	Up to 12 weeks
Secondary	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.	Up to 12 weeks
Secondary	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.	Up to 12 weeks
Secondary	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.	An average of 4 months
Secondary	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.	Through study treatment, an average of 12 weeks

External Links

•   Sponsor's web