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

NCT ID: NCT01875367

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-18
• Study Completion Date: 2018-04-30

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: T-IV + T-SC vial + T-SC device

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.

Group Type: EXPERIMENTAL

Trastuzumab Injectable Solution

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Powder for concentrate for solution for infusion. 1 cycle

Arm B: T-IV + T-SC device + T-SC vial

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.

Group Type: EXPERIMENTAL

Trastuzumab Injectable Solution

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Powder for concentrate for solution for infusion. 1 cycle

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Trastuzumab Injection

Powder for concentrate for solution for infusion. 1 cycle

Intervention Type: DRUG

Other Intervention Names

Herceptin; Herceptin; Herceptin

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Spanish Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Hospitales Universitarios Virgen del Rocío

Locations

Hospital de Manacor

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

Hospital Universitario San Joan de Reus

Reus, Tarragona, Spain

Hospital Nuestra Señora de Sonsoles

Ávila, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital Germans Trias i Pujol

Barcelona, , Spain

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, , Spain

Hospital Universitario Lucus Augusti

Lugo, , Spain

Hospital Universitario La Princesa

Madrid, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Virgen de la Macarena

Seville, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Virgen de la Salud

Toledo, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

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 evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07). Eur J Cancer Care (Engl). 2020 Jul;29(4):e13253. doi: 10.1111/ecc.13253. Epub 2020 Jun 23.

Reference Type: RESULT

PMID: 32578279 (View on PubMed)

Related Links

http://www.geicam.org

Sponsor's web

Other Identifiers

2012-004928-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GEICAM/2012-07

Identifier Type: -

Identifier Source: org_study_id