A Phase III Clinical Trial to Evaluate Patient´s Preference of Subcutaneous Trastuzumab (SC) Versus Intravenous (IV) Administration in Patients With HER2 Positive Advanced Breast Cancer (ABC). (ChangHER-SC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Spanish Breast Cancer Research Group
Sponsor:
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT01875367
First received: June 7, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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. 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.


Condition Intervention Phase
Brest Cancer
Drug: Trastuzumab subcutaneous inyection vial
Device: Trastuzumab subcutaneous device administration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate Patient´s Preference of Subcutaneous Trastuzumab (SC) Versus Intravenous (IV) Administration in Patients With HER2 Positive Advanced Breast Cancer (ABC) Who Have Received Intravenous Trastuzumab at Least 4 Months and Without Disease Progression

Resource links provided by NLM:


Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • Percentage of treatment preference [ Time Frame: 6 months after the date on which the last patient receives the fourth cycle of study ] [ Designated as safety issue: No ]
    To analyze the percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab (will be analyzed with the answers to the questionnaire of experiences and preferences of the patient)


Secondary Outcome Measures:
  • Percentage of subcutaneous treatment (Vial v.s. device administration)preference [ Time Frame: 6 months after the date the last patient receives the fourth cycle of study treatment ] [ Designated as safety issue: No ]
    To analyze the percentage of patients who indicate a preference for the use of SC administration by road or device: will be discussed in the answers to question number 28 of the questionnaire of experiences and preferences of the patient.

  • Medical staff satisfaction [ Time Frame: 6 months after the date the last patient receives the fourth cycle of study treatment ] [ Designated as safety issue: No ]
    To analyze medical staff satisfaction with the use of different methods of treatment administration: will be discussed in the answers to question number 33 of thequestionnaire of experiences and preferences of the medical staff.

  • Time and progress study [ Time Frame: 6 months after the date the last patient receives the fourth SC Trastuzumab treatment cycle ] [ Designated as safety issue: No ]
    To analyze administration costs and indirect costs (by means of a time and progress study) of different treatment methods. This point is developed in the sub-study protocol.

  • Safety and tolerability of different treatment methods [ Time Frame: 6 months after the date the last patient receives the fourth SC Trastuzumab treatment cycle ] [ Designated as safety issue: Yes ]
    Analyze the safety and tolerability of different treatment methods will be studied and AAGS AAs. Also take into account all premature treatment dropout due to drug toxicities.

  • Immunogenicity of trastuzumab SC (vial and device) and intravenous. [ Time Frame: 6 months after the date the last patient receives the fourth cycle of study treatment ] [ Designated as safety issue: No ]
    To study the immunogenicity of trastuzumab SC (vial and device) and intravenous.


Estimated Enrollment: 160
Study Start Date: September 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab subcutaneous inyection vial
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
Drug: Trastuzumab subcutaneous inyection vial
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.
Device: Trastuzumab subcutaneous device administration
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
Experimental: Trastuzumab subcutaneous device administration
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
Drug: Trastuzumab subcutaneous inyection vial
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.
Device: Trastuzumab subcutaneous device administration
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman, 18 years old or upper.
  • Patient with advanced breast cancer with HER2 positive histologically confirmed. The criteria for positivity HER2 are: - IHC 3 + - IHQ2 + with FISH / CISH / SISH positive for HER2 amplification (*) - FISH / CISH / SISH positive for HER2 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 HER2-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 CHF, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875367

Contacts
Contact: Eva Carrasco Carrascal, MD + 34 916592870 ecarrasco@geicam.org
Contact: Yolanda Amigo Fernández, BD + 34 916592870 yamigo@geicam.org

Locations
Spain
Hospital Universitario Fundación Alcorcón Not yet recruiting
Alcorcón, Madrid, Spain, 28922
Contact: Carlos Jara Sánchez, MD         
Principal Investigator: Carlos Jara Sánchez, MD         
Hospital Universitario de Fuenlabrada Not yet recruiting
Fuenlabrada, Madrid, Spain, 28924
Contact: Diego Malón Giménez, MD         
Principal Investigator: Diego Malón Giménez, MD         
Hospital Universitario Santa Lucía Not yet recruiting
Cartagena, Murcia, Spain, 30202
Contact: Pablo Cerezuela Fuentes, MD         
Principal Investigator: Pablo Cerezuela Fuentes, MD         
Hospital del Mar Not yet recruiting
Barcelona, Spain, 08003
Contact: Laia Garrigós Cubells, MD         
Principal Investigator: Laia Garrigós Cubells, MD         
Hospital Germans Trias i Pujol Not yet recruiting
Barcelona, Spain, 08916
Contact: Vanesa Quiroga García, MD         
Principal Investigator: Vanesa Quiroga García, MD         
Hospital Universitario Puerta del Mar Recruiting
Cádiz, Spain, 11009
Contact: José M. Baena Cañada, MD         
Principal Investigator: José M. Baena Cañada, MD         
Hospital Universitario Arnau de Vilanova de Lleida Not yet recruiting
Lleida, Spain, 25198
Contact: Serafín Morales Murillo, MD         
Principal Investigator: Serafín Morales Murillo, MD         
Hospital Lucus Augusti Not yet recruiting
Lugo, Spain, 27004
Contact: Elena Álvarez Gómez, MD         
Principal Investigator: Elena Álvarez Gómez, MD         
Hospital General Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain, 28007
Contact: Miguel Martín Jiménez, MD, PhD         
Principal Investigator: Miguel Martín Jiménez, MD, PhD         
Hospital Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain, 41013
Contact: Ana Casas Fernández de Tejerina, MD         
Principal Investigator: Ana Casas Fernández de Tejerina, MD         
Hospital Universitario Virgen de la Macarena Not yet recruiting
Sevilla, Spain, 41009
Contact: Luis De la Cruz Merino, MD         
Principal Investigator: Luis De la Cruz Merino, MD         
Hospital Clínico Universitario de Valencia Not yet recruiting
Valencia, Spain, 46010
Contact: Ana Lluch Hernández, MD         
Principal Investigator: Ana Lluch Hernández, MD         
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Investigators
Study Director: Ana M. Casas Fernández de Tejerina, MD Hospitales Universitarios Virgen del Rocío
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT01875367     History of Changes
Other Study ID Numbers: GEICAM/2012-07
Study First Received: June 7, 2013
Last Updated: December 16, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Breast Cancer Research Group:
Subcutaneous trastuzumab
Intravenous trastuzumab
HER2 positive
Advanced Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014