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

NCT01875367 | Completed Phase 3 Results

• 2 other identifiers: GEICAM/2012-072012-004928-38
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 27

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.

Conditions

Breast Cancer

Keywords

Subcutaneous trastuzumab; Intravenous trastuzumab; HER2 positive; Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Up to 12 weeks

• Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference

  Up to 12 weeks

• Percentage of Medical Staff Subcutaneous Device vs. Vial Preference

  Up to 12 weeks

• Patient Time in Healthcare Unit and Sitting in Chair/Bed

  An average of 4 months

• The Number of Participants Who Experienced Adverse Events (AE)

  Through study treatment, an average of 12 weeks

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Trastuzumab Injectable Solution; Drug: Trastuzumab Injectable Product; Drug: Trastuzumab Injection

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

EXPERIMENTAL

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.

Drug: Trastuzumab Injectable Solution; Drug: Trastuzumab Injectable Product; Drug: Trastuzumab Injection

Interventions

Trastuzumab Injectable Solution 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.

Also known as: Herceptin

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

Trastuzumab Injectable Product 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

Also known as: Herceptin

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

Trastuzumab Injection DRUG

Powder for concentrate for solution for infusion. 1 cycle

Also known as: Herceptin

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• immuno-histochemistry (IHC) 3+ (\>10% of tumor cells with complete and intense membrane staining)
• IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (\*)
• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead

Study Sites (27)

Hospital de Manacor

Manacor, Balearic Islands, 07500, Spain

Location

Hospital General Universitario de Granollers

Granollers, Barcelona, 08402, Spain

Location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Hospital Sant Joan Despí Moises Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location

Hospital Virgen del Puerto de Plasencia

Plasencia, Cáceres, 10600, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28924, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Univesitario Quirón Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

Location

Hospital Universitario San Joan de Reus

Reus, Tarragona, 43201, Spain

Location

Hospital Nuestra Señora de Sonsoles

Ávila, 05004, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27004, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28021, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related 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 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.

  PMID: 32578279 RESULT

Related Links

• Sponsor's web

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

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.

Results Point of Contact

• Title: Scientific Director / Medical Lead / Project Manager
• Organization: Spanish Breast Cancer Research Group

geicam@geicam.org

+34916592870

Study Officials

• Study Director

  Hospitales Universitarios Virgen del Rocío

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 11, 2013
• Study Start: September 18, 2013
• Primary Completion: November 30, 2016
• Study Completion: April 30, 2018
• Last Updated: April 5, 2023
• Results First Posted: February 1, 2021

Record last verified: 2023-04

Locations

ES (27)