Revisions for A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer | Registro Público Cubano de Ensayos Clínicos

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A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

A RANDOMIZED, MULTICENTER, OPEN-LABEL CROSS-OVER STUDY TO EVALUATE PATIENT PREFERENCE AND SATISFACTION OF SUBCUTANEOUS ADMINISTRATION OF THE FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER

Secondary indentifying numbers:

MO40628

NCT03674112

Issuing authority of the secondary identifying numbers:

Roche Servicios S.A.

ClinicalTrials.gov

Source(s) of monetary or material support:

Primary Sponsor - Roche Servicios S.A.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

26/06/2019

Reference number:

708/05.004.19.NV

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jorge

Midle name:

Luis

Last name:

Soriano Garcia

Medical Specialty :

Medical Doctor, Second degree specialist in oncology

Affiliation:

Surgical-Clinic hospital "Hermanos Ameijeiras" (HHA)

Postal address:

San Lazaro No. 701 corner to Belascoain.

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761926

Email address:

onco@hha.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

United States of America

Argentina

Brazil

Chile

Finland

Mexico

Portugal

Spain

Sweeden

Panama

Cuba

Clinical sites:

Havana, National Institute of Oncology and Radiobiology (INOR), Dr. Elías Gracia Medina, Medical Doctor, First degree specialist in oncology

Research ethics committees:

Surgical-Clinic hospital "Hermanos Ameijeiras" (HHA), in review

National Institute of Oncology and Radiobiology (INOR), in review

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

20/09/2019

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

HER2-Positive Early Breast Cancer

Health condition(s) code:

Breast Neoplasms

Breast Diseases

Skin Diseases

Skin and Connective Tissue Diseases

Intervention(s):

Group A Experimental: Pertuzumab and Trastuzumab – intravenous (IV) followed by Fixed-Dose Combination (FDC) subcutaneously (SC). The participants will receive Pertuzumab IV and Trastuzumab IV for 3 treatment cycles followed by Pertuzumab and Trastuzumab FDC SC for 3 treatment cycles (1 cycle = 21 days). Group B Experimental: Pertuzumab and Trastuzumab - Fixed-Dose Combination (FDC) subcutaneously (SC) followed by intravenous route. The participants will receive Pertuzumab and Trastuzumab FDC SC for 3 treatment cycles followed by Pertuzumab IV and Trastuzumab IV for 3 treatment cycles (1 cycle = 21 days). Pertuzumab and Trastuzumab FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg Pertuzumab and 600 mg Trastuzumab is then followed by a maintenance dose of 600 mg Pertuzumab and 600 mg Trastuzumab once every 3 weeks. Pertuzumab will be administered intravenously (IV) as a fixed non-weight-based dose of 840 mg loading dose and then 420 mg maintenance dose once every 3 weeks. Trastuzumab will be administered intravenously (IV) as an 8 mg/kg IV loading dose and then 6 mg/kg as maintenance dose once every 3 weeks. Following completion of the study period, participants will choose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).

Intervention code:

Trastuzumab

Injections, Subcutaneous

Administration, Intravenous

Intervention keyword:

Pertuzumab

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Percentage of Participants Who Indicated They Preferred the Pertuzumab and Trastuzumab Fixed-Dose Combination Subcutaneous (FDC SC) Administration as Assessed in Question 1 of the Patient Preference Questionnaire [Time Frame: Cycle 6 Day 1 (each cycle is 21 days)]

Key secondary outcomes:

Participant-Assessed Satisfaction with Pertuzumab and Trastuzumab FDC SC, Based on Responses to Question 1 of the Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) [ Time Frame: Cycle 3 Day 1, Cycle 6 Day 1 (each cycle is 21 days) ] Participant-Assessed Satisfaction with Pertuzumab and Trastuzumab IV, Based on Responses to Question 1 of the Therapy Administration Satisfaction Questionnaire - Intravenous (TASQ-IV) [ Time Frame: Cycle 3 Day 1, Cycle 6 Day 1 (each cycle is 21 days) ] Percentage of Participants Who Select Pertuzumab and Trastuzumab FDC SC for the Study Treatment Continuation Period [ Time Frame: Cycle 7 Day 1 (each cycle is 21 days) ] Healthcare Professional (HCP) Perception of Time/Resource Use and Convenience of Each Study Regimen, Based on HCP Responses to the Healthcare Professional Questionnaire (HCPQ) - Treatment Room, by Individual Question [ Time Frame: Day 1 of Cycles 1-6 (each cycle is 21 days) ] Healthcare Professional (HCP) Perception of Time/Resource Use and Convenience of Each Study Regimen, Based on HCP Responses to the HCPQ - Drug Preparation Room, by Individual Question [ Time Frame: Day 1 of Cycles 1-6 (each cycle is 21 days) ] Change From Baseline Over Time in Health-Related Quality of Life (HRQoL) as Assessed by the Global Health Status/QoL Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Physical Functioning Scale Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Role Functioning Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Emotional Functioning Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Cognitive Functioning Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Social Functioning Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Fatigue Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Nausea and Vomiting Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Pain Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Dyspnoea Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Insomnia Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Appetite Loss Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Constipation Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Diarrhoea Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Change From Baseline Over Time in the Financial Difficulties Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ] Percentage of Participants with at Least One Adverse Event [ Time Frame: Up to 3 years ] Percentage of Participants with at Least One Grade ≥3 Adverse Event, Severity Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) [ Time Frame: Up to 3 years ] Percentage of Participants with Heart Failure [ Time Frame: Up to 3 years ] Heart failure severity will be assessed by the New York Heart Association (NYHA) Classification System For Heart Failure and the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0). Percentage of Participants with Left Ventricular Ejection Fraction (LVEF) Decreases of At Least 10 Percentage Points From Baseline and to Below 50% [ Time Frame: Baseline; Day 1 of Cycles 4, 7, and 11 (each cycle is 21 days); End of Treatment and Follow-Up visits (up to 3 years) ] Percentage of Participants who Withdraw Prematurely from Study Treatment [ Time Frame: Up to 1 year ] Percentage of Participants with an Adverse Event of Abnormal Targeted Vital Signs [ Time Frame: Up to 3 years ] Percentage of Participants with an Adverse Event of Abnormal Physical Examination Findings [ Time Frame: Up to 3 years ] Percentage of Participants with an Adverse Event of Abnormal Targeted Clinical Laboratory Test Results [ Time Frame: Up to 3 years ] Kaplan-Meier Estimate of the Percentage of Participants in Invasive Disease-Free Survival [ Time Frame: Up to 3 years ] Kaplan-Meier Estimate of the Percentage of Participants in Invasive Disease-Free Survival Including Second Primary Non-Breast Cancer [ Time Frame: Up to 3 years ] Kaplan-Meier Estimate of the Percentage of Participants in Distant Disease-Free Survival [ Time Frame: Up to 3 years ] Kaplan-Meier Estimate of the Percentage of Participants in Overall Survival [ Time Frame: Up to 3 years ]

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

Disease-specific criteria: Female or male with histologically confirmed, HER2-positive (HER2+) inflammatory, locally advanced or early-stage breast cancer who have received neoadjuvant pertuzumab and trastuzumab and have completed neoadjuvant chemotherapy and subsequently undergone surgery for their breast cancer. HER2+ breast cancer assessed at the local laboratory prior to initiation of neoadjuvant therapy. HER2+ status must be determined based on breast biopsy material obtained prior to neoadjuvant treatment and is defined as 3+ by immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥2 for the number of HER2 gene copies to the number of chromosome 17 copies. Hormone receptor status of the primary tumour determined by local assessment. Hormone receptor status may be either positive or negative. Completed all neoadjuvant chemotherapy and surgery. Adjuvant radiotherapy may be planned or ongoing at study entry and adjuvant hormone therapy is allowed during the study. Note that study treatment cannot be initiated within <2 weeks of surgery but must be initiated ≤9 weeks from the last administration of systemic neoadjuvant therapy. No evidence of residual, locally recurrent or metastatic disease after completion of surgery. Patients with clinical suspicion of metastases must undergo radiological assessments per institutional practice to rule out distant disease. Wound healing after breast cancer surgery adequate per investigator's assessment to allow initiation of study treatment within ≤9 weeks of last systemic neoadjuvant therapy. No adjuvant chemotherapy planned. Note that adjuvant hormonal treatment is allowed during the study. General criteria: Ability to comply with the study protocol, in the investigator's judgment. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Intact skin at planned site of subcutaneous injections (thigh). Left ventricular ejection fraction (LVEF) ≥55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan within 28 days of study randomization. No major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment. For women of childbearing potential: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating eggs, Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of <1% per year, or two effective non-hormonal contraceptive methods during the study treatment periods and for 7 months after the last dose of study treatment. For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, men must remain abstinent or use a condom during the study treatment periods and for seven months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period. A negative serum pregnancy test must be available prior to randomization for women of childbearing potential.

Exclusion criteria:

Cancer-specific criteria: Stage IV (metastatic) breast cancer. Current or prior history of active malignancy within the last five years. Appropriately treated non-melanoma skin cancer; in situ carcinomas, including cervix, colon, or skin; or Stage I uterine cancer within the last five years are allowed. Previous systemic therapy for treatment or prevention of breast cancer, except neoadjuvant Perjeta, Herceptin and chemotherapy for current breast cancer. General criteria: Investigational treatment within four weeks of enrolment. Serious cardiac illness or medical conditions. History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome. Inadequate bone marrow, renal and impaired liver function. Current severe, uncontrolled systemic disease that may interfere with planned treatment. Pregnant or breastfeeding, or intending to become pregnant during the study or within seven months after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within seven days prior to initiation of study treatment. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in, and completion of, the study. Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis. Concurrent, serious, uncontrolled infections, or known infection with human immunodeficiency virus (HIV). Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins. Current chronic daily treatment with corticosteroids.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Crossover

Phase:

2

Target sample size:

140 overall, 4 in Cuba

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

María

Middle Name:

Fernanda

Last Name:

Manavella

Specialty:

Nutritionist

Affiliation:

Roche Servicios S.A

Postal Address:

Ultrapark Free Zone, Building 4.

City:

La Aurora de Heredia

Country:

Costa Rica

Zip Code:

3438-1000

Telephone:

+506 2298-1000

Email :

maria_fernanda.manavella@roche.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

María

Middle Name:

Fernanda

Last Name:

Manavella

Specialty:

Nutritionist

Affiliation:

Roche Servicios S.A

Postal Address:

Ultrapark, Building 4

City:

La Aurora de Heredia

Country:

Costa Rica

Zip Code:

3438-1000

Telephone:

+506 2298-1000

Email :

maria_fernanda.manavella@roche.com

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

160 worldwide, 0 in Cuba

Study completion date:

02/10/2019

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000299

Date of Registration in Primary Registry:

12/03/2019

Record Verification Date:

2026/01/11

Next update date:

2027/01/11

Link to the spanish version:

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Registered Trials

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A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

About the RPCEC

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