Study of Neoadjuvant Myocet®, Paclitaxel, Pertuzumab, and Trastuzumab in HER2-positive Breast Cancer (Opti-HER)

October 31, 2017 updated by: SOLTI Breast Cancer Research Group

OptiHER-Heart: A Prospective, Multicenter, Single-arm, Phase II Study to Evaluate the Safety of Neoadjuvant Liposomal Doxorubicin (Myocet®) Plus Paclitaxel, Trastuzumab, and Pertuzumab in Patients With HER2-positive Breast Cancer

This is a prospective, multicenter, single-arm, phase II study to evaluate the safety of neoadjuvant liposomal doxorubicin plus paclitaxel, trastuzumab, and pertuzumab in patients with HER2-positive breast cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Hospital Universitario Vall d´Hebron
      • Cáceres, Spain
        • Complejo Hospitalario San Pedro de Alcántara
      • Lleida, Spain
        • Hospital Universitari Arnau de Vilanova de Lleida
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Centro Integral Oncologico Clara Campal
      • Madrid, Spain
        • Hospital Universitario Clínico San Carlos
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro de Majadahonda
      • Madrid, Spain
        • MD Anderson Cancer Center Madrid
      • Murcia, Spain
        • Hospital Universitario Virgen de La Arrixaca
      • Palma de Mallorca, Spain
        • Hospital Son Llàtzer
      • Palma de Mallorca, Spain
        • Hospital Universitari Son Espases
      • Reus, Spain
        • Hospital Sant Joan de Reus
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain
        • Hospital Sagrado Corazón USP
      • Sevilla, Spain
        • Hospital Virgen de la Macarena
      • Valencia, Spain
        • Fundación Instituto Valenciano de Oncología
      • Valencia, Spain
        • Hospital Arnau de Vilanova de Valencia
      • Zaragoza, Spain
        • Hospital Universitario Lozano Blesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures
  • Female patients
  • Age 18-74 years
  • ECOG Performance Status of 0 or 1
  • Histologically confirmed, untreated, invasive breast carcinoma stage II-IIIB
  • Tumor size > 2 cm by clinical or radiological assessment
  • HER2+ invasive BC according to ASCO/CAP guidelines
  • Known hormone receptor status or the possibility of its assessment

  • Adequate organ function defined as:

    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 10**9/L
    • Hemoglobin (Hgb) ≥ 9 g/dL
    • Platelets > 100 x 10**9/L
    • Creatinine ≤ 1.6 mg/dL
    • ALT and AST ≤ 2.5 x ULN
    • Alkaline phosphatase ≤ 5 ULN
    • Total bilirubin ≤ 1.5 mg/dL
  • Baseline LVEF ≥ 55% measured by echocardiogram or MUGA scan
  • Negative β-HCG pregnancy test (serum) for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after the menopause. All subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from 2 weeks before administration of the first dose of investigational product until 28 days after the last dose of investigational product
  • Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Exclusion Criteria:

  • Clinical or radiologic evidence of metastatic disease at the time of study entry
  • Prior chemotherapy, radiotherapy, or surgery for BC, other than excision of a tumor in the contralateral breast, and provided that the patient did not previously receive adjuvant radiotherapy or chemotherapy
  • Subjects with a concurrently active second malignancy, other than adequately treated non melanoma skin cancers, in situ melanoma or in situ cervical cancer. Subjects with other non-mammary malignancies must have been disease-free for at least 5 years
  • Known or suspected hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances
  • Presence of CHF or LVEF < 55%
  • Clinically significant (i.e. active) cardiovascular disease, including cerebrovascular accident (< 6 months before enrollment), unstable angina pectoris, myocardial infarction ≤ 6 months before enrollment, uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg), or high-risk uncontrolled arrhythmias
  • Uncontrolled diabetes mellitus, active peptic ulcer disease, or uncontrolled epilepsy
  • Active uncontrolled infection at the time of enrolment
  • History of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent
  • Use of any investigational agent or participation in another therapeutic clinical trial concurrently or in the previous 30 days before the enrollment
  • Patients who are pregnant or breast-feeding
  • Women of child-bearing potential who are unable or unwilling to use acceptable contraceptive measures
  • Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Liposomal Doxorubicin

Six cycles of:

  • Trastuzumab 4 mg/kg loading dose on Day 1 of the first cycle, then 2 mg/kg on Days 8 and 15 of the first cycle and on Days 1, 8, and 15 of the subsequent cycles, every 3 weeks
  • Pertuzumab 840 mg loading dose on Day 1 of the first cycle, then 420 mg on Day 1, every 3 weeks
  • Liposomal doxorubicin 50 mg/m2 on Day 1, every 3 weeks
  • Paclitaxel 80 mg/m2 on Days 1, 8, and 15, every 3 weeks
Drug: Liposomal Doxorubicin

Six cycles of:

  • Trastuzumab 4 mg/kg loading dose on Day 1 of the first cycle, then 2 mg/kg on Days 8 and 15 of the first cycle and on Days 1, 8, and 15 of the subsequent cycles, every 3 weeks
  • Pertuzumab 840 mg loading dose on Day 1 of the first cycle, then 420 mg on Day 1, every 3 weeks
  • Liposomal doxorubicin 50 mg/m2 on Day 1, every 3 weeks
  • Paclitaxel 80 mg/m2 on Days 1, 8, and 15, every 3 weeks
Other Names:
  • Myocet® (liposome-encapsulated doxorubicin)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of symptomatic (type A) and asymptomatic (type B) cardiac events during the study treatment period
Time Frame: Following 12 months after first dose of the study treatment
Following 12 months after first dose of the study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
pCR in breast (pCRB)
Time Frame: At the time of definitive surgery, an expected average of 23 weeks
At the time of definitive surgery, an expected average of 23 weeks
pCR in breast and axilla (pCRBA)
Time Frame: At the time of definitive surgery, an expected average of 23 weeks
At the time of definitive surgery, an expected average of 23 weeks
Clinical objective response rate (cORR) in the breast and axilla by RECIST criteria version 1.1
Time Frame: At the time of definitive surgery, an expected average of 23 weeks
At the time of definitive surgery, an expected average of 23 weeks
Residual Cancer Burden (RCB) at surgery following the procedures of the MD Anderson Cancer Center
Time Frame: At the time of definitive surgery, an expected average of 23 weeks
At the time of definitive surgery, an expected average of 23 weeks
Breast conservation rate at surgery
Time Frame: At the time of definitive surgery, an expected average of 23 weeks
At the time of definitive surgery, an expected average of 23 weeks
Evaluation of serum biomarkers predictive of cardiotoxicity
Time Frame: Following 12 months after first dose of the study treatment
Following 12 months after first dose of the study treatment
Percentage of patients with grade 3/4 neutropenia (assessed by CTCAE v.4)
Time Frame: Following 12 months after first dose of the study treatment
Following 12 months after first dose of the study treatment
Time of onset and time of recovery from symptomatic (type A) and asymptomatic (type B) cardiac events (assessed by CTCAE v.4)
Time Frame: Following 12 months after first dose of the study treatment
Following 12 months after first dose of the study treatment
Dose reductions due to treatment toxicity (assessed by CTCAE v.4)
Time Frame: Following 12 months after first dose of the study treatment
Following 12 months after first dose of the study treatment
Dose delays due to treatment toxicity (assessed by CTCAE v.4)
Time Frame: Following 12 months after first dose of the study treatment
Following 12 months after first dose of the study treatment
Number of patients with adverse events and serious adverse events (assessed by CTCAE v.4)
Time Frame: Following 12 months after first dose of the study treatment
Following 12 months after first dose of the study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SOLTI Breast Cancer Research Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joaquín Gavilá Gregori, MD, Fundación Instituto Valenciano de Oncología

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOLTI-1002
  • 2012-001201-24 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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