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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • 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 Alcantara
      • 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 Clinico 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 Llatzer
      • Palma de Mallorca, Spain
        • Hospital Universitari Son Espases
      • Reus, Spain
        • Hospital Sant Joan de Reus
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocío
      • Sevilla, Spain
        • Hospital Sagrado Corazón USP
      • Sevilla, Spain
        • Hospital Virgen de la Macarena
      • Valencia, Spain
        • Fundacion Instituto Valenciano de Oncologia
      • 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

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
Intervention / Treatment
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

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

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

SOLTI Breast Cancer Research Group

Investigators

  • Principal Investigator: Joaquín Gavilá Gregori, MD, Fundacion Instituto Valenciano de Oncologia

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

June 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 9, 2012

First Submitted That Met QC Criteria

August 17, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Breast Cancer

Clinical Trials on Liposomal Doxorubicin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe