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Opti-HER 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 Operable HER2-positive Breast Cancer

Phase 2
18 Years
74 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

Opti-HER 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 Operable HER2-positive Breast Cancer

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 eligible for primary
definitive surgery

- Tumor size 2 cm by clinical or radiological assessment

- HER2+ invasive BC, defined as: IHC 3+ in > 10% immunoreactive cells or HER2
geneamplification by in situ hybridization (FISH, CISH), defined as ratio of HER2
gene signals to centromere 17 ≥ 2.0

- 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 SOLTI 1002 Version
number: 1.0 17-02-2012

- 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

Exclusion Criteria:

- Clinical or radiologic evidence of metastatic disease at the time of study entry

- Stage III inoperable BC

- 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
cerebro-vascular 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

- 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 SOLTI 1002
Version number: 1.0 17-02-2012

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of symptomatic (type A) and asymptomatic (type B) cardiac events during the study treatment period

Outcome Time Frame:

Following 12 months after first dose of the study treatment

Safety Issue:


Principal Investigator

Joaquín Gavilá Gregori, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fundación Instituto Valenciano de Oncología


Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:




Start Date:

November 2012

Completion Date:

May 2015

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Lipossomal doxorubicin
  • Neoadjuvant
  • Paclitaxel
  • Trastuzumab
  • Pertuzumab
  • Safety
  • Breast Neoplasms
  • Neoplasms