NCT01669239

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.6 years

First QC Date

August 9, 2012

Last Update Submit

October 31, 2017

Conditions

Breast Cancer

Keywords

Breast CancerHER2 positiveNeoadjuvantLiposomal doxorubicinPaclitaxelTrastuzumabPertuzumabSafety

Outcome Measures

Primary Outcomes (1)

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

    Following 12 months after first dose of the study treatment

Secondary Outcomes (11)

  • pCR in breast (pCRB)

    At the time of definitive surgery, an expected average of 23 weeks

  • pCR in breast and axilla (pCRBA)

    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

    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

    At the time of definitive surgery, an expected average of 23 weeks

  • Breast conservation rate at surgery

    At the time of definitive surgery, an expected average of 23 weeks

  • +6 more secondary outcomes

Study Arms (1)

Liposomal Doxorubicin

EXPERIMENTAL

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

Interventions

Liposomal DoxorubicinDRUG

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

Also known as: Myocet® (liposome-encapsulated doxorubicin)
Liposomal Doxorubicin

Eligibility Criteria

Age18 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitario Vall d´Hebron

Barcelona, Spain

Location

Complejo Hospitalario San Pedro de Alcántara

Cáceres, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Centro Integral Oncológico Clara Campal

Madrid, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro de Majadahonda

Madrid, Spain

Location

MD Anderson Cancer Center Madrid

Madrid, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, Spain

Location

Hospital Sant Joan de Reus

Reus, Spain

Location

Hospital Sagrado Corazón USP

Seville, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Virgen de la Macarena

Seville, Spain

Location

Fundación Instituto Valenciano de Oncología

Valencia, Spain

Location

Hospital Arnau de Vilanova de Valencia

Valencia, Spain

Location

Hospital Universitario Lozano Blesa

Zaragoza, Spain

Location

Related Publications (2)

  • Gavilá J, Llombart A, Guerrero A, Ruíz A, Climent M, Guillem V. Opti-HER HEART: A prospective, multicenter, single-arm, phase II study to evaluate the safety of neoadjuvant liposomal doxorubicin plus paclitaxel, trastuzumab, and pertuzumab in patients with operable HER2-positive breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.

    BACKGROUND

  • Gavila J, Oliveira M, Pascual T, Perez-Garcia J, Gonzalez X, Canes J, Pare L, Calvo I, Ciruelos E, Munoz M, Virizuela JA, Ruiz I, Andres R, Perello A, Martinez J, Morales S, Marin-Aguilera M, Martinez D, Quero JC, Llombart-Cussac A, Prat A. Safety, activity, and molecular heterogeneity following neoadjuvant non-pegylated liposomal doxorubicin, paclitaxel, trastuzumab, and pertuzumab in HER2-positive breast cancer (Opti-HER HEART): an open-label, single-group, multicenter, phase 2 trial. BMC Med. 2019 Jan 9;17(1):8. doi: 10.1186/s12916-018-1233-1.

    PMID: 30621698DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinDoxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Joaquín Gavilá Gregori, MD

    Fundación Instituto Valenciano de Oncología

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 20, 2012

Study Start

June 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

November 6, 2017

Record last verified: 2017-10

Locations

ES(19)