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

NCT ID: NCT01669239

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-01-31

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

Conditions

Breast Cancer

Keywords

Breast Cancer; HER2 positive; Neoadjuvant; Liposomal doxorubicin; Paclitaxel; Trastuzumab; Pertuzumab; Safety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Liposomal Doxorubicin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Myocet® (liposome-encapsulated doxorubicin)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SOLTI Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joaquín Gavilá Gregori, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Instituto Valenciano de Oncología

Locations

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital Universitario Vall d´Hebron

Barcelona, , Spain

Complejo Hospitalario San Pedro de Alcántara

Cáceres, , Spain

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Centro Integral Oncológico 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

Madrid, , Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, , Spain

Hospital Son Llàtzer

Palma de Mallorca, , Spain

Hospital Universitari Son Espases

Palma de Mallorca, , Spain

Hospital Sant Joan de Reus

Reus, , Spain

Hospital Sagrado Corazón USP

Seville, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Virgen de la Macarena

Seville, , Spain

Fundación Instituto Valenciano de Oncología

Valencia, , Spain

Hospital Arnau de Vilanova de Valencia

Valencia, , Spain

Hospital Universitario Lozano Blesa

Zaragoza, , Spain

Countries

Spain

References

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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 30621698 (View on PubMed)

Related Links

http://www.gruposolti.org

SOLTI Breast Cancer Research Group

Other Identifiers

2012-001201-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SOLTI-1002

Identifier Type: -

Identifier Source: org_study_id