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Breast CancerPhase 2Opti-HERNCT01669239

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

A Phase 2 study testing Liposomal Doxorubicin in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 19 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 74 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Liposomal Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
19 sitesSpain
Study dates
Jun 2013to Jan 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Spain19 sites

  • Hospital Clínic de Barcelona

    Barcelona

  • Hospital Universitario Vall d´Hebron

    Barcelona

  • Complejo Hospitalario San Pedro de Alcántara

    Cáceres

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncológico Clara Campal

    Madrid

  • Hospital Universitario Clínico San Carlos

    Madrid

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid

  • MD Anderson Cancer Center Madrid

    Madrid

  • Hospital Universitario Virgen de la Arrixaca

    Murcia

  • Hospital Son Llàtzer

    Palma de Mallorca

  • Hospital Universitari Son Espases

    Palma de Mallorca

  • Hospital Sant Joan de Reus

    Reus

  • Hospital Sagrado Corazón USP

    Seville

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Virgen de la Macarena

    Seville

  • Fundación Instituto Valenciano de Oncología

    Valencia

  • Hospital Arnau de Vilanova de Valencia

    Valencia

  • Hospital Universitario Lozano Blesa

    Zaragoza

Other trials in Spain

About this study

Official title: 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

Conditions
Breast Cancer
Being tested
Liposomal Doxorubicin
Keywords
Breast Cancer, HER2 positive, Neoadjuvant, Liposomal doxorubicin, Paclitaxel, Trastuzumab, Pertuzumab, Safety
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal DoxorubicinDrug

    Also called Myocet® (liposome-encapsulated 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
Study groups in NCT01669239
Study groupRoleWhat they receive
Liposomal DoxorubicinExperimentalSix 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
Receives: Drug: Liposomal Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Following 12 months after first dose of the study treatment

Secondary outcomes (11)

  1. pCR in breast (pCRB)

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

  2. pCR in breast and axilla (pCRBA)

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

  3. Clinical objective response rate (cORR) in the breast and axilla by RECIST criteria version 1.1

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

  4. Residual Cancer Burden (RCB) at surgery following the procedures of the MD Anderson Cancer Center

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

  5. Breast conservation rate at surgery

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

  6. Evaluation of serum biomarkers predictive of cardiotoxicity

    Measured: Following 12 months after first dose of the study treatment

  7. Percentage of patients with grade 3/4 neutropenia (assessed by CTCAE v.4)

    Measured: Following 12 months after first dose of the study treatment

  8. Time of onset and time of recovery from symptomatic (type A) and asymptomatic (type B) cardiac events (assessed by CTCAE v.4)

    Measured: Following 12 months after first dose of the study treatment

  9. Dose reductions due to treatment toxicity (assessed by CTCAE v.4)

    Measured: Following 12 months after first dose of the study treatment

  10. Dose delays due to treatment toxicity (assessed by CTCAE v.4)

    Measured: Following 12 months after first dose of the study treatment

  11. Number of patients with adverse events and serious adverse events (assessed by CTCAE v.4)

    Measured: Following 12 months after first dose of the study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2012 (estimated)
  2. Study startJun 2013
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01669239
Sponsor's protocol ID
SOLTI-1002
Other IDs
2012-001201-24
Acronym
Opti-HER
Status last verified
Oct 2017
First submitted
9 Aug 2012
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

  • 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.

    PubMed 30621698

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liposomal Doxorubicin in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 19 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01669239, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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