AzTrials
AzTrials

Breast CancerPhase 3ESCAPENCT02194166

A Study to Investigate the Tolerability of Subcutaneous (SC) Trastuzumab Administration in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early Breast Cancer (eBC) Using Either a Single-Use Injection Device or Manual Administration

A Phase 3 study testing Trastuzumab, Paclitaxel and Docetaxel in people with Breast Cancer, run by Hoffmann-La Roche at 7 sites in 2 countries.

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 multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab, Paclitaxel and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
7 sitesin 2 countries
Study dates
18 Jul 2014to 12 Jul 2018
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Hormonal therapy allowed as per institutional guidelines
  • Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 55 percent (%) measured by echocardiography (ECHO) prior to first dose of trastuzumab
  • HER2-positive disease immunohistochemistry (IHC) 3+ or in-situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
  • Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
  • No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
  • Participants who have completed all (neo)adjuvant treatment or participants after adjuvant chemotherapy with doxorubicin and cyclophosphamide (AC) to whom the 4 subsequent cycles of trastuzumab in combination with paclitaxel or docetaxel are indicated per local practice
  • Not more than 3 months should have elapsed since the last dose of adjuvant chemotherapy in case of subsequent treatment scheme

Who cannot join

  • Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
  • History of other malignancy that can affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and participants with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible. Participants with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study
  • Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
  • Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
  • Prior maximum cumulative dose of doxorubicin >360 mg/m2 or maximum cumulative dose of epirubicin >720 mg/m2 or equivalent
  • Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension
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  • Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Pregnant or lactating women
  • Concurrent enrollment in another clinical trial using an investigational anticancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
  • Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin®, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g., difficult to control asthma
  • Inadequate bone marrow, hepatic, or renal function
  • Major surgical procedure or significant traumatic injury within 14 days prior to the first dose of study treatment or anticipated need for major surgery during the course of study treatment

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Belarus4 sites

  • State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology

    A/g Lesnoy, Minsk Region, 223040

  • Healthcare Institution "Brest Regional Oncologic Dispensary"

    Brest, 224027

  • Minsk City Clinical Oncologic Dispensary

    Minsk, BU-220013

  • Vitebsk Regional Clinical Oncology Dispensary

    Vitebsk, BU-210603

Other trials in Belarus

Kazakhstan3 sites

  • Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department

    Almaty, 050022

  • Almaty Cancer Hospital; Chemotherapy department

    Almaty, 050054

  • Oncology centre of Astana; Chemotherapy department

    Astana, 010000

Other trials in Kazakhstan

About this study

Official title: An Open-Label, Randomized, Cross-Over, Multicenter, Phase IIIb Study, to Assess Patients' Tolerability of Trastuzumab Administrated Subcutaneously (SC) Either Via a Single Use Injection Device (SID) or Via Vial for Manual Administration (SC Vial) in Patients With HER2-Positive Early Breast Cancer (eBC)

This multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles of intravenous [IV] and 14 cycles of SC trastuzumab).

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab IV or SC will be administered as described.

  • PaclitaxelDrug

    Paclitaxel will be administered in accordance with local hospital practice.

  • DocetaxelDrug

    Docetaxel will be administered in accordance with local hospital practice.

Study groups in NCT02194166
Study groupRoleWhat they receive
Pre-Randomization (Trastuzumab IV)ExperimentalTrastuzumab IV will be given during the first 4 cycles for all participants before randomization for SC administration. A dose of 6 milligrams per kilogram (mg/kg) will be given every 3 weeks. All the participants will require a loading dose on Day 1 of Cycle 1, so they will receive 8 mg/kg followed by 6 mg/kg, 3 weeks later and then 3-weekly. Concurrent administration during the first 4 cycles of trastuzumab IV with paclitaxel/docetaxel will have to be performed in accordance with local hospital practice.
Receives: Drug: Trastuzumab; Drug: Paclitaxel; Drug: Docetaxel
Group A: Trastuzumab SC (First Vial Formulation, then SID)ExperimentalParticipants will receive 7 cycles of SC trastuzumab 600 mg with assisted administration using a conventional syringe and needle (SC vial formulation) followed by 7 cycles of SC trastuzumab 600 mg SID administration after cross-over.
Receives: Drug: Trastuzumab
Group B: Trastuzumab SC (First SID, then Vial Formulation)ExperimentalParticipants will start with 7 cycles of SC trastuzumab 600 mg administration via SID and after cross-over will receive 7 injections of trastuzumab 600 mg with assisted administration using a conventional syringe and needle (SC vial formulation).
Receives: Drug: Trastuzumab

What is being measured

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

  1. Participant Pain as Measured on a 10 Centimeter (cm) Visual Analogue Scale

    Measured: Week 13 up to Week 52

  2. Participant Discomfort as Measured on a 10 cm Visual Analogue Scale

    Measured: Week 13 up to Week 52

Secondary outcomes (12)

  1. Healthcare Professional Satisfaction With SC Formulation as Assessed by Health Care Professional Questionnaire (HCPQ)

    Measured: Week 22

  2. Patient Satisfaction With SC Formulation as Assessed by Patients Satisfaction Questionnaire (PSQ)

    Measured: Week 52

  3. Healthcare Professional Perceived Time Savings With SC Trastuzumab as Assessed by HCPQ

    Measured: Week 22

  4. Percentage of Participants With Adverse Events

    Measured: Baseline up to approximately 3 years

  5. Overall Survival

    Measured: From first study treatment to death from any cause, assessed up to approximately 4.5 years

  6. Disease-Free Survival, Assessed as per Institutional Practice or American Society of Clinical Oncology (ASCO) Adjuvant Follow-up Guidelines 2006

    Measured: From first study treatment to documented disease progression or death, assessed up to approximately 3 years

  7. Number of Days on Trastuzumab Treatment

    Measured: Week 1 up to Week 52

  8. Total Daily Dose of Trastuzumab

    Measured: Week 1 up to Week 52

  9. Cumulative Dose of Trastuzumab

    Measured: Week 1 up to Week 52

  10. Duration of Treatment

    Measured: Week 1 up to Week 52

  11. Duration of Safety Observation

    Measured: 28 days after last study treatment (up to Week 56)

  12. Duration of Follow-Up

    Measured: 25 months after last study treatment (up to 3 years)

Timeline

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

  1. First posted18 Jul 2014 (estimated)
  2. Study start18 Jul 2014
  3. Primary completion12 Jul 2018
  4. Study completion12 Jul 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02194166
Sponsor's protocol ID
ML28839
Acronym
ESCAPE
Status last verified
Jun 2019
First submitted
8 Jul 2014
Last updated
10 Jun 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab, Paclitaxel and Docetaxel in people with Breast Cancer, run by Hoffmann-La Roche at 7 sites in 2 countries.

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 8 inclusion and 12 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 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Belarus, Kazakhstan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Participant Pain as Measured on a 10 Centimeter (cm) Visual Analogue Scale (time frame: Week 13 up to Week 52). The study lists 2 primary outcomes in all. 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 NCT02194166.

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 10 Jun 2019.

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