Breast CancerPhase 3NCT00294996
Trial of Myocet in Metastatic Breast Cancer
A Phase 3 study testing Myocet in people with Breast Cancer, run by Sopherion Therapeutics at 105 sites in 11 countries.
Trial summary
The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Myocet
- How many people
- 363 participants
- Where
- 105 sitesin 11 countries
- Study dates
- Jan 2006to not given
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic Her2+ Breast cancer by FISH analysis
- No prior chemotherapy for metastatic disease
- Measurable disease
- normal left ventricular ejection fraction
Who cannot join
- prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2
- relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy
Trial locations and contacts
105 sites in 11 countries.
105 sites in 11 countries
United States18 sites
University of Colorado
Aurora, Colorado, 80045
Vita Hematology Oncology
Bethlehem, Pennsylvania, 18015
Aultman Hospital Cancer Center
Canton, Ohio, 44710
M. Francisco Gonzalez
Columbia, South Carolina, 29203
John B. Amos Cancer Center
Columbus, Georgia, 31904
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235
Northwest Hematology/Oncology Associates
Coral Springs, Florida, 33065
Western Maryland Health System
Cumberland, Maryland, 21502
Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania, 18512
Brody School of Medicine @ ECU
Greenville, North Carolina, 27834
Hutchinson Clinic P.A.
Hutchinson, Kansas, 67502
Osceola Cancer Center
Kissimmee, Florida, 34741
Tennessee Cancer Specialists
Knoxville, Tennessee, 37920
PA Oncology Hematology Asso
Philadelphia, Pennsylvania, 19106
UM/Sylvester Cancer Center
Plantation, Florida, 33324
Scripps Cancer Center Clinical Research
San Diego, California, 92121
Sioux Valley Clinic
Sioux Falls, South Dakota, 57104
Clintell, Inc
Skokie, Illinois, 60076
India17 sites
Gujarat Cancer Research Institute
Asarwa, Gujarat
Kidwai Memorial Institute of Oncology
Bangalore
Manipal Hospital
Bangalore
Apollo Specialty Hospitals, Chennai
Chennai
Nizam's Institute of Medical Science
Hyderabaad
SMSMedicalCollegeHospital,
Jaipur
Lakeshore Hospital and Research Centre Ltd
Kerala
Himadri cancer welfare trusr
Kolkata
Orchid Nursing Home,
Kolkata
Ruby Hall Clinic
Maharashtra
Tata Memorial Hospital
Maharashtra
Kasturba Medical College,
Mangalore
Jaslok Hospital and Research Centre
Mumbai
Batra Hospital & Medical Research Center
New Delhi
Indraprastha Apollo Hospitals
New Delhi
Safdarjung Hospital & Vardhaman Mahaveer Medical College
New Delhi
Fortis Hospital
Noida
Spain11 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitari Arnau de Vilanova de Lleida
Lleida
Hospital 12 de Octubre
Madrid
Hospital Son Dureta
Palma de Mallorca
Hospital Clínico Universitario de Salamanca
Salamanca
Hospital Virgen Macarena
Seville
Hospital Mutua de Terrassa
Terrassa
Hospital Clínico Universitario de Valencia
Valencia
Hospital General Universitario de Valencia
Valencia
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Argentina10 sites
Centro Oncologico de Excelencia
Buenos Aires
Hospital Enrique Tornú
Buenos Aires
Hospital Interzonal Gral de Agudos " EVITA"
Buenos Aires
Hospital Profesor A. Posadas
Buenos Aires
Santorio Municipal Dr. J. Mendez
Buenos Aires
Unidad Oncologica del Neuquen
Neuquén
CAICI Instituto
Santa Fe
Centro Oncologico Rosario
Santa Fe
ISIS Clinica Especializada
Santa Fe
Ceten
Villa Domínico
Canada10 sites
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
London Regional Cancer Centre/London Health Science Centre
London, Ontario, N6A 4L6
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
CHUM Hospital Notre-Dame
Montreal, Quebec, H2L 4M1
McGill University
Montreal, Quebec, H2W 1S6
The Ottawa Hospital Regional Cancer Center
Ottawa, Ontario, K1H 8L6
Hopital du St. Sacrement
Québec, G1S 4L8
Allan Blair Cancer Centre
Regina, Saskatchewan, S47 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Poland10 sites
SP SK nr1 ACK AMG
Gdansk
Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice
Gliwice
Regionalny Ośrodek Onkologiczny
Lodz
Samodzielny Publiczny Szpital
Lublin
Zakład Opieki Zdrowotnej MSWiA
Olsztyn
Regionalny Szpital Specjalistyczny
Swidnica
Szpital Wojewódzki im. Św. Łukasza
Tarnów
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
Warsaw
Wojskowy Instytut Medyczny
Warsaw
SP ZOZ Szpital Wojewódzki
Zielona Góra
Russia10 sites
Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company
Moscow
State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences
Moscow
State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development
Moscow
State Health Care Institution "Regional Clinical Oncology Dispensary"
Ryazan
Research Institute of Pulmonology affiliated with State Educational Institution "St. Petersburg State Medical University n.a. academician I.P. Pavlov" of the Federal Agency of Health Care and Social Development
Saint Petersberg
St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary"
Saint Petersberg
State Science Institution "Prof. N.N. Petrov Research Institute of Oncology" of the Federal Agency of Health Care and Social Development
Saint Petersberg
State Health Care Institution "Leningrad Regional Oncology Dispensary"
Saint Petersburg
Municipal Health Care Institution of the City of Sochi "Oncology Dispensary"
Sochi
State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary"
Yaroslavl
Germany7 sites
U.K Charité, Campus Mitte
Berlin
Universitätsklinikum Magdeburg
Magdeburg
Gemeinschaftspraxis Gynäkologie & Geburtshilfe
Mannheim
Frauenklinik von Roten Kreuz
München
Klinikum Offenbach
Offenbach
Üniversitäts Klinikum Tübingen
Tübingen
Dr. Horst Schmidt Kliniken
Wiesbaden
Italy7 sites
Azienda Ospedialera Pugliese-Ciaccio
Catanzaro
Clinica Oncologica Ospedale
Chieti
DIMI - Università di Genova
Genova
ARNAS CIVICO. Presidio Ospedaliero M. Ascoli
Palermo
Oncologia Medica
Pavia
Day Hospital Oncologico,
Roma
Istituto Clinico Humanitas
Rozzano
United Kingdom4 sites
Broomfield Hospital
Broomfield
Christie Hospital NHS Trust
Cardiff
Guy's Hospital
London
Royal Free Hospital
London
About this study
Official title: A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer
The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Myocet
- Keywords
- Metastatic Her2+ Breast cancer, Myocet, liposomal doxorubicin, trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyocetDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Secondary outcomes (2)
Overall Survival
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sopherion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jose Baselga, M.D., Principal investigator, Vall d'Hebron Hospital, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294996
- Sponsor's protocol ID
- STM01-102
- Status last verified
- Mar 2009
- First submitted
- 17 Feb 2006
- Last updated
- 31 Mar 2009
- Results posted
- No
Publications
Baselga J, Manikhas A, Cortes J, Llombart A, Roman L, Semiglazov VF, Byakhov M, Lokanatha D, Forenza S, Goldfarb RH, Matera J, Azarnia N, Hudis CA, Rozencweig M. Phase III trial of nonpegylated liposomal doxorubicin in combination with trastuzumab and paclitaxel in HER2-positive metastatic breast cancer. Ann Oncol. 2014 Mar;25(3):592-598. doi: 10.1093/annonc/mdt543. Epub 2014 Jan 8.
PubMed 24401928
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00294996
- Acronym / sponsor ID
- STM01-102
- Conditions
- Breast Cancer
- Keywords
- Metastatic Her2+ Breast cancer, Myocet, liposomal doxorubicin, trastuzumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Sopherion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- First posted
- 22 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Metastatic Her2+ Breast cancer by FISH analysis
- No prior chemotherapy for metastatic disease
- Measurable disease
- normal left ventricular ejection fraction
Key exclusion criteria (2 listed)
- prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2
- relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myocet | Drug | – |
Primary outcome
Progression-Free Survival
2 secondary outcomes
Overall Survival
Safety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2009.
- Derived from this study: PubMed 24401928Baselga J, Manikhas A, Cortes J, Llombart A, Roman L, Semiglazov VF, Byakhov M, Lokanatha D, Forenza S, Goldfarb RH, Matera J, Azarnia N, Hudis CA, Rozencweig M. Phase III trial of nonpegylated liposomal doxorubicin in combination with trastuzumab and paclitaxel in HER2-positive metastatic breast cancer. Ann Oncol. 2014 Mar;25(3):592-598. doi: 10.1093/annonc/mdt543. Epub 2014 Jan 8.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Baselga, M.D. principal investigator
Vall d'Hebron Hospital, Barcelona, Spain
105 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myocet in people with Breast Cancer, run by Sopherion Therapeutics at 105 sites in 11 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in United States, India, Spain, Argentina, Canada and 6 more countries. 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?
Results are not available in the source record.
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?
Progression-Free Survival. 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 NCT00294996, which also lists 1 linked publication.
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 31 Mar 2009.