Breast CancerNCT02913456
A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)
An observational study of Breast Cancer, run by Hoffmann-La Roche at 54 sites in 5 countries.
Trial summary
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 629 participants
- Where
- 54 sitesin 5 countries
- Study dates
- 16 Nov 2016to 31 Jan 2024
- Phase
- Observational
- 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
Study population: Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
Who may be able to join
- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
Who cannot join
- Not applicable
Trial locations and contacts
54 sites in 5 countries.
54 sites in 5 countries
Italy19 sites
A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
Ancona, The Marches, 60121
RCCS - Centro di Riferimento; Oncologia Medica B
Aviano (PN), Friuli Venezia Giulia, 33081
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, 70124
Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia
Barletta, Apulia, 70051
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Brescia, Lombardy, 25123
Ospedale Civile; Oncologia Medica
Camposampiero, Veneto, 35012
Ospedale Cannizzaro, Oncologia
Catania, Sicily, 95126
Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia
Cona (FE), Veneto, 44124
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
Florence, Tuscany, 50134
Ospedale S. Maria Goretti; Divisione Di Oncologia Medica
Latina, Lazio, 04100
Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia
Legnago (VR), Veneto, 37045
Ospedale San Luca; Oncologia
Lucca, Tuscany, 55100
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, 41124
Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
Palermo, Sicily, 90146
Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
Ponderano (BI), Piedmont, 13875
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Sant'Andrea Delle Fratte (PG), Umbria, 06132
Ospedale S.S. Trinità Nuovo; Divisione Oncologia
Sora, Lazio, 03039
A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
Verona, Veneto, 37134
Ospedale Belcolle Di Viterbo; Oncologia
Viterbo, Lazio, 01100
Austria11 sites
Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
Graz, 8036
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz, 8036
Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie
Klagenfurt, 9020
LKH Hochsteiermark; Abt. für Hämato-Onkologie
Leoben, 8700
Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT.
Linz, 4020
A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.
Ried-innkreis, 4910
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Vienna, 1090
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
Vienna, 1090
Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung
Vienna, 1140
A.Ö. Lhk Villach; Abt. Für Gynäkologie
Villach, 9500
Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie
Wiener Neustadt, 2700
Bulgaria11 sites
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, 4000
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, 4004
Mdozs - Russe
Rousse, 7000
MHAT Nadezhda
Sofia, 1330
Tokuda Hospital; Medical Oncology Department
Sofia, 1407
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527
SHATOD - Sofia
Sofia, 1784
Complex Oncology Center-Burgas; Medical Oncology
Sofia, 8018
District Oncology Dispensary; Dept of Chimiotherapy
Stara Zagora, 8000
District Oncology Dispensary Wit Stationary
Varna, 9010
Comprehensive Oncology Center - Vratsa
Vratsa, 3000
Romania7 sites
County Hospital Alba; Oncology
Alba Iulia, 510073
"Filantropia" Clinical Hospital; Gynecological Oncology
Bucharest, 011191
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
Bucharest, 022328
Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology
Cluj-Napoca, 400006
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015
Centrul de Oncologie Sfantul Nectarie
Craiova, 200347
Oncomed SRL
Timișoara, 300239
Portugal6 sites
Hospital Garcia de Orta; Servico de Oncologia Medica
Almada, 2801-951
IPO de Coimbra; Servico de Oncologia Medica
Coimbra, 3000-075
Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
Lisbon, 1150-314
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, 1649-035
Hospital Beatriz Angelo; Departamento de Oncologia
Loures, 2674-514
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072
About this study
Official title: A European Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive unresectable LA/mBC | Participants with HER2-positive unresectable LA/mBC diagnosed up to 6 months prior to enrollment will be included in the study. Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LA/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
Measured: Baseline up to 8 years
Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences
Measured: Baseline up to 8 years
Secondary outcomes (17)
Overall Survival
Measured: Baseline up to 8 years
Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
Measured: Baseline up to 8 years
Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
Measured: Baseline up to 8 years
Total Number of Treatment Regimens Received by Participants
Measured: Baseline up to 8 years
Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest
Measured: Baseline up to 8 years
Percentage of Participants with HER2 Re-testing of Metastases
Measured: Baseline up to 8 years
Percentage of Participants with Change in HER2 Status
Measured: Baseline up to 8 years
Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])
Measured: Baseline up to 8 years
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country
Measured: Baseline up to 8 years
Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens
Measured: Baseline up to 8 years
EuroQol 5-Dimensions Questionnaire (EQ-5D) Score
Measured: Baseline up to 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
Measured: Baseline up to 8 years
Total Healthcare Cost
Measured: Baseline up to 8 years
Cost of Treating Associated AEs
Measured: Baseline up to 8 years
Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures
Measured: Baseline up to 8 years
Resource Utilization: Percentage of Participants with Hospitalization
Measured: Baseline up to 8 years
Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits
Measured: Baseline up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start16 Nov 2016
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913456
- Sponsor's protocol ID
- MO39146
- Status last verified
- Mar 2024
- First submitted
- 22 Sep 2016
- Last updated
- 6 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02913456
- Acronym / sponsor ID
- MO39146
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 23 Sep 2016 (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.
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-positive unresectable LA/mBC | – | –Participants with HER2-positive unresectable LA/mBC diagnosed up to 6 months prior to enrollment will be included in the study. Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LA/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
Key inclusion criteria (1 listed)
- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
Time frame: Baseline up to 8 years
Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences
Time frame: Baseline up to 8 years
17 secondary outcomes
Overall Survival
Time frame: Baseline up to 8 years
Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
Time frame: Baseline up to 8 years
Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
Time frame: Baseline up to 8 years
Total Number of Treatment Regimens Received by Participants
Time frame: Baseline up to 8 years
Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest
Time frame: Baseline up to 8 years
Percentage of Participants with HER2 Re-testing of Metastases
Time frame: Baseline up to 8 years
Percentage of Participants with Change in HER2 Status
Time frame: Baseline up to 8 years
Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])
Time frame: Baseline up to 8 years
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country
Time frame: Baseline up to 8 years
Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens
Time frame: Baseline up to 8 years
EuroQol 5-Dimensions Questionnaire (EQ-5D) Score
Time frame: Baseline up to 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
Time frame: Baseline up to 8 years
Total Healthcare Cost
Time frame: Baseline up to 8 years
Cost of Treating Associated AEs
Time frame: Baseline up to 8 years
Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures
Time frame: Baseline up to 8 years
Resource Utilization: Percentage of Participants with Hospitalization
Time frame: Baseline up to 8 years
Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits
Time frame: Baseline up to 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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.
Clinical Trials study director
Hoffmann-La Roche
54 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hoffmann-La Roche at 54 sites in 5 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 1 inclusion and 1 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Italy, Austria, Bulgaria, Romania, Portugal. 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.
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?
Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice (time frame: Baseline up to 8 years). 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?
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 Mar 2024.