Retrospective Data Collection: Post Study Treatment Anticancer Therapy From IMELDA MO22223

An observational study of Breast Cancer, run by Hoffmann-La Roche at 32 sites in 6 countries.

Completed

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

Trial summary

This study aims to understand better the effective results from the IMELDA MO22223 P-trial (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after study treatments were terminated possibly had an effect on efficacy results. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
How many people: 185 participants
Where: 32 sitesin 6 countries
Study dates: 30 Apr 2015to 22 Jan 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: All participants randomized in IMELDA (MO22223)

Who may be able to join

Having been randomized in the IMELDA MO22223 P-trial

Who cannot join

Not having been randomized in the IMELDA MO22223 P-trial

Trial locations and contacts

32 sites in 6 countries.

Country

City, postcode or hospital

32 sites in 6 countries

Brazil8 sites

Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-550
Hospital de Caridade de Ijui; Oncologia
Ijuí, Rio Grande do Sul, 98700-000
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-080
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-003
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, Rio de Janeiro, 20560-120
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
Santo André, São Paulo, 09060-650
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
Hospital Santa Marcelina;Oncologia
São Paulo, São Paulo, 08270-070

Other trials in Brazil

France8 sites

HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030
Chg de Chartres Hopital Louis Pasteur; Pneumologie
Chartres, 28018
Clinique Sainte Marguerite; Oncologie Medicale
Hyères, 83400
Centre Bourgogne, Service de Radiotherapie
Lille, 59000
Institut Curie; Oncologie Medicale
Paris, 75231
HOPITAL TENON; Cancerologie Medicale
Paris, 75970
Clinique Francheville; Radiotherapie
Périgueux, 24000
Institut D Oncologie Medical
Strasbourg, 67000

Other trials in France

Spain8 sites

Complejo Hospitalario la Mancha Centro;Servicio Oncologia
Alcazar de S. Juan, Ciudad Real, 13600
Hospital Virgen de los Lirios; Servicio de Oncologia
Alcoy, Alicante, 03804
Hospital de Cruces; Servicio de Oncologia
Barakaldo, Vizcaya, 48903
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 08208
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo, 45004
Hospital Universitario la Fe; Servicio de Oncologia
Valencia, 46026

Other trials in Spain

Italy3 sites

Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Apulia, 72100
Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico
Genoa, Liguria, 16132
Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica
Naples, Campania, 80131

Other trials in Italy

Turkey (Türkiye)3 sites

Gazi Uni Medical Faculty Hospital; Oncology Dept
Ankara, 06500
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, 07070
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

India2 sites

Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, 400012
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, National Capital Territory of Delhi, 110085

Other trials in India

About this study

Official title: Retrospective Data Collection: Post Study Treatment Anticancer Therapy From All Randomized Patients Involved in IMELDA MO22223

Conditions: Breast Cancer
Being tested: No Intervention
Medical subject headings: Breast Neoplasms

What participants receive

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

No InterventionOther
No intervention administered in this study.

Study groups in NCT02383576
Study group	Role	What they receive
Bevacizumab		Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed. Receives: Other: No Intervention
Bevacizumab and Capecitabine		Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed. Receives: Other: No Intervention

What is being measured

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

Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy
Participants who had prematurely withdrawn from maintenance study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Measured: Up to 78 months
Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment
Participants who received further anti-cancer therapies after discontinuation of study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Measured: Up to 78 months
Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy
Time from last maintenance study medication to the start of any further anti-cancer therapy was reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Measured: Up to 78 months
Progression Free Survival (PFS)
PFS was defined as the time from start of the study to the first documented occurrence of disease progression. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Measured: Up to 78 months
Overall Survival
Overall survival was defined as the interval between start of the study and the date of death from any cause. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Measured: Up to 78 months

Timeline

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

30 Apr 201522 Jan 2016

First posted9 Mar 2015 (estimated)
Study start30 Apr 2015
Primary completion22 Jan 2016
Study completion22 Jan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Retrospective
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02383576
Sponsor's protocol ID: MO29587
Status last verified: Sep 2017
First submitted: 4 Mar 2015
Last updated: 13 Apr 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retrospective Data Collection: Post Study Treatment Anticancer Therapy From All Randomized Patients Involved in IMELDA MO22223
ClinicalTrials.gov ID: NCT02383576
Acronym / sponsor ID: MO29587
Conditions: Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 30 Apr 2015 (actual)
Primary completion: 22 Jan 2016 (actual)
Study completion: 22 Jan 2016 (actual)
First posted: 9 Mar 2015 (estimated)
Results: Posted 13 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Bevacizumab	–	Other: No InterventionParticipants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Bevacizumab and Capecitabine	–	Other: No InterventionParticipants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All participants randomized in IMELDA (MO22223)

Key inclusion criteria (1 listed)

Having been randomized in the IMELDA MO22223 P-trial

Key exclusion criteria (1 listed)

Not having been randomized in the IMELDA MO22223 P-trial

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
No InterventionNo intervention administered in this study.	Other	Bevacizumab, Bevacizumab and Capecitabine

Primary outcome

Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy
Time frame: Up to 78 months
Participants who had prematurely withdrawn from maintenance study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment
Time frame: Up to 78 months
Participants who received further anti-cancer therapies after discontinuation of study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy
Time frame: Up to 78 months
Time from last maintenance study medication to the start of any further anti-cancer therapy was reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Progression Free Survival (PFS)
Time frame: Up to 78 months
PFS was defined as the time from start of the study to the first documented occurrence of disease progression. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Overall Survival
Time frame: Up to 78 months
Overall survival was defined as the interval between start of the study and the date of death from any cause. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.

Results and safety

Results posted to the registry on 13 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bevacizumab	94	31
Bevacizumab and Capecitabine	91	46

Primary outcome: Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy

Time frame: Up to 78 months. Number. Unit: percentage of participants

Measure	Bevacizumab n = 59	Bevacizumab and Capecitabine n = 59
Value	93.2	84.7

Population analysed: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.

Primary outcome: Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment

Time frame: Up to 78 months. Number. Unit: percentage of participants

Measure	Bevacizumab n = 59	Bevacizumab and Capecitabine n = 59
Value	94.9	91.5

Primary outcome: Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy

Time frame: Up to 78 months. Median (Full Range). Unit: days

Measure	Bevacizumab n = 59	Bevacizumab and Capecitabine n = 59
Value	22.5 (0 to 70)	23.5 (0 to 630)

Primary outcome: Progression Free Survival (PFS)

Time frame: Up to 78 months. Median (95% Confidence Interval). Unit: months

Measure	Bevacizumab n = 59	Bevacizumab and Capecitabine n = 59
Value	4.3 (2.7 to 6.8)	12.2 (7.6 to 15.4)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bevacizumab	0 of 0	0 of 0	Not reported
Bevacizumab and Capecitabine	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingObservational study
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Cancer, Cancer Diagnosis
RecruitingPhase 3
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
Breast Cancer
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
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RecruitingObservational study
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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.

Reference Study ID Number: MO29587 www.roche.com/about_rouche/roche_worldwide.htm study director

Hoffmann-La Roche

32 sites in 6 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 32 sites in 6 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 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Brazil, France, Spain, Italy, Turkey (Türkiye) and 1 more country. 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?

Yes. Results are posted in the registry (first posted 13 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy (time frame: Up to 78 months). The study lists 5 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 NCT02383576.

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 13 Apr 2018.