Breast CancerNCT02761616
A Study to Determine Biopsy Rate in Participants With a First Relapse of Breast Cancer
An observational study of Breast Cancer, run by Hoffmann-La Roche at 4 sites in Argentina.
Trial summary
This is a retrospective, and observational cohort study to determine the proportion of breast cancer first relapses, that are biopsied. The duration of the study will be approximately 24 months. 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?
- eBC treated participants
- How many people
- 76 participants
- Where
- 4 sitesArgentina
- Study dates
- Jun 2016to Nov 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a first relapse of breast cancer after being treated for eBC.
Who may be able to join
- Participants with histologically confirmed breast cancer treated for early breast cancer (eBC) with first metastatic relapse disease in the period from January 1, 2014 and December 31, 2015
Who cannot join
- Not Applicable
Trial locations and contacts
4 sites in 1 country.
Argentina4 sites
Cemic; Oncologia Clinica
Buenos Aires, C1431FWO
Hospital de Morón
Morón
CENICLAR
Rosario
Centro Medico San Roque
San Miguel de Tucumán, T4000IAK
About this study
This is a retrospective, and observational cohort study to determine the proportion of breast cancer first relapses, that are biopsied. The duration of the study will be approximately 24 months.
- Conditions
- Breast Cancer
- Being tested
- eBC treated participants
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eBC treated participantsOther
No intervention administered in this retrospective observational study.
| Study group | Role | What they receive |
|---|---|---|
| eBC treated participants | Participants with metastatic disease after previously being treated for eBC were observed for 24 months. Receives: Other: eBC treated participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of biopsied participants with metastatic relapse
Measured: Approximately up to 24 months
Secondary outcomes (10)
Percentage of non-biopsied participants at first relapse according to different reasons for not performing a biopsy of the metastasis
Measured: Approximately up to 24 months
Percentage of biopsied and non-biopsied participants at first relapse metastatic breast cancer (mBC) for each metastatic site
Measured: Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC according to each biopsy method
Measured: Approximately up to 24 months
Percentage of biopsied and non- biopsied participants at first relapse mBC for each molecular profile of primary tumor
Measured: Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC for each molecular profile of biopsied metastases
Measured: Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC with same and different molecular profiles between primary tumor and metastasis for each molecular profile
Measured: Approximately up to 24 months
Time to relapse
Measured: Approximately up to 24 months
Percentage of participants with type of first line therapy selected for metastatic disease
Measured: Approximately up to 24 months
Percentage of participants influenced with biopsy in mBC
Measured: Approximately up to 24 months
Percentage of biopsied and non- biopsied participants at first relapse mBC for each systemic treatment scheme in the adjuvant and in the metastatic setting
Measured: Approximately up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionNov 2016
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
- Retrospective
- Enrolment
- 76 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
- NCT02761616
- Sponsor's protocol ID
- ML30038
- Status last verified
- Jan 2017
- First submitted
- 3 May 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine Biopsy Rate in Participants With a First Relapse of Breast Cancer
- ClinicalTrials.gov ID
- NCT02761616
- Acronym / sponsor ID
- ML30038
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 May 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 is a retrospective, and observational cohort study to determine the proportion of breast cancer first relapses, that are biopsied. The duration of the study will be approximately 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eBC treated participants | – | Other: eBC treated participantsParticipants with metastatic disease after previously being treated for eBC were observed for 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a first relapse of breast cancer after being treated for eBC.
Key inclusion criteria (1 listed)
- Participants with histologically confirmed breast cancer treated for early breast cancer (eBC) with first metastatic relapse disease in the period from January 1, 2014 and December 31, 2015
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eBC treated participantsNo intervention administered in this retrospective observational study. | Other | eBC treated participants |
Primary outcome
Percentage of biopsied participants with metastatic relapse
Time frame: Approximately up to 24 months
10 secondary outcomes
Percentage of non-biopsied participants at first relapse according to different reasons for not performing a biopsy of the metastasis
Time frame: Approximately up to 24 months
Percentage of biopsied and non-biopsied participants at first relapse metastatic breast cancer (mBC) for each metastatic site
Time frame: Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC according to each biopsy method
Time frame: Approximately up to 24 months
Percentage of biopsied and non- biopsied participants at first relapse mBC for each molecular profile of primary tumor
Time frame: Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC for each molecular profile of biopsied metastases
Time frame: Approximately up to 24 months
Percentage of biopsied participants at first relapse mBC with same and different molecular profiles between primary tumor and metastasis for each molecular profile
Time frame: Approximately up to 24 months
Time to relapse
Time frame: Approximately up to 24 months
Percentage of participants with type of first line therapy selected for metastatic disease
Time frame: Approximately up to 24 months
Percentage of participants influenced with biopsy in mBC
Time frame: Approximately up to 24 months
Percentage of biopsied and non- biopsied participants at first relapse mBC for each systemic treatment scheme in the adjuvant and in the metastatic setting
Time frame: Approximately up to 24 months
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 1 Feb 2017.
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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.
Clinical Trials study director
Hoffmann-La Roche
4 sites in 1 country: 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 4 sites in Argentina.
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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina. 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?
Percentage of biopsied participants with metastatic relapse (time frame: Approximately up to 24 months). 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 1 Feb 2017.