Breast NeoplasmsBREAST-HDCTNCT02860585
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
An observational study of Breast Neoplasms, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 235 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2013to 29 Feb 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: female patients treated for Metastatic breast Cancer with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation at the Institut Paoli-Calmettesbetween 2003 and 2012
Who may be able to join
- Age>18 years
- Metastatic breast Cancer
- Treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation between 2003 and 2012
Who cannot join
- Lack of follow-up data
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation.
- Conditions
- Breast Neoplasms
- Keywords
- Metastatic breast cancer, high-dose chemotherapy, autologous haematopoietic progenitor cell transplantation
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival according to Immunohistochemical subtypes .
Measured: 8 years
Secondary outcomes (1)
Progression free Survival according to Immunohistochemical subtypes .
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start27 Sep 2013
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Chabannon, MD,PhD, Study director, Institut Paoli-CalmettesAnthony Gonçalves, MD,PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860585
- Sponsor's protocol ID
- BREAST-HDCT-IPC 2014-001
- Acronym
- BREAST-HDCT
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02860585
- Acronym / sponsor ID
- BREAST-HDCT / BREAST-HDCT-IPC 2014-001
- Conditions
- Breast Neoplasms
- Keywords
- Metastatic breast cancer, high-dose chemotherapy, autologous haematopoietic progenitor cell transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 27 Sep 2013 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 9 Aug 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.
The objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patients treated for Metastatic breast Cancer with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation at the Institut Paoli-Calmettesbetween 2003 and 2012
Key inclusion criteria (3 listed)
- Age>18 years
- Metastatic breast Cancer
- Treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation between 2003 and 2012
Key exclusion criteria (1 listed)
- Lack of follow-up data
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
Overall Survival according to Immunohistochemical subtypes .
Time frame: 8 years
1 secondary outcome
Progression free Survival according to Immunohistochemical subtypes .
Time frame: 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 26 Sep 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.
Christian Chabannon, MD,PhD study director
Institut Paoli-Calmettes
Anthony Gonçalves, MD,PhD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Institut Paoli-Calmettes at 1 site in France.
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 3 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 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Overall Survival according to Immunohistochemical subtypes . (time frame: 8 years). 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 26 Sep 2017.