Breast CancerNCT02745262
Overall Survival and Disease-free Survival in Breast Cancer Patients Under COS
An observational study of Breast Cancer, run by IVI Vigo.
Trial summary
The main objective of the study is to evaluate the overall survival and disease-free survival in breast cancer patients under 40 years old. They underwent controlled ovarian stimulation (COS) for fertility preservation versus women of the same age, type and stage of breast cancer, who have not been subjected to COS. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Collect retrospectively the follow-up data
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2018
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Age under 40 years ( at the time of diagnosis) TNM stage I- II Authorization of the fertility preservation multidisciplinary committee
Who may be able to join
- Age under 40 years ( at the time of diagnosis)
- TNM stage I- II
- Authorization of the fertility preservation multidisciplinary committee
Who cannot join
- Contraindications for pregnancy
- previous history of infertility
- Previous history of ovarian surgery
- Prior chemotherapy
- History of pelvic radiation
- Diabetes Mellitus
Show all 10Show fewer
- Hypertension
- renal failure
- liver failure
- autoimmune disease.
About this study
Official title: Retrospective Cohort Study of Overall Survival and Disease-free Survival in Breast Cancer Patients Who Underwent Controlled Ovarian Stimulation (COS)
The main objective of the study is to evaluate the overall survival and disease-free survival in breast cancer patients under 40 years old. They underwent controlled ovarian stimulation (COS) for fertility preservation versus women of the same age, type and stage of breast cancer, who have not been subjected to COS.
Read the detailed description
Breast cancer is a disease where the tumor size, lymph node involvement and histological grade provide rich information about prognosis and enable to stage the disease. As in any other oncological pathology, stage of disease at diagnosis is the major determining factor for estimating survival. Ovarian stimulation for fertility preservation is performed in this study, in patients with stage I-II (TNM) after the neoplasia is treated (surgical removal of the tumor) prior to systemic therapy, when indicated.
Among young women there is a greater incidence of basal type tumors and HER2 (human epidermal growth factor receptor 2), which do not always express hormone receptors. In early stages of the disease, the controlled ovarian stimulation procedure, after removal of the tumor, has not revealed any worsening in the prognosis of the disease, in terms of overall survival and disease-free survival (absence of local or distant recurrence).
It is a study that aims to collect data retrospectively from 2008 to 31 December 2015. To this end, we will collect the follow-up data, up to 5 years for patients from 2008, 2009 and 2010. Four years for patients in 2011, 3 years for 2012, 2 years for 2013, one year for those included until 31 December 2014 and patients followed until 31 December 2015. Each patient is called in order to request data authorization, to complete and track information.
- Conditions
- Breast Cancer
- Being tested
- Collect retrospectively the follow-up data
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect retrospectively the follow-up dataOther
Collect retrospectively the follow-up data. Each patient is called in order to request data authorization, to complete and track information.
| Study group | Role | What they receive |
|---|---|---|
| Controlled ovarian stimulation | No drugs are administered. It is an observational study. Collect retrospectively the follow-up data Receives: Other: Collect retrospectively the follow-up data | |
| Non Controlled ovarian stimulation | No drugs are administered. It is an observational study. Collect retrospectively the follow-up data Receives: Other: Collect retrospectively the follow-up data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elkin Muñoz, Principal investigator, IVI Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745262
- Sponsor's protocol ID
- 1405-VIG-030-EM
- Status last verified
- Apr 2016
- First submitted
- 13 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cobo A, Garcia-Velasco JA, Domingo J, Remohi J, Pellicer A. Is vitrification of oocytes useful for fertility preservation for age-related fertility decline and in cancer patients? Fertil Steril. 2013 May;99(6):1485-95. doi: 10.1016/j.fertnstert.2013.02.050. Epub 2013 Mar 29.
PubMed 23541405Oktay K, Rodriguez-Wallberg K, Munster P. Ovarian protection during adjuvant chemotherapy. N Engl J Med. 2015 Jun 4;372(23):2268-9. doi: 10.1056/NEJMc1504241. No abstract available.
PubMed 26039611Frydman R, Grynberg M. Introduction: Female fertility preservation: innovations and questions. Fertil Steril. 2016 Jan;105(1):4-5. doi: 10.1016/j.fertnstert.2015.10.035. Epub 2015 Nov 21.
PubMed 26612064
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study of Overall Survival and Disease-free Survival in Breast Cancer Patients Who Underwent Controlled Ovarian Stimulation (COS)
- ClinicalTrials.gov ID
- NCT02745262
- Acronym / sponsor ID
- 1405-VIG-030-EM
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- IVI VigoUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 20 Apr 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 main objective of the study is to evaluate the overall survival and disease-free survival in breast cancer patients under 40 years old. They underwent controlled ovarian stimulation (COS) for fertility preservation versus women of the same age, type and stage of breast cancer, who have not been subjected to COS.
Detailed description
Breast cancer is a disease where the tumor size, lymph node involvement and histological grade provide rich information about prognosis and enable to stage the disease. As in any other oncological pathology, stage of disease at diagnosis is the major determining factor for estimating survival. Ovarian stimulation for fertility preservation is performed in this study, in patients with stage I-II (TNM) after the neoplasia is treated (surgical removal of the tumor) prior to systemic therapy, when indicated.
Among young women there is a greater incidence of basal type tumors and HER2 (human epidermal growth factor receptor 2), which do not always express hormone receptors. In early stages of the disease, the controlled ovarian stimulation procedure, after removal of the tumor, has not revealed any worsening in the prognosis of the disease, in terms of overall survival and disease-free survival (absence of local or distant recurrence).
It is a study that aims to collect data retrospectively from 2008 to 31 December 2015. To this end, we will collect the follow-up data, up to 5 years for patients from 2008, 2009 and 2010. Four years for patients in 2011, 3 years for 2012, 2 years for 2013, one year for those included until 31 December 2014 and patients followed until 31 December 2015. Each patient is called in order to request data authorization, to complete and track information.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled ovarian stimulation | – | Other: Collect retrospectively the follow-up dataNo drugs are administered. It is an observational study. Collect retrospectively the follow-up data |
| Non Controlled ovarian stimulation | – | Other: Collect retrospectively the follow-up dataNo drugs are administered. It is an observational study. Collect retrospectively the follow-up data |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Age under 40 years ( at the time of diagnosis) TNM stage I- II Authorization of the fertility preservation multidisciplinary committee
Key inclusion criteria (3 listed)
- Age under 40 years ( at the time of diagnosis)
- TNM stage I- II
- Authorization of the fertility preservation multidisciplinary committee
Key exclusion criteria (10 listed)
- Contraindications for pregnancy
- previous history of infertility
- Previous history of ovarian surgery
- Prior chemotherapy
- History of pelvic radiation
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 |
|---|---|---|
| Collect retrospectively the follow-up dataCollect retrospectively the follow-up data. Each patient is called in order to request data authorization, to complete and track information. | Other | Controlled ovarian stimulation, Non Controlled ovarian stimulation |
Primary outcome
Overall survival rate
Time frame: Up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Results publication: PubMed 23541405Cobo A, Garcia-Velasco JA, Domingo J, Remohi J, Pellicer A. Is vitrification of oocytes useful for fertility preservation for age-related fertility decline and in cancer patients? Fertil Steril. 2013 May;99(6):1485-95. doi: 10.1016/j.fertnstert.2013.02.050. Epub 2013 Mar 29.
- Results publication: PubMed 26039611Oktay K, Rodriguez-Wallberg K, Munster P. Ovarian protection during adjuvant chemotherapy. N Engl J Med. 2015 Jun 4;372(23):2268-9. doi: 10.1056/NEJMc1504241. No abstract available.
- Results publication: PubMed 26612064Frydman R, Grynberg M. Introduction: Female fertility preservation: innovations and questions. Fertil Steril. 2016 Jan;105(1):4-5. doi: 10.1016/j.fertnstert.2015.10.035. Epub 2015 Nov 21.
- Individual participant dataSharing planned: No
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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.
Elkin Muñoz principal investigator
IVI Vigo
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by IVI Vigo.
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 10 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 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Overall survival rate (time frame: Up to 60 months). 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 NCT02745262, which also lists 3 linked publications.
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 20 Apr 2016.