PregnancyBRCAPRENCT02102282
Breast Cancer During Pregnancy
An observational study of Pregnancy and Breast Cancer, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
Trial summary
Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy, Breast Cancer
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2012to Dec 2022
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with breast cancer diagnosed during pregnancy
Who may be able to join
- Patients with breast cancer diagnosed during pregnancy
Who cannot join
- Patients who refuse informed consent
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
Octavi Cordoba, PhD, MD, 34934893174, ocordoba@vhebron.net
Cristina Saura, MD, 34934893105, csaura@vhebron.net
About this study
Official title: Observational Study of Breast Cancer Diagnosed During Pregnancy
Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.
- Conditions
- Pregnancy, Breast Cancer
- Keywords
- Pregnancy, Breast Cancer, Chemotherapy, Surgery, Obstetric managment
- 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 |
|---|---|---|
| Subject study | Patients with breast cancer during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal results
Gestational age, weight, Apgar, blood tests
Measured: Delivery
Secondary outcomes (1)
Maternal outcome
Over all survival, disease free survival
Measured: 5 year and 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Octavi Cordoba, PhD MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102282
- Sponsor's protocol ID
- PR(AMI)83/2012
- Acronym
- BRCAPRE
- Status last verified
- Mar 2014
- First submitted
- 29 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cordoba O, Llurba E, Saura C, Rubio I, Ferrer Q, Cortes J, Xercavins J. Multidisciplinary approach to breast cancer diagnosed during pregnancy: maternal and neonatal outcomes. Breast. 2013 Aug;22(4):515-9. doi: 10.1016/j.breast.2012.10.005. Epub 2012 Oct 30.
PubMed 23116970Cordoba O, Llurba E, Cortes J, Sabadell MD, Lirola JL, Ferrer Q, Xercavins J. Complete pathological remission in a patient with hormone-receptor positive and c-erbB-2 expression-negative breast cancer treated with FAC chemotherapy during pregnancy. Tumori. 2010 Jul-Aug;96(4):629-32. doi: 10.1177/030089161009600420.
PubMed 20968147
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Breast Cancer Diagnosed During Pregnancy
- ClinicalTrials.gov ID
- NCT02102282
- Acronym / sponsor ID
- BRCAPRE / PR(AMI)83/2012
- Conditions
- Pregnancy, Breast Cancer
- Keywords
- Pregnancy, Breast Cancer, Chemotherapy, Surgery, Obstetric managment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2022 (estimated)
- First posted
- 2 Apr 2014 (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.
Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject study | – | –Patients with breast cancer during pregnancy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with breast cancer diagnosed during pregnancy
Key inclusion criteria (1 listed)
- Patients with breast cancer diagnosed during pregnancy
Key exclusion criteria (1 listed)
- Patients who refuse informed consent
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
Perinatal results
Time frame: Delivery
Gestational age, weight, Apgar, blood tests
1 secondary outcome
Maternal outcome
Time frame: 5 year and 10 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Results publication: PubMed 23116970Cordoba O, Llurba E, Saura C, Rubio I, Ferrer Q, Cortes J, Xercavins J. Multidisciplinary approach to breast cancer diagnosed during pregnancy: maternal and neonatal outcomes. Breast. 2013 Aug;22(4):515-9. doi: 10.1016/j.breast.2012.10.005. Epub 2012 Oct 30.
- Results publication: PubMed 20968147Cordoba O, Llurba E, Cortes J, Sabadell MD, Lirola JL, Ferrer Q, Xercavins J. Complete pathological remission in a patient with hormone-receptor positive and c-erbB-2 expression-negative breast cancer treated with FAC chemotherapy during pregnancy. Tumori. 2010 Jul-Aug;96(4):629-32. doi: 10.1177/030089161009600420.
Related trials for Pregnancy
RecruitingObservational study
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GYN Disorders
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Recruiting
The Effect of Using Nature Sounds and Virtual Reality During the Non-Stress Test
Pregnancy - Prenatal Testing
RecruitingObservational study
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Non-Muscle Invasive Bladder Cancer
RecruitingPhase 3
A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Ovarian Neoplasms, Fallopian Tube Neoplasms
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.
Octavi Cordoba, PhD MD principal investigator
Hospital Vall d'Hebron
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Breast Cancer, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
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: status not confirmed, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Octavi Cordoba, PhD (34934893184, ocordoba@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal results (time frame: Delivery). 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 NCT02102282, which also lists 2 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 2 Apr 2014.