Breast CancerNCT01503034
Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014
An observational study of Breast Cancer, run by Centre Oscar Lambret at 37 sites in France.
Trial summary
This is a non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 394 participants
- Where
- 37 sitesFrance
- Study dates
- 14 Dec 2010to 28 Sep 2015
- 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: This study being retrospective, we will include all the subjects that meet our inclusion criteria over the period analyzed.
Who may be able to join
- Women aged 18 or over
- Confirmed histological diagnosis of invasive breast cancer
- No known metastasis
- For the cases :
- Patients pregnant at the time of the first diagnosis
- 1st diagnosis between 2000 and 2014
Show all 9Show fewer
- For the controls :
- Patients not pregnant at the time of the first diagnosis
- 1st diagnosis between 2000 and 2009
Who cannot join
- Patients who have undergone an induced abortion after the diagnosis of breast cancer
- Patients with a history of breast cancer
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
France37 sites
Clinique Sainte Catherine
Avignon, 84000
Cabinet Dr Le Guen Naas
Baud, 56150
Centre Hospitalier Universitaire
Besançon, 25030
Institut Bergonié
Bordeaux, 33076
CHR
Brest, 29609
Centre François Baclesse
Caen, 14076
Centre Hospitalier René Dubos
Cergy-Pontoise, 95300
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Léonard de Vinci
Dechy, 59187
Centre Georges François Leclerc
Dijon, 21079
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon, 85925
Centre Oscar Lambret
Lille, 59020
Centre de Pharmacovigilance
Lille, 59045
Centre Hospitalier de Bretagne Sud
Lorient, 56322
Centre Léon Bérard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13273
CHRU La Peyronie et Centre Val d'Aurelle
Montpellier, 34298
Centre Catherine de Sienne
Nantes, 44202
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Paris, 75005
Hôpital Saint-Louis
Paris, 75010
Hôpital Cochin
Paris, 75014
Hôpital Tenon
Paris, 75020
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69310
Institut Jean Godinot
Reims, 51056
Polyclinique de Courlancy
Reims, 51100
Centre Eugene Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
Clinique Radiologique
Saint-Brieuc, 22015
Centre René Huguenin
Saint-Cloud, 92210
Centre René Gauducheau
Saint-Herblain, 44805
Centre Paul Strauss
Strasbourg, 67065
Institut Claudius Régaud
Toulouse, 31052
Cabinet Dr Leroy
Tourcoing, 59200
Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan
Tours, 37000
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Study of Tumor Characteristics, Patient Care and Prognosis of Women With Breast Cancer During a Pregnancy Diagnosed Between 2000 and 2014
This is a non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls).
Read the detailed description
Investigators will explain the purpose of the study to the eligible patients, still alive, and will inform them verbally and in writing, using the information note, of their possibility of refusal. No information will be made for deceased patients.
The investigators will complete the case report forms on paper and then will send them by mail.
- Conditions
- Breast Cancer
- Keywords
- Pregnant women
- 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 |
|---|---|---|
| Study cohort | This cohort is made up of pregnant women with a breast cancer diagnosed between 2000 and 2014. | |
| Compared cohort | This cohort is made up of non-pregnant women with a breast cancer diagnosed between 2000 and 2009. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The overall survival corresponds to the time elapsed between the breast cancer diagnostic date and the death date.
Measured: 5 years
Secondary outcomes (4)
the support of breast cancer cases occured during pregnancy
Description of the anti-tumor treatment (surgery, radiotherapy, chemotherapy, hormone therapy, targeted therapy), of the imaging performed and of the childbirth (programmed or not, vaginal or caesarean section, baby's condition at birth, etc.).
Measured: 5 years
Tumor characteristics
Description of the tumor characteristics on the diagnostic biopsy or on the surgical specimen : histological type, Her2 status, hormone receptor status, etc.
Measured: 5 years
Disease-free survival
The disease-free survival is calculated from the time elapsed between the breast cancer diagnostic date and the first recurrence of the disease.
Measured: 5 years
Case-control comparison
Comparison of the tumoral characteristics, the patient care and the prognosis of women with breast cancer appeared during a pregnancy, with non-pregnant women of the same age.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study start14 Dec 2010
- Primary completion28 Sep 2015
- Study completion28 Sep 2015
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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence VANLEMMENS, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503034
- Sponsor's protocol ID
- Cancer et grossesse
- Status last verified
- Mar 2018
- First submitted
- 30 Dec 2011
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tumor Characteristics, Patient Care and Prognosis of Women With Breast Cancer During a Pregnancy Diagnosed Between 2000 and 2014
- ClinicalTrials.gov ID
- NCT01503034
- Acronym / sponsor ID
- Cancer et grossesse
- Conditions
- Breast Cancer
- Keywords
- Pregnant women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 14 Dec 2010 (actual)
- Primary completion
- 28 Sep 2015 (actual)
- Study completion
- 28 Sep 2015 (actual)
- First posted
- 2 Jan 2012 (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 non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls).
Detailed description
Investigators will explain the purpose of the study to the eligible patients, still alive, and will inform them verbally and in writing, using the information note, of their possibility of refusal. No information will be made for deceased patients.
The investigators will complete the case report forms on paper and then will send them by mail.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | –This cohort is made up of pregnant women with a breast cancer diagnosed between 2000 and 2014. |
| Compared cohort | – | –This cohort is made up of non-pregnant women with a breast cancer diagnosed between 2000 and 2009. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study being retrospective, we will include all the subjects that meet our inclusion criteria over the period analyzed.
Key inclusion criteria (9 listed)
- Women aged 18 or over
- Confirmed histological diagnosis of invasive breast cancer
- No known metastasis
- For the cases :
- For the controls :
Key exclusion criteria (2 listed)
- Patients who have undergone an induced abortion after the diagnosis of breast cancer
- Patients with a history of breast cancer
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
Time frame: 5 years
The overall survival corresponds to the time elapsed between the breast cancer diagnostic date and the death date.
4 secondary outcomes
the support of breast cancer cases occured during pregnancy
Time frame: 5 years
Tumor characteristics
Time frame: 5 years
Disease-free survival
Time frame: 5 years
Case-control comparison
Time frame: 5 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 3 Apr 2018.
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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.
Laurence VANLEMMENS, MD principal investigator
Centre Oscar Lambret
37 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 Centre Oscar Lambret at 37 sites 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 9 inclusion and 2 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 3 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 37 sites 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 (time frame: 5 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 3 Apr 2018.