Breast CancerNCT00903591
Study of Radiation Exposure and Bilateral Breast Cancer
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in 3 countries.
Trial summary
This study is being done to find out what factors may be related to the risk of getting a second breast cancer among women who already have breast cancer in one breast. It will look at how genes, treatment for breast cancer; including radiation therapy, and the effects of different lifestyle activities, may affect the… Read more about this study
- Who is it for?
- Ages 18 to 54 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- questionaire, blood or saliva sample
- How many people
- 1,699 participants
- Where
- 6 sitesin 3 countries
- Study dates
- May 2009to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 54 years
- Women only
- No healthy volunteers
- Adult
Study population: All of the WECARE:GWA Study participants (new cases and individually matched controls) will be identified, recruited, and interviewed by investigative teams in the five population-based cancer registries (NCC, OCR, FHCRC, Iowa, and DCS).
Who may be able to join
- Eligibility for Cases: All women who meet the following eligibility requirements will be recruited as cases for the WECARE:GWA Study if they are not already cases (or refusers) from the parent WECARE Study:
- Diagnosed since 1/1/1990 with a histologically confirmed first primary breast cancer (only invasive stage 1 or 2) while residing in one of the study enrollment site (cancer registry);
- Diagnosed since 1/1/1992 with CBC (invasive only any stage) while residing in the same enrollment site (cancer registry);
- Two years or longer time interval between first and second primaries; Between the ages of 18 and 54 at the time of diagnosis of the first primary;
- Alive at time of contact; and
- No history of previous or intervening cancer diagnosis, except cervical cancer in situ (CIS) or non-melanoma skin cancer.
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- Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast following diagnosis of their first primary.
- Eligibility for Controls: Women who meet all of the following requirements will be eligible as controls. One matched control will be recruited for each participating case:
- Diagnosed since 1/1/1990 with their first primary breast cancer (only invasive stage 1 or 2) while residing in one of the study enrollment site (i.e., cancer registry);
- Between the ages of 18 and 54 at the time of diagnosis of the first primary;
- Residing in the same study enrollment site (cancer registry) as when they were diagnosed with their breast cancer;
- Alive at time of contact;
- Never diagnosed (at reference date (date of first diagnosis plus "at risk interval" of matched case)) as having had CBC or any other cancer diagnosis other than the original breast cancer; with the exception of CIS or non-melanoma skin cancer.
- Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast following diagnosis of their first primary.
- Matching of Controls: Controls eligible for inclusion in this study will be individually matched (1:1) to cases on:
- Enrollment site (cancer registry);
- Age at diagnosis of the cases first primary(within 5-year age groups);
- Year of diagnosis of the cases first primary;(within 4-year categories);
- Race/ethnicity (white, black, Latina, Asian, other).
Who cannot join
- Exclusion for Cases: Women with any of the following characteristics will be ineligible as a case:
- Unable to speak English in U.S. or Canadian enrolling sites or Spanish in the California site, and Danish in Denmark
- Unable to sign informed consent
- Stage IV distant metastases for either the first or second primary (lymph node metastasis is acceptable, but there should be no organ involvement
- Simultaneous diagnosis of invasive in one breast and in situ in the other breast
- Exclusion for Controls: Women with any of the following characteristics will be ineligible as a control:
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- Unable to speak English in U.S. and Canadian enrolling sites, or Spanish in the California site and Danish in Demark
- Unable to sign informed consent
- Stage IV distant metastases (lymph node metastasis is acceptable, but there should be no organ involvement
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
University of Iowa
Iowa City, Iowa, 52242
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Stanford University
Stanford, California, 94305
Canada1 site
ONTARIO CANCER REGISTRY, Mount Sinai Hospital, Toronto
Toronto, Ontario, M5G 1X5
About this study
Official title: Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer
This study is being done to find out what factors may be related to the risk of getting a second breast cancer among women who already have breast cancer in one breast. It will look at how genes, treatment for breast cancer; including radiation therapy, and the effects of different lifestyle activities, may affect the risk of breast cancer. It will use different processes to find genes that might increase the risk of breast cancer. The results of this study may help to develop better ways to detect, treat and prevent breast cancer. This study will compare women who have breast cancer in both breasts to women who have breast cancer in only one breast.
Read the detailed description
This study expands upon an existing case-control study we call the Women's Environment Cancer and Radiation Epidemiology (WECARE) Study. For simplicity, in this protocol, we will refer to that study as the "parent" study. The goal of both studies is to examine the interaction of radiation exposure and genetic susceptibility factors in the etiology of breast cancer. A subset of study participants who consented to 'future contact' in the GWA Study (and those in the 'parent' study from selected sites) will be included in an analysis of radiation-related heart disease and related conditions.
- Conditions
- Breast Cancer
- Being tested
- questionaire, blood or saliva sample
- Keywords
- Breast, cancer, 09-040, blood sample, saliva sample, WECARE, GWA
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaire, blood or saliva sampleOther
Also called The women who consented to 'future contact' in the WECARE:GWAS Study will be, identified, approached, and interviewed by investigative teams in the five data collection sites, (CPIC, MSHT, FHCRC, Iowa, and DCS) over approximately 8 months. Across all data, collection sites, we will approach all eligible cases and controls who consented to future contact
Take part in an approximately 45 minute telephone interview, with questions about detailed treatment (chemotherapy, hormonal therapy, radiation therapy (RT)) for all study participants. Their medical records will be reviewed to get further details about treatment of their breast cancer. They donate either a 35 ml blood sample (about 3 tablespoons) or a saliva sample. Blood Sample: if patient consents to give a blood sample, following the interview, they will be contacted by our staff phlebotomist (a person trained to draw blood). A scheduled appointment to draw a blood sample from you at your home. At the time of the blood draw, the phlebotomist will collect approximately 2 and 1/3 tablespoons of blood. Saliva Sample: if they choose not to give a blood sample, but consent to give a saliva sample instead, a saliva kit will be sent to there home. Once they provide the sample in the kit, they will be asked to mail back the sample in the pre-labeled kit that was sent to them.
| Study group | Role | What they receive |
|---|---|---|
| 1 | All women will be interviewed by telephone using the a similar questionnaire as used in the parent study. DNA samples will be obtained either via blood samples drawn during a home or clinic visits, or an Oragene Saliva DNA Self-Collection Kit sent to the participant's home. Receives: Other: questionaire, blood or saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study.
Measured: 2.5 years
Secondary outcomes (3)
Identify single nucleotide polymorphism that interact with radiation exposure.
Measured: 2.5 years
Replication. Using the entire WECARE Study population, determine whether genomic regions found to be associated with unilateral breast cancer as identified via independent genome-wide association studies conducted by other research groups.
Measured: 2.5 years
Characterize genomic regions containing variants associated with contralateral breast cancer and/or radiation-induced breast cancer in a population-based nested case-control study design.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
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 Memorial Sloan Kettering Cancer CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Genomics Research Institute, University of Southern California, University of Virginia, Lund University, Ontario Cancer Registry (OCR) and Mount Sinai Hospital- Toronto (MSHT), Northern California Cancer Center, Fred Hutchinson Cancer Center, University of Iowa, Danish Cancer Society, Beckman Research Institute, City of Hope National Medical Center, M.D. Anderson Cancer Center, Vanderbilt University School of Medicine, NYU Langone Health, University of Chicago, University of California, Irvine, Stanford University, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jonine Bernstein, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903591
- Sponsor's protocol ID
- 09-040
- Other IDs
- R01CA129639-01A2
- Status last verified
- Jun 2026
- First submitted
- 15 May 2009
- Last updated
- 3 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer
- ClinicalTrials.gov ID
- NCT00903591
- Acronym / sponsor ID
- 09-040
- Conditions
- Breast Cancer
- Keywords
- Breast, cancer, 09-040, blood sample, saliva sample, WECARE, GWA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,699 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Translational Genomics Research Institute, University of Southern California, University of Virginia, Lund University, Ontario Cancer Registry (OCR) and Mount Sinai Hospital- Toronto (MSHT), Northern California Cancer Center, Fred Hutchinson Cancer Center, University of Iowa, Danish Cancer Society, Beckman Research Institute, City of Hope National Medical Center, M.D. Anderson Cancer Center, Vanderbilt University School of Medicine, NYU Langone Health, University of Chicago, University of California, Irvine, Stanford University, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- May 2009 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 May 2009 (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 study is being done to find out what factors may be related to the risk of getting a second breast cancer among women who already have breast cancer in one breast. It will look at how genes, treatment for breast cancer; including radiation therapy, and the effects of different lifestyle activities, may affect the risk of breast cancer. It will use different processes to find genes that might increase the risk of breast cancer. The results of this study may help to develop better ways to detect, treat and prevent breast cancer. This study will compare women who have breast cancer in both breasts to women who have breast cancer in only one breast.
Detailed description
This study expands upon an existing case-control study we call the Women's Environment Cancer and Radiation Epidemiology (WECARE) Study. For simplicity, in this protocol, we will refer to that study as the "parent" study. The goal of both studies is to examine the interaction of radiation exposure and genetic susceptibility factors in the etiology of breast cancer. A subset of study participants who consented to 'future contact' in the GWA Study (and those in the 'parent' study from selected sites) will be included in an analysis of radiation-related heart disease and related conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: questionaire, blood or saliva sampleAll women will be interviewed by telephone using the a similar questionnaire as used in the parent study. DNA samples will be obtained either via blood samples drawn during a home or clinic visits, or an Oragene Saliva DNA Self-Collection Kit sent to the participant's home. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All of the WECARE:GWA Study participants (new cases and individually matched controls) will be identified, recruited, and interviewed by investigative teams in the five population-based cancer registries (NCC, OCR, FHCRC, Iowa, and DCS).
Key inclusion criteria (19 listed)
- Eligibility for Cases: All women who meet the following eligibility requirements will be recruited as cases for the WECARE:GWA Study if they are not already cases (or refusers) from the parent WECARE Study:
- Diagnosed since 1/1/1990 with a histologically confirmed first primary breast cancer (only invasive stage 1 or 2) while residing in one of the study enrollment site (cancer registry);
- Diagnosed since 1/1/1992 with CBC (invasive only any stage) while residing in the same enrollment site (cancer registry);
- Two years or longer time interval between first and second primaries; Between the ages of 18 and 54 at the time of diagnosis of the first primary;
- Alive at time of contact; and
Key exclusion criteria (9 listed)
- Exclusion for Cases: Women with any of the following characteristics will be ineligible as a case:
- Unable to speak English in U.S. or Canadian enrolling sites or Spanish in the California site, and Danish in Denmark
- Unable to sign informed consent
- Stage IV distant metastases for either the first or second primary (lymph node metastasis is acceptable, but there should be no organ involvement
- Simultaneous diagnosis of invasive in one breast and in situ in the other breast
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 |
|---|---|---|
| questionaire, blood or saliva sampleAlso: The women who consented to 'future contact' in the WECARE:GWAS Study will be, identified, approached, and interviewed by investigative teams in the five data collection sites, (CPIC, MSHT, FHCRC, Iowa, and DCS) over approximately 8 months. Across all data, collection sites, we will approach all eligible cases and controls who consented to future contactTake part in an approximately 45 minute telephone interview, with questions about detailed treatment (chemotherapy, hormonal therapy, radiation therapy (RT)) for all study participants. Their medical records will be reviewed to get further details about treatment of their breast cancer. They donate either a 35 ml blood sample (about 3 tablespoons) or a saliva sample. Blood Sample: if patient consents to give a blood sample, following the interview, they will be contacted by our staff phlebotomist (a person trained to draw blood). A scheduled appointment to draw a blood sample from you at your home. At the time of the blood draw, the phlebotomist will collect approximately 2 and 1/3 tablespoons of blood. Saliva Sample: if they choose not to give a blood sample, but consent to give a saliva sample instead, a saliva kit will be sent to there home. Once they provide the sample in the kit, they will be asked to mail back the sample in the pre-labeled kit that was sent to them. | Other | 1 |
Primary outcome
Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study.
Time frame: 2.5 years
3 secondary outcomes
Identify single nucleotide polymorphism that interact with radiation exposure.
Time frame: 2.5 years
Replication. Using the entire WECARE Study population, determine whether genomic regions found to be associated with unilateral breast cancer as identified via independent genome-wide association studies conducted by other research groups.
Time frame: 2.5 years
Characterize genomic regions containing variants associated with contralateral breast cancer and/or radiation-induced breast cancer in a population-based nested case-control study design.
Time frame: 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Jonine Bernstein, PhD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in 3 countries.
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 19 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study. (time frame: 2.5 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 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.