Breast CancerNCT01346579
Biomarkers in Tissue Samples From Older Women With Breast Cancer
An observational study of Breast Cancer, run by Alliance for Clinical Trials in Oncology.
Trial summary
This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- laboratory biomarker analysis
- How many people
- 505 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jan 2014
- 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: Patients with breast cancer enrolled on Cancer and Leukemia Group B 9343
- Participants with stage I breast cancer (T1N0M0) and estrogen-receptor status positive or unknown
- Patients underwent lumpectomy with negative margins and were clinically node-negative
About this study
Official title: PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer
This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
Read the detailed description
PRIMARY OBJECTIVES:
To assess the relapse free-survival difference between patients with PIK3CA mutated and wild-type (WT) tumors and therefore validate PIK3CA mutation status as an important biomarker in women 70 years or older diagnosed with breast cancer.
OUTLINE:
Previously collected tissue samples are analyzed via mutation analysis of PIK3CA.
- Conditions
- Breast Cancer
- Being tested
- laboratory biomarker analysis
- Keywords
- stage IA breast cancer, stage IB breast cancer, estrogen receptor-positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative sciences
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer-free interval for patients with PIK3CA-mutated tumors
Measured: baseline
Tumor size
Measured: baseline
Estrogen receptor status
Measured: baseline
Lymph node status
Measured: baseline
Treatment group associated with PIK3CA expression
Measured: baseline
Secondary outcomes (2)
Overall survival associated with PIK3CA
Measured: baseline
Breast cancer specific survival associated with PIK3CA expression
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Study closed prematurely.
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 Alliance for Clinical Trials in OncologyThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mary Ellen Moynahan, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346579
- Sponsor's protocol ID
- CALGB-151101
- Other IDs
- CDR0000699810
- Status last verified
- Jul 2016
- First submitted
- 30 Apr 2011
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01346579
- Acronym / sponsor ID
- CALGB-151101
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, estrogen receptor-positive breast cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study closed prematurely.
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 May 2011 (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 research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES:
To assess the relapse free-survival difference between patients with PIK3CA mutated and wild-type (WT) tumors and therefore validate PIK3CA mutation status as an important biomarker in women 70 years or older diagnosed with breast cancer.
OUTLINE:
Previously collected tissue samples are analyzed via mutation analysis of PIK3CA.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with breast cancer enrolled on Cancer and Leukemia Group B 9343
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 |
|---|---|---|
| laboratory biomarker analysisCorrelative sciences | Other | – |
Primary outcome
Breast cancer-free interval for patients with PIK3CA-mutated tumors
Time frame: baseline
Tumor size
Time frame: baseline
Estrogen receptor status
Time frame: baseline
Lymph node status
Time frame: baseline
Treatment group associated with PIK3CA expression
Time frame: baseline
2 secondary outcomes
Overall survival associated with PIK3CA
Time frame: baseline
Breast cancer specific survival associated with PIK3CA expression
Time frame: baseline
Results and safety
The study was stopped early (reason given: Study closed prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
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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.
Mary Ellen Moynahan, MD study chair
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Alliance for Clinical Trials in Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 4 Jul 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?
The study was stopped early (reason given: Study closed prematurely.). 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?
Breast cancer-free interval for patients with PIK3CA-mutated tumors (time frame: baseline). The study lists 5 primary outcomes in all. 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 4 Jul 2016.