Breast CancerNCT01424865
Cancer Stem Cell Biomarkers as a Predictor of Response to Trastuzumab in Samples From Patients With Breast Cancer Previously Treated in the NSABP-B-31 Trial
An observational study of Breast Cancer, run by NSABP Foundation Inc.
Trial summary
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- fluorescence in situ hybridization, immunohistochemistry staining method and immunologic technique
- How many people
- 1,874 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Dec 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: Primary cancer tissue from participants in protocol NSABP B-31.
DISEASE CHARACTERISTICS:
- Tissue samples from patients with node-positive breast cancer whose tumors overexpress HER2
- Primary tumor samples that are negative for HER2 using classically accepted cutoffs determined in the metastatic setting
- Treated with adjuvant therapy comprising doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in the NSABP-B-31 trial
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Evaluation of the Co-Expression of the Cancer Stem Cell Marker ALDH1 and of HER2 as a Predictor of Adjuvant Trastuzumab Response in Breast Cancers of Women in NSABP B31
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in samples from patients with breast cancer previously treated in the NSABP-B-31 trial.
Read the detailed description
OBJECTIVES:
Primary
- To determine if stem cellness identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with either adjuvant doxorubicin hydrochloride \& cyclophosphamide followed by paclitaxel (the "control arm" of B31), or the same chemotherapy plus trastuzumab.
Secondary
- To conduct exploratory analyses to assess, to the extent possible, if co-localization of stem cellness, as determined by ALDH1 positivity, and HER2 identifies a group of patients previously considered to have HER2-negative cancers (using classical definitions) who benefit from adjuvant trastuzumab.
OUTLINE: Archived breast cancer stem cells samples and terminally differentiated cells from tissue samples are analyzed for HER2 and ALDH1 expression by dual-staining quantitative immunofluorescence using Automated Quantitative Analysis (AQUA) , IHC, and fluorescence in situ hybridization (FISH).
- Conditions
- Breast Cancer
- Being tested
- fluorescence in situ hybridization, immunohistochemistry staining method, immunologic technique, laboratory biomarker analysis
- Keywords
- HER2-positive breast cancer, stage II breast cancer, stage IIIA 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.
fluorescence in situ hybridizationGenetic
immunologic techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining
Measured: approximately 4 years
Secondary outcomes (1)
HER2 expression in cells with stem cell-like properties as a determinant of aggressiveness and response to trastuzumab in the adjuvant setting
Measured: approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2015 (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.
- 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
- 1,874 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Daniel F. Hayes, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424865
- Sponsor's protocol ID
- NSABP B-31 ICSCA
- Other IDs
- NSABP-B31-ICSC-A
- Status last verified
- May 2015
- First submitted
- 26 Aug 2011
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Co-Expression of the Cancer Stem Cell Marker ALDH1 and of HER2 as a Predictor of Adjuvant Trastuzumab Response in Breast Cancers of Women in NSABP B31
- ClinicalTrials.gov ID
- NCT01424865
- Acronym / sponsor ID
- NSABP B-31 ICSCA
- Conditions
- Breast Cancer
- Keywords
- HER2-positive breast cancer, stage II breast cancer, stage IIIA breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,874 participants (estimated)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (estimated)
- First posted
- 29 Aug 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.
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in samples from patients with breast cancer previously treated in the NSABP-B-31 trial.
Detailed description
OBJECTIVES:
Primary
- To determine if stem cellness identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with either adjuvant doxorubicin hydrochloride \& cyclophosphamide followed by paclitaxel (the "control arm" of B31), or the same chemotherapy plus trastuzumab.
Secondary
- To conduct exploratory analyses to assess, to the extent possible, if co-localization of stem cellness, as determined by ALDH1 positivity, and HER2 identifies a group of patients previously considered to have HER2-negative cancers (using classical definitions) who benefit from adjuvant trastuzumab.
OUTLINE: Archived breast cancer stem cells samples and terminally differentiated cells from tissue samples are analyzed for HER2 and ALDH1 expression by dual-staining quantitative immunofluorescence using Automated Quantitative Analysis (AQUA) , IHC, and fluorescence in situ hybridization (FISH).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary cancer tissue from participants in protocol NSABP B-31.
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 |
|---|---|---|
| fluorescence in situ hybridization | Genetic | – |
| immunohistochemistry staining method | Other | – |
| immunologic technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining
Time frame: approximately 4 years
1 secondary outcome
HER2 expression in cells with stem cell-like properties as a determinant of aggressiveness and response to trastuzumab in the adjuvant setting
Time frame: approximately 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Daniel F. Hayes, MD principal investigator
University of Michigan Rogel Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by NSABP Foundation Inc.
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: status not confirmed, as of the sponsor's last update on 8 May 2015. 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?
ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining (time frame: approximately 4 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 8 May 2015.