Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT01334021
Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer
A Phase 2 study testing Biopsy, Conventional Surgery and Genetic Testing in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer. Genetic testing is a procedure that tests tumor samples to learn if certain genes are activated (turned on) in the tumor and if the activation of these genes may… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Biopsy, Conventional Surgery and Genetic Testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2011to 31 Dec 2026
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III; stage IV patients will be allowed and included in the feasibility assessment, but will not be included in outcomes analysis for secondary objectives
- The clinical or radiologic primary tumor size is at least 1 cm diameter
Who cannot join
- The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining
- The patient has received prior systemic therapy or radiation therapy for breast cancer
- The patient has a prior history of invasive or metastatic cancer within 5 years of diagnosis of breast cancer, excluding squamous cell or basal cell carcinoma of the skin
- The patient had prior excisional biopsy of the primary invasive breast cancer
- There is hematoma or biopsy site changes that obscure the primary tumor
- Patients deemed medically ineligible for any adjuvant or neoadjuvant therapy. Patients with ER-positive (+) tumors deemed medically eligible for hormonal therapy, but not chemotherapy will be considered eligible for this protocol. Patients with ER-negative (-) tumors who are not candidates for adjuvant anthracycline based chemotherapy will be considered ineligible for this protocol. Patients who undergo biopsy and are later found to be ineligible for adjuvant therapy will be assessed for the primary objective, but will be excluded from the secondary objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Validation and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III)
This phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer. Genetic testing is a procedure that tests tumor samples to learn if certain genes are activated (turned on) in the tumor and if the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of implementation of molecular (genomic) predictive testing for patients with localized (stage I-III) invasive carcinoma of the breast who are candidates for either adjuvant or neoadjuvant treatment of their breast cancer.
SECONDARY OBJECTIVES:
- Estimate the frequency of tumors in each of the four molecularly defined cohorts, overall and within subsets defined by nodal status and estrogen receptor (ER) status.
II. Estimate the concordance of genomic analysis of gene expression levels for ER and HER2 from the microarray (published previously), compared with standard testing with immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to determine ER and HER2 status in these tumors.
III. Estimate the rates of indeterminate results and other variables of feasibility for tissue obtained by different procurement methods including: fine needle aspiration, core needle biopsy or surgical resection.
IV. Estimate the impact of adjuvant therapy as measured by disease free survival (DFS) at 3 and 5 years for the patients within each cohort who received a neoadjuvant or adjuvant treatment that is concordant with the application of the prediction result (i.e. chemotherapy [CT] with sequential taxane and anthracycline regimens +/- subsequent endocrine therapy [ET] if hormone receptor-positive) as follows: Group A: ET alone (without CT); Group B: CT followed by ET; Group C: CT alone; Group D: CT, followed by ET if hormone receptor positive.
- Estimate the impact of neoadjuvant therapy for patients within each cohort, as measured by pathologic response in the breast and regional lymph nodes (pathologic complete response rate [pCR] and residual cancer burden [RCB]).
VI. Estimate the predictive performance of other pre-validated and published genomic predictors of chemotherapy or endocrine therapy sensitivity by calculating those predictions from the microarray data that are produced or by using available results if the test was performed separately for clinical use.
VII. Determine molecular characteristics of residual disease by analyzing resected surgical specimens of residual disease in patients who have received neoadjuvant chemotherapy.
VIII. Determine molecular characteristics of recurrent or metastatic disease by analyzing tumor tissue obtained from diagnostic biopsies of a recurrent or metastatic tumor and comparing these samples to the primary tumor.
OUTLINE:
Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results.
After completion of study, patients are followed up for 5 years.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Biopsy, Conventional Surgery, Genetic Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo tumor biopsy
Conventional SurgeryProcedure or surgery
Undergo surgery
Genetic TestingOther
Also called genetic analysis, Genetic Examination, Genetic Test
Undergo genetic testing
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (biopsy, surgery, genetic testing) | Experimental | Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results. Receives: Procedure: Biopsy; Procedure: Conventional Surgery; Other: Genetic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility defined as the ability to classify patients into 1 of 4 cohorts
The study will use the methods of Thall et al. to monitor the ability to classify patients into 1 of 4 groups (success rate) throughout the trial. Will use summary statistics to describe the demographic and clinical characteristics of patients overall and within each subgroup (Groups A-D).
Measured: Up to 5 years
Secondary outcomes (4)
Disease-free survival (DFS)
The study will estimate 3-year DFS with 95% confidence intervals within each subgroup (Groups A-D) using the Kaplan-Meier estimator. Will also use a Cox proportional hazards regression model to estimate the association between DFS and subgroup, genomic predictions of treatment response, treatment, age at diagnosis, tumor stage at diagnosis, clinical nodal status at diagnosis, and histologic grade.
Measured: Time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years
Frequency of tumors
The study will estimate the relative frequency of tumors classified within each prediction cohort (groups A-D) with 95% confidence intervals.
Measured: Up to 5 years
Concordance of genomic analysis with immunohistochemistry (IHC)
The study will tabulate the estrogen receptor (ER) status and Her2 status of tumors as determined by the genomic analysis and by IHC. Will estimate the concordance between these 2 methods for ER status and for Her2 status with 95% confidence intervals.
Measured: Up to 5 years
Indeterminate Results
The study will use descriptive statistics to summarize the data in an effort to understand reasons for obtaining indeterminate results when trying to classify patients into 1 of the 4 subgroups (Groups A-D). Will summarize these data overall and separately for each biopsy method (e.g., fine needle aspiration, core needle biopsy, surgical resection).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study start31 May 2011
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Senthilkumar Damodaran, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334021
- Sponsor's protocol ID
- 2011-0007
- Other IDs
- NCI-2018-02476, 2011-0007
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2011
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Validation and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III)
- ClinicalTrials.gov ID
- NCT01334021
- Acronym / sponsor ID
- 2011-0007
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 May 2011 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Apr 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 phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer. Genetic testing is a procedure that tests tumor samples to learn if certain genes are activated (turned on) in the tumor and if the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.
Detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of implementation of molecular (genomic) predictive testing for patients with localized (stage I-III) invasive carcinoma of the breast who are candidates for either adjuvant or neoadjuvant treatment of their breast cancer.
SECONDARY OBJECTIVES:
- Estimate the frequency of tumors in each of the four molecularly defined cohorts, overall and within subsets defined by nodal status and estrogen receptor (ER) status.
II. Estimate the concordance of genomic analysis of gene expression levels for ER and HER2 from the microarray (published previously), compared with standard testing with immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to determine ER and HER2 status in these tumors.
III. Estimate the rates of indeterminate results and other variables of feasibility for tissue obtained by different procurement methods including: fine needle aspiration, core needle biopsy or surgical resection.
IV. Estimate the impact of adjuvant therapy as measured by disease free survival (DFS) at 3 and 5 years for the patients within each cohort who received a neoadjuvant or adjuvant treatment that is concordant with the application of the prediction result (i.e. chemotherapy [CT] with sequential taxane and anthracycline regimens +/- subsequent endocrine therapy [ET] if hormone receptor-positive) as follows: Group A: ET alone (without CT); Group B: CT followed by ET; Group C: CT alone; Group D: CT, followed by ET if hormone receptor positive.
- Estimate the impact of neoadjuvant therapy for patients within each cohort, as measured by pathologic response in the breast and regional lymph nodes (pathologic complete response rate [pCR] and residual cancer burden [RCB]).
VI. Estimate the predictive performance of other pre-validated and published genomic predictors of chemotherapy or endocrine therapy sensitivity by calculating those predictions from the microarray data that are produced or by using available results if the test was performed separately for clinical use.
VII. Determine molecular characteristics of residual disease by analyzing resected surgical specimens of residual disease in patients who have received neoadjuvant chemotherapy.
VIII. Determine molecular characteristics of recurrent or metastatic disease by analyzing tumor tissue obtained from diagnostic biopsies of a recurrent or metastatic tumor and comparing these samples to the primary tumor.
OUTLINE:
Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results.
After completion of study, patients are followed up for 5 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (biopsy, surgery, genetic testing) | Experimental | Procedure: Biopsy, Procedure: Conventional Surgery, Other: Genetic TestingPatients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III; stage IV patients will be allowed and included in the feasibility assessment, but will not be included in outcomes analysis for secondary objectives
- The clinical or radiologic primary tumor size is at least 1 cm diameter
Key exclusion criteria (6 listed)
- The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining
- The patient has received prior systemic therapy or radiation therapy for breast cancer
- The patient has a prior history of invasive or metastatic cancer within 5 years of diagnosis of breast cancer, excluding squamous cell or basal cell carcinoma of the skin
- The patient had prior excisional biopsy of the primary invasive breast cancer
- There is hematoma or biopsy site changes that obscure the primary tumor
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 |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo tumor biopsy | Procedure or surgery | Diagnostic (biopsy, surgery, genetic testing) |
| Conventional SurgeryUndergo surgery | Procedure or surgery | Diagnostic (biopsy, surgery, genetic testing) |
| Genetic TestingAlso: genetic analysis, Genetic Examination, Genetic TestUndergo genetic testing | Other | Diagnostic (biopsy, surgery, genetic testing) |
Primary outcome
Feasibility defined as the ability to classify patients into 1 of 4 cohorts
Time frame: Up to 5 years
The study will use the methods of Thall et al. to monitor the ability to classify patients into 1 of 4 groups (success rate) throughout the trial. Will use summary statistics to describe the demographic and clinical characteristics of patients overall and within each subgroup (Groups A-D).
4 secondary outcomes
Disease-free survival (DFS)
Time frame: Time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years
Frequency of tumors
Time frame: Up to 5 years
Concordance of genomic analysis with immunohistochemistry (IHC)
Time frame: Up to 5 years
Indeterminate Results
Time frame: Up to 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 18 Sep 2026.
- MD Anderson Cancer Center WebsiteLink 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.
Senthilkumar Damodaran principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biopsy, Conventional Surgery and Genetic Testing in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
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 2 inclusion and 6 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility defined as the ability to classify patients into 1 of 4 cohorts (time frame: Up to 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 18 Sep 2026.