NCT01334021Active, not recruitingPhase 2
Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer
Feasibility, Validation and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III)
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1100 (estimated)
- First submitted
- 8 Apr 2011
- Start date
- 31 May 2011
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT01334021
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 1100
- From 31 May 2011 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient has received prior systemic therapy or radiation therapy for breast cancer
- The patient had prior excisional biopsy of the primary invasive breast cancer
- 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
Other illness
- 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 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
Other
- There is hematoma or biopsy site changes that obscure the primary tumor
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.