Gene test may guide breast cancer therapy choices
NCT ID NCT01334021
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study looks at whether a genetic test on tumor samples can predict how well HER2-negative breast cancer will respond to standard treatments like chemotherapy or hormone therapy. About 1,100 people with stage I-III breast cancer are taking part. The goal is to see if this testing is practical and can help doctors choose the most effective treatment for each person.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 1,100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2011
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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