Can adding a hormone pill to chemotherapy shrink breast tumors better before surgery?
NCT ID NCT07801898
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This phase II trial tests whether combining the hormone therapy letrozole with standard chemotherapy before surgery can improve tumor shrinkage in people with ER-positive, HER2-negative breast cancer that grows quickly. Participants receive either six cycles of docetaxel, epirubicin, and cyclophosphamide or a sequential regimen of epirubicin plus cyclophosphamide followed by a taxane, along with daily letrozole. Premenopausal women also receive a drug to suppress ovarian function. The study measures how many tumors shrink or disappear, changes in the Ki-67 growth marker, and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- letrozole combined with standard chemotherapy (docetaxel, epirubicin, cyclophosphamide, or paclitaxel)
- What this could lead to
- If it works, this could point toward a more effective pre-surgery treatment for a common type of breast cancer, potentially shrinking tumors more and improving long-term outcomes.
- What could go wrong
- This is a small, early-phase trial with only 36 participants, so results may not apply broadly. Adding endocrine therapy to chemotherapy could increase side effects without improving response.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
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 to 18 years
- Sex
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Anyone
- 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: * Eligible patients were aged ≥18 years * Histologically confirmed estrogen ER-positive, HER2-negative breast cancer with a Ki67 proliferation index \>20%. * ER-positivity was defined as nuclear staining in ≥1% of tumor cells by immunohistochemistry (IHC). HER2-negative disease was defined as an IHC score of 0 or 1+, or an IHC score of 2+ with negative fluorescence in situ hybridization(FISH). * Patients were required to have stage I-III operable or locally advanced breast cancer according to the eighth edition of the American Joint Committee on Cancer staging system. * Patients with clinically node-negative disease (cN0) were additionally required to have high-risk clinical features, including a primary tumor classified as cT2 or higher and/or a markedly elevated Ki67 proliferation index. * Other inclusion criteria were the presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, adequate bone marrow and major organ function, and no previous systemic chemotherapy or endocrine therapy for breast cancer. Exclusion Criteria: * Previous chemotherapy or endocrine therapy for breast cancer; * Pregnancy or lactation; * Severe or uncontrolled infection; * Clinically significant cardiovascular disease, including New York Heart Association class III or IV heart failure, unstable angina, or myocardial infarction within 6 months before enrollment; * Left ventricular ejection fraction \<50%; * A history of organ transplantation requiring ongoing immunosuppressive therapy; * Known human immunodeficiency virus infection; * A concurrent or previous malignancy that could interfere with the assessment of study outcomes; * Psychiatric, cognitive, or other medical conditions that could impair treatment adherence or compliance with study procedures.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
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