Could a pill replace chemo for some breast cancer patients?
NCT ID NCT07432178
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a chemotherapy-free treatment using the targeted drug Dalpiciclib (a CDK4/6 inhibitor) plus hormone therapy works as well as standard chemotherapy for women with small, high-risk, hormone-receptor-positive breast cancer. About 2,288 participants will be randomly assigned to either the new drug combo or standard chemo, both followed by hormone therapy. The goal is to see if the new approach can prevent cancer from coming back while avoiding chemotherapy's harsh side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 2,288 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2034
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 70 years
- 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: 1. Female, aged 18 to 70 years. 2. Histologically confirmed early breast cancer with pathological stage T1N0, 0.5 cm \< tumor size ≤ 2 cm, ER-positive/HER2-negative, with ER expression ≥ 50%; and willingness to receive adjuvant dalpiciclib treatment. 3. Presence of at least one of the following high-risk features: Ki-67 index ≥ 50%; Grade 3 (G3) tumor; an indication for chemotherapy based on results from multigene assays, including the 21-gene recurrence score and the 70-gene signature ; Age ≤ 40 years. 4. ECOG performance status: 0 to 1. 5. Adequate organ function, defined as meeting the following criteria: Hematology (no blood transfusion within 14 days): Hemoglobin (HB) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet (PLT) ≥ 100 × 10⁹/L. Biochemistry: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN; Serum Creatinine (Cr) ≤ 1 × ULN, with creatinine clearance \> 50 mL/min (calculated using the Cockcroft-Gault formula). 6. Voluntary participation with written informed consent, good compliance, and willingness to comply with follow-up requirements. Exclusion Criteria: 1. Patients who have received neoadjuvant therapy, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy. 2. Bilateral breast cancer. 3. History of other prior malignancies, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix. 4\) Evidence of metastasis at any site. 5) Any T4 lesion (UICC 1987), including skin involvement, tumor fixation/mass, or inflammatory breast cancer. 6\) Pregnant or lactating women, or women of childbearing potential who are unwilling to use adequate contraception. 7\) Concurrent participation in another clinical trial. 8) Severe organ dysfunction (cardiac, pulmonary, hepatic, or renal). Left Ventricular Ejection Fraction (LVEF) \< 50% (by echocardiography). History of severe cardiovascular or cerebrovascular disease within 6 months prior to randomization (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90 mmHg, myocardial infarction, or cerebrovascular accident). Patients with poorly controlled diabetes mellitus or severe hypertension. 9\) Known hypersensitivity to taxanes or their excipients. 10)Severe or uncontrolled infection. 11)History of psychoactive substance abuse that cannot be discontinued, or history of mental disorders. 12)Patients deemed by the investigator to be unsuitable for participation in this study. 13)Patient refusal to receive adjuvant dalpiciclib treatment.
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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
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The official record
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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