Could a pill replace chemo for some breast cancers?
NCT ID NCT06107673
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial compares a daily pill (dalpiciclib) plus hormone therapy against standard chemotherapy for postmenopausal women with a specific type of breast cancer (ER+ HER2-). The goal is to see if the pill combination works as well as chemo but with fewer side effects. About 144 participants will be enrolled across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dalpiciclib (a targeted cancer pill) plus an aromatase inhibitor (hormone therapy)
- What this could lead to
- If successful, this could offer a less toxic, pill-based alternative to chemotherapy for certain postmenopausal breast cancer patients.
- What could go wrong
- This is a small, early phase II trial, so results may not confirm non-inferiority or translate to broader populations. Side effects from the drug combination are still being studied.
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 144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Dec 2028
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 75 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. Sign the informed consent form to participate in the clinical research. 2. Confirmed postmenopausal females diagnosed with invasive breast cancer. 3. Clinical stage T1-3N1M0. 4. Pathological examination confirmed: Strong positive for ER, negative for HER2. HER2 negative: Immunohistochemistry (IHC) suggests HER2 (-, +) or (++) but in situ hybridization (ISH) indicates negative. Strong positive for ER: ER immunohistochemistry test shows 50% or more tumor cells positive. 5. No prior breast cancer-related treatment. 6. No concurrent cardiac diseases, baseline left ventricular ejection fraction (LVEF) ≥ 50%, no significant cardiac diseases (≤ NYHA class I). 7. ECOG score of 0-1, meeting the indications and basic requirements for chemotherapy without major organ dysfunction. 8. Within 1 week prior to enrollment, routine blood tests are essentially normal: Absolute neutrophil count (NEUT#) ≥ 1.5×10\^9 /L; White blood cell count (WBC) ≥ 3.0×10\^9 /L; Platelets ≥ 90×10\^9 /L; Hemoglobin ≥ 90 g/L. 9. Within 1 week prior to enrollment, liver and kidney function tests are essentially normal: Total bilirubin (TBIL) ≤ 1.5× upper limit of normal (ULN); Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤ 2× ULN; Serum creatinine ≤ 1.5× ULN or creatinine clearance rate (Ccr) ≥ 60 ml/min. 10. For women of childbearing age, negative serum or urine pregnancy test results before participation; premenopausal women during the study period should use medically acceptable methods of contraception. 11. Exhibits good compliance. Exclusion Criteria: 1. Pregnant or lactating women, and women of childbearing age who have a positive pregnancy test at baseline and do not agree to use effective contraception during the study. 2. Patients with a known history of severe allergic reactions to any investigational drug components (NCI-CTCAE Grade \> 3) or with any clearly documented drug allergy. 3. Patients with bilateral breast cancer or inflammatory breast cancer. 4. Patients with metastatic (stage IV) breast cancer at initial diagnosis. 5. Patients with a history of congestive heart failure, unstable angina, arrhythmias, or myocardial infarction. 6. Current diagnosis of acute lung conditions, interstitial lung disease, pulmonary fibrosis, acute pulmonary disease, etc. 7. Current diagnosis of severe liver-related diseases such as acute hepatitis, fulminant hepatitis, coagulation factor synthesis disorders. If HBV surface antigen or HBV core antibody are positive, the peripheral blood HBV DNA titer should be \< 1×10\^3 IU/ml for eligibility. 8. Any other serious medical condition or comorbidity that may interfere with participation in the study or may significantly affect the safety of the subject (e.g., active or uncontrolled infections, active or requiring antiviral therapy for liver and bile diseases). 9. Other invasive malignancies (including second primary breast cancer) that may interfere with the evaluation of study endpoints and compliance with the protocol. 10. Patients with a history of prior treatment with chemotherapy, endocrine therapy, or anti-HER2 biologic therapy for breast cancer (excluding diagnostic biopsy for primary breast cancer). 11. Patients who have undergone major surgery within 4 weeks prior or have significant unresolved medical conditions. 12. Patients with non-measurable tumors during treatment. 13. Any other condition that the investigator deems unsuitable for the participation of the subject in the study.
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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 Fourth Hospital of Hebei Medical University
RECRUITINGShijiazhuang, Hebei, 050011, China
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