Can a cell-cycle blocker boost hormone therapy and stop breast cancer from returning?
NCT ID NCT06637150
First seen Sep 29, 2026 · Last updated Sep 30, 2026 · Updated 1 time
Summary
Researchers are testing whether adding dalpiciclib to standard hormone therapy helps women with early-stage ER-positive, HER2-negative breast cancer that has not spread to lymph nodes but has other risk factors. The trial enrolls about 1,388 women aged 18 to 70 who have had surgery. Participants receive either dalpiciclib plus hormone therapy or hormone therapy alone, and researchers track whether the cancer returns.
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 drug that blocks proteins that help cancer cells divide, added to standard hormone therapy
- What this could lead to
- If adding dalpiciclib works, it could give women with early, node-negative breast cancer a stronger way to lower the chance the cancer comes back.
- What could go wrong
- The trial may find that adding dalpiciclib does not improve outcomes enough to justify its side effects, which can include low blood counts and infections. Results from this trial will not apply to all breast cancers.
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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 1,388 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Sep 2030
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. Women aged 18-70 years 2. ECOG score of 0-1 3. Histologically confirmed unilateral invasive cancer (regardless of pathology type) 4. No macroscopic or microscopic tumor residue after surgical resection 5. Early-stage breast cancer, pathologically confirmed as ER-positive and HER2-negative (ER-positive defined as immunohistochemical detection of ER \>10% of tumor cells positive; HER2 0-1+ or HER2 2+ but FISH negative, with no amplification, defined as HER2-negative) 6. Postoperative pathological staging of pT1c or above, N0M0, and meeting one of the following criteria: (1) G3; (2) G2 and meeting one of the following: i. Ki-67 ≥20%; ii. 21-gene recurrence score ≥26 or high genomic risk profile; iii. Age ≤40 years and vascular invasion positive 7. No prior neoadjuvant treatment 8. Time from surgery or completion of chemotherapy or radiotherapy (whichever occurs later) to randomization does not exceed 8 weeks 9. Good postoperative recovery, at least 1 week after surgery 10. Normal function of major organs, meeting the following criteria: (1) Hematological criteria: HB ≥90 g/L (no blood transfusion in the last 14 days); ANC ≥1.5 × 10\^9 /L; PLT ≥100 × 10\^9 /L; (2) Biochemical criteria: TBIL ≤1.5 × ULN (upper limit of normal); ALT and AST ≤3 × ULN; serum Cr ≤1.5 × ULN 11. Women of childbearing age must use contraception during treatment 12. Subjects voluntarily join this study, sign informed consent, demonstrate good compliance, and cooperate with follow-up Exclusion Criteria: 1. Bilateral breast cancer or ductal/lobular carcinoma in situ (DCIS/LCIS) 2. Received treatment for advanced disease 3. Metastasis at any site 4. Any tumor \> T4a (with skin involvement, fixation, inflammatory breast cancer) 5. Clinically or radiologically suspected malignancy in the contralateral breast not confirmed and requiring biopsy 6. Received neoadjuvant therapy, including chemotherapy, radiotherapy, and endocrine therapy 7. History of malignant tumors within the past 5 years (excluding basal cell carcinoma of the skin and cervical carcinoma in situ), including contralateral breast cancer 8. Patient has been enrolled in other clinical trials 9. Patient has severe systemic diseases and/or uncontrolled infections that prevent participation in the study 10. Severe cardiovascular or cerebrovascular diseases within 6 months prior to randomization (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90 mmHg, myocardial infarction, or stroke) 11. Known allergy to relevant medications 12. Women of childbearing age who refuse contraception during treatment and for 8 weeks after treatment completion 13. Pregnant or breastfeeding women 14. Positive pregnancy test before drug administration after joining the trial 15. Individuals with mental illness or cognitive impairment who cannot understand the trial protocol and its side effects, unable to comply with the protocol and follow-up (systematic assessment required prior to enrollment) 16. Individuals without personal freedom and independent civil capacity
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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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breast cancer institute of Fudan University Cancer Hospital, shanghai, shanghai
RECRUITINGShanghai, China
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