Can a cell-cycle blocker boost hormone therapy and stop breast cancer from returning?

NCT ID NCT06637150

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,388 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • breast cancer institute of Fudan University Cancer Hospital, shanghai, shanghai

    RECRUITING

    Shanghai, China

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