Breast CancerPhase 3NCT06637150
Dalpicilib-Enhanced vs. Standard Endocrine Therapy in ER+ HER2- Early Breast Cancer
A Phase 3 study testing Dalpicilib and endocrine therapy in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph node-negative patients with risk factors, in order to further optimize the regimen for adjuvant… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dalpicilib and endocrine therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,388 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2025to 30 Sep 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-70 years
- ECOG score of 0-1
- Histologically confirmed unilateral invasive cancer (regardless of pathology type)
- No macroscopic or microscopic tumor residue after surgical resection
- 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)
- 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
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- No prior neoadjuvant treatment
- Time from surgery or completion of chemotherapy or radiotherapy (whichever occurs later) to randomization does not exceed 8 weeks
- Good postoperative recovery, at least 1 week after surgery
- 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
- Women of childbearing age must use contraception during treatment
- Subjects voluntarily join this study, sign informed consent, demonstrate good compliance, and cooperate with follow-up
Who cannot join
- Bilateral breast cancer or ductal/lobular carcinoma in situ (DCIS/LCIS)
- Received treatment for advanced disease
- Metastasis at any site
- Any tumor \> T4a (with skin involvement, fixation, inflammatory breast cancer)
- Clinically or radiologically suspected malignancy in the contralateral breast not confirmed and requiring biopsy
- Received neoadjuvant therapy, including chemotherapy, radiotherapy, and endocrine therapy
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- 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
- Patient has been enrolled in other clinical trials
- Patient has severe systemic diseases and/or uncontrolled infections that prevent participation in the study
- 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)
- Known allergy to relevant medications
- Women of childbearing age who refuse contraception during treatment and for 8 weeks after treatment completion
- Pregnant or breastfeeding women
- Positive pregnancy test before drug administration after joining the trial
- 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)
- Individuals without personal freedom and independent civil capacity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
breast cancer institute of Fudan University Cancer Hospital, shanghai, shanghai
Shanghai
Zhimin Shao, MD, 86-021-641755901105, zhimingshao@fudan.edu.cn
Zhimin Shao, MD
About this study
Official title: A Phase III Randomized Controlled Trial Comparing Dalpicilib-Enhanced Adjuvant Endocrine Therapy With Standard Adjuvant Endocrine Therapy in ER+ HER2- Lymph Node-Negative Early Breast Cancer With Risk Factors
This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph node-negative patients with risk factors, in order to further optimize the regimen for adjuvant endocrine therapy in breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Dalpicilib, endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalpicilibDrug
Dalpicilib 100 mg once daily from day 1 to day 21, every 4 weeks, for a total of 3 years, in combination with endocrine therapy for 5 years.
endocrine therapyDrug
standard endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| standard endocrine therapy | Active comparator | standard endocrine therapy Receives: Drug: endocrine therapy |
| standard endocrine therapy plus dalpicilib | Experimental | standard endocrine therapy plus dalpicilib Receives: Drug: Dalpicilib; Drug: endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease Free Survival
Invasive Disease Free Survival
Measured: From enrollment to 3 years post-treatment
Secondary outcomes (4)
3-Year Disease-Free Survival
Measured: From enrollment to 3 years post-treatment
Overall Survival
Overall Survival
Measured: From enrollment to 3 years post-treatment
safety
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From enrollment to 3 years post-treatment
Patient reported outcomes
Patient-Reported Outcomes (PROs) Assessed by the EORTC QLQ-C30 Questionnaire. Provide a brief description of what aspects of the patient's health or experience the tool will measure (e.g., quality of life, symptom burden, treatment side effects).
Measured: From enrollment to 3 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start9 Jan 2025
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637150
- Sponsor's protocol ID
- SCHBCC-N081
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Trial Comparing Dalpicilib-Enhanced Adjuvant Endocrine Therapy With Standard Adjuvant Endocrine Therapy in ER+ HER2- Lymph Node-Negative Early Breast Cancer With Risk Factors
- ClinicalTrials.gov ID
- NCT06637150
- Acronym / sponsor ID
- SCHBCC-N081
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,388 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph node-negative patients with risk factors, in order to further optimize the regimen for adjuvant endocrine therapy in breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard endocrine therapy | Active comparator | Drug: endocrine therapystandard endocrine therapy |
| standard endocrine therapy plus dalpicilib | Experimental | Drug: Dalpicilib, Drug: endocrine therapystandard endocrine therapy plus dalpicilib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women aged 18-70 years
- ECOG score of 0-1
- Histologically confirmed unilateral invasive cancer (regardless of pathology type)
- No macroscopic or microscopic tumor residue after surgical resection
- 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)
Key exclusion criteria (16 listed)
- Bilateral breast cancer or ductal/lobular carcinoma in situ (DCIS/LCIS)
- Received treatment for advanced disease
- Metastasis at any site
- Any tumor \> T4a (with skin involvement, fixation, inflammatory breast cancer)
- Clinically or radiologically suspected malignancy in the contralateral breast not confirmed and requiring biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DalpicilibDalpicilib 100 mg once daily from day 1 to day 21, every 4 weeks, for a total of 3 years, in combination with endocrine therapy for 5 years. | Drug | standard endocrine therapy plus dalpicilib |
| endocrine therapystandard endocrine therapy | Drug | standard endocrine therapy, standard endocrine therapy plus dalpicilib |
Primary outcome
Invasive Disease Free Survival
Time frame: From enrollment to 3 years post-treatment
Invasive Disease Free Survival
4 secondary outcomes
3-Year Disease-Free Survival
Time frame: From enrollment to 3 years post-treatment
Overall Survival
Time frame: From enrollment to 3 years post-treatment
safety
Time frame: From enrollment to 3 years post-treatment
Patient reported outcomes
Time frame: From enrollment to 3 years post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dalpicilib and endocrine therapy in people with Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao (86-021-64175590, zhimingshao@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Disease Free Survival (time frame: From enrollment to 3 years post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.