NCT07610720 Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
| NCT ID | NCT07610720 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Advanced/Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 57 participants in total. It began in 2026-06-01 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.
Eligibility Criteria
Inclusion Criteria: 1. Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer. 2. Hormone receptor (HR)-positive and HER2-positive. 3. Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy. 4. ECOG Performance Status: 0-1. Exclusion Criteria: 1. Symptomatic active brain metastases or extensive leptomeningeal metastases. 2. History of Grade 3 or 4 allergic reaction related to the study drugs. 3. Currently receiving other anti-tumor therapies.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07610720 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Advanced/Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07610720 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07610720 currently recruiting?
Yes, NCT07610720 is actively recruiting participants. Contact the research team at chenmt@sysucc.org.cn for enrollment information.
Where is the NCT07610720 trial being conducted?
This trial is being conducted at Guangdong, China.
Who is sponsoring the NCT07610720 clinical trial?
NCT07610720 is sponsored by Sun Yat-sen University. The trial plans to enroll 57 participants.
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