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NCT07610720RecruitingPhase 2

Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer

Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer

Source: ClinicalTrials.gov · Last updated 28 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
57 (estimated)
First submitted
6 May 2026
Start date
1 Jun 2026
Primary completion date
1 Nov 2028
Lead sponsor
Sun Yat-sen University
NCT number
NCT07610720

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 57
  • From 1 Jun 2026 to the primary completion date, 1 Nov 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently receiving other anti-tumor therapies.

Other illness

  • History of Grade 3 or 4 allergic reaction related to the study drugs.

Other

  • Symptomatic active brain metastases or extensive leptomeningeal metastases.

Who the study is looking for

  • Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
  • Hormone receptor (HR)-positive and HER2-positive.
  • Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.
  • ECOG Performance Status: 0-1.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District
Coordinator of this site? Confirm its status
GuangdongChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.