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The study of the safety and efficacy of palbociclib combined with anlotinib in the treatment of CDK4/6 inhibitor-resistant HR+ breast cancer

The study of the safety and efficacy of palbociclib combined with anlotinib in the treatment of CDK4/6 inhibitor-resistant HR+ breast cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092967
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Intervention Group:The patient received palbociclib (125 mg/d, qd, d1-d21,28d/cycle)
anlotinib (12 mg/d, qd, d1-d14,21d/cycle)

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or pathologically confirmed HR+, HER2- advanced breast cancer. 2. Age =18 years old and =75 years old. 3.ECOG physical status score 0-2. 4. Expected survival period =3 months. 5. Have not received anlotinib treatment in the past. 6. Have received a CDK4/6i treatment (other than palbociclib) in the past, and the disease has progressed. 7. At least one measurable objective lesion (extraskeletal) according to RECIST 1.1 criteria

Exclusion criteria

Exclusion criteria: 1. Have received palbociclib or anlotinib treatment in the past; 2. Those who are known to have a history of allergies to the drug components of this regimen; have a history of immunodeficiency, including positive HIV testing, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 3. Any known liver disease, including infectious diseases with active infection, autoimmune liver disease and sclerosing cholangitis; 4. Pregnant, lactating female patients or patients planning to become pregnant during the study; 5. Have serious heart disease; 6. Have a history of other malignant tumors (except those that have been cured); 7. Other circumstances in which the researcher deems it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival;Objective response rate;

Secondary

MeasureTime frame
Overall survival;Disease control rate;Duration of remission;Safety and Tolerability;

Countries

China

Contacts

Public ContactHou Lingmi

Affiliated Hospital of North Sichuan Medical College

houlingmi@163.com+86 138 9079 8808

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026