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Efficacy, tolerability, and safety of palbociclib combined with an aromatase inhibitor in hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer: a multi-center parallel-group randomized controlled trial

Efficacy, tolerability, and safety of palbociclib combined with an aromatase inhibitor in hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer: a multi-center parallel-group randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024998
Enrollment
Unknown
Registered
2019-08-07
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Breast Cancer

Interventions

palbociclib + letrozole group:palbociclib + letrozole
letrozole alone group:letrozole alone

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 Patients with histological and imaging findings-confirmed hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer; 2 postmenopausal patients; 3 eligible patients receiving one or more treatment strategies who are followed-up in the center where they receive treatment; 4 provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1 Aged < 18 years; 2 pregnant woman 3 participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;—

Secondary

MeasureTime frame
Overall survival;Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B);EuroQol five-dimension scale (ED-5Q);—

Countries

China

Contacts

Public ContactCaigang Liu

Shengjing Hospital of China Medical University

liucg@sj-hospital.org+86 18940254967

Outcome results

None listed

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