A Prospective, Multi-center Real-world Study to Evaluate the Efficacy and Safety of Palbociclib or Abemaciclib in Combination With Endocrine Treatment(ET) in Patients with HR+HER2- Locally Advanced or Metastatic Breast Cancer

A Prospective, Multi-center Real-world Study to Evaluate the Efficacy and Safety of Palbociclib or Abemaciclib in Combination With Endocrine Treatment in Patients with HR+HER2- Locally Advanced or Metastatic Breast Cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200057393

Enrollment

Unknown

Registered

2022-03-10

Start date

2022-03-01

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Breast Cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female aged 18 years or older. 2. Pathological examination confirmed HR-positive, HER2-negative breast cancer patients with local recurrence or metastasis evidence. 3. Received one of the following regimens for ABC:(Premenopausal patients requiring surgical or OFS medical castration) (1) Palbociclib + ET or (2) Abemaciclib + ET 4. Intend to participate in study process and to follow the study procedure and sign informed consen1.

Exclusion criteria

Exclusion criteria: 1. Female patients during pregnancy or lactation. 2. History of other cancers, except cervical carcinoma in situ, basal cell carcinoma of the skin,or squamous cell carcinoma of the skin, which have received radical treatment in the past.

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS);	—

Secondary

Measure	Time frame
Time to Failure (TTF);Overall Survival (OS);Objective Response Rate (ORR);Disease Control Rate (DCR);Clinical Benefit Rate (CBR) ;Safety;	—

Countries

China

Contacts

Public ContactMan Li

The Second Affiliated Hospital of Dalian Medical University

liman126126@163.com17709873580

Outcome results