Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC

Hormone Receptor Positive Advanced Breast Cancer Clinical Trial

— CAPACITY  

Official title:

Comparative Effectiveness of Palbociclib Plus Aromatase Inhibitor Versus Fulvestrant Alone as Initial Endocrine Therapy for HR+/HER2- Advanced Breast Cancer in Chinese Clinical Practice: a Real-world Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000736
• Other study ID #: CH-BC-086
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan, M.D.
• Phone: +8613501270834
• Email: yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib plus AI therapy and fulvestrant monotherapy as initial endocrine therapy in the patients with HR+/HER2- advanced breast cancer.

Description:

This study is designed to be a retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus AI or fulvestrant monotherapy from August 1, 2018 to December 31, 2020. It is expected to enroll 600 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected retrospectively, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Chinese women =18 years old;

2. Diagnosed with locally advanced (stage IIIb/IIIc) or metastatic (stage IV) breast cancer;

3. The molecular classification is pathologically confirmed as HR+/HER2-;

4. Palbociclib plus AI or fulvestrant monotherapy as initial endocrine therapy for advanced breast cancer for at least 1 cycle;

5. The follow-up time should be not less than 3 months after the start of palbociclib plus AI therapy or fulvestrant monotherapy.

Exclusion Criteria:

1. Subjects who have previously received chemotherapy, other CDK4/6 inhibitors or other endocrine monotherapy for advanced breast cancer.

Related Conditions & MeSH terms

• Breast Neoplasms
• Hormone Receptor Positive Advanced Breast Cancer

Intervention

Drug:
• palbociclib + aromatase inhibitor
palbociclib + aromatase inhibitor therapy
• fulvestrant
fulvestrant monotherapy

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-world progression-free survival (rwPFS)	It is defined as the time (months) from the start of palbociclib+AI or fulvestrant monotherapy to progressive disease or all-cause mortality. The progressive disease is determined by clinicians based on the results of clinical evaluation, laboratory tests, imaging or pathological examinations. Patients who have not died or have not experienced progressive disease will be censored at the beginning of next-line treatment or at the last visit during the study period.	From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Secondary	Overall survival	It is defined as the time (months) from the start of palbociclib+AI or fulvestrant monotherapy to all-cause mortality. Patients who have not died are censored on the study deadline.	From date of index treatment until date of death from any acuse or date of end of study, whichever came first, assessed up to 36 months.
Secondary	Real-world tumor response (rwTR)	Real world ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) reported by doctors among all patients with response data available.Real world CBR is defined as the proportion of patients who have reached CR, PR, or stable disease (SD) for at least 24 weeks reported by the doctors among all patients with response data available.	From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.