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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hormone Receptor Positive Advanced Breast Cancer
• Intervention / Treatment: Drug: palbociclib + aromatase inhibitor; Drug: fulvestrant

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus AI or fulvestrant monotherapy at the Cancer Hospital Chinese Academy of Medical Sciences from August 1, 2018 to December 31, 2020.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
palbociclib + aromatase inhibitor; Adult patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus aromatase inhibitor at the Cancer Hospital Chinese Academy of Medical Sciences from August 1, 2018 to December 31, 2020.	Drug: palbociclib + aromatase inhibitor; palbociclib + aromatase inhibitor therapy
fulvestrant; Adult patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of fulvestrant monotherapy at the Cancer Hospital Chinese Academy of Medical Sciences from August 1, 2018 to December 31, 2020.	Drug: fulvestrant; fulvestrant monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (ACTUAL): August 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protein Kinase Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant; Palbociclib; Aromatase Inhibitors
• Other Study ID Numbers: CH-BC-086

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No