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

NCT05000736 | Unknown

• 1 other identifier: CH-BC-086
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hormone Receptor Positive Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival

  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)

  From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.

Study Arms (2)

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

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

Interventions

palbociclib + aromatase inhibitor DRUG

palbociclib + aromatase inhibitor therapy

palbociclib + aromatase inhibitor

fulvestrant DRUG

fulvestrant monotherapy

fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Chinese women ≥18 years old;
• Diagnosed with locally advanced (stage IIIb/IIIc) or metastatic (stage IV) breast cancer;
• The molecular classification is pathologically confirmed as HR+/HER2-;
• Palbociclib plus AI or fulvestrant monotherapy as initial endocrine therapy for advanced breast cancer for at least 1 cycle;
• The follow-up time should be not less than 3 months after the start of palbociclib plus AI therapy or fulvestrant monotherapy.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

palbociclib; Aromatase Inhibitors; Fulvestrant

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones

Study Officials

• Peng Yuan, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, M.D.

CONTACT

+8613501270834; yuanpeng01@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 11, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)