NCT03969121

Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

A Phase III Randomized, Double-Blind, Neoadjuvant Study of Hormonal Therapy Plus Palbociclib Versus Hormonal Therapy Plus Placebo in Women With Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Kyoto Breast Cancer Research Network · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the efficacy of palbociclib in combination with Endocrine therapy over Endocrine therapy alone measured by PEPI and EndoPredict™ EPclin Score in women with operable HR+, HER2 negative breast cancer . The Clinical Response Rate, drop in Ki67 index ≤ 2.7% and Breast conserving rate will be compared between two arms.

Conditions

• Breast Cancer Female
• Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib will be administered orally once a day for 21 days every 28-day cycle followed by 7 days off treatment
DRUG	Endocrine therapy	Pre- and peri-menopausal women will be receiving Ovarian Function Suppression (OFS) by either leuprorelin subcutaneous 3.75 mg q28days or goserelin subcutaneous 3.6 mg q28days plus tamoxifen 20 mg QD in 28-day cycles. Post-menopausal women will receive letrozole 2.5 mg QD in 28-day cycles.

Timeline

• Start date: 2019-07-16
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2019-05-31
• Last updated: 2023-03-10

Locations

25 sites across 5 countries: Australia, Hong Kong, Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study