Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Pr… (NCT03969121) | Clinical Trial Compass
CompletedPhase 3
Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer
Australia, Hong Kong, Japan141 participantsStarted 2019-07-16
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Pre/peri- or post-menopausal women 18 years and older (or local legal age, whichever is higher)
✓. Primary tumor greater than 15 mm in diameter
✓. Histologically proven invasive breast cancer
✓. Positive hormone receptor (ER and/or PgR ≥1% in proportion of positive staining score)
✓. Negative HER-2 receptor (based on 2018 ASCO/CAP Guideline)
✓. Ki67 index equal to or greater than 14% (Ki67 ≥ 14%) by central assessment using actual or virtual slides
✓. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
✓. No previous history of radiotherapy or systemic therapy including chemotherapy and hormone therapy for breast cancer
Exclusion criteria
✕. Male
✕. Locally advanced breast cancer ( Any T4 or Any N2, N3), or distant metastasis
✕. Multicentric breast cancer (Note: Multifocal breast cancer,located in one quadrant/are is eligible)
✕. Prior treatment with chemotherapy, radiotherapy and/or endocrine therapy
✕. Previous use of SERMs such as raloxifene.
What they're measuring
1
Pre-operative Endocrine Prognostic Index (PEPI Score)
. Prior therapy with any CDK4/6 inhibitor or with everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway.
✕. Prior history of other malignancy within 5 years of study entry, aside from basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix
✕. Major surgery within 3 weeks of first study treatment