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Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT03969121•Kyoto Breast Cancer Research Network

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Pre/peri- or post-menopausal women 18 years and older (or local legal age, whichever is higher)
•2. Primary tumor greater than 15 mm in diameter
•3. Histologically proven invasive breast cancer
•4. Positive hormone receptor (ER and/or PgR ≥1% in proportion of positive staining score)
•5. Negative HER-2 receptor (based on 2018 ASCO/CAP Guideline)
•6. Ki67 index equal to or greater than 14% (Ki67 ≥ 14%) by central assessment using actual or virtual slides
•7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
•8. No previous history of radiotherapy or systemic therapy including chemotherapy and hormone therapy for breast cancer
•9. Laboratory values must be as follows:
•Absolute neutrophil count: ≥ 1,500/mm3
+9 more criteria

Exclusion Criteria

•1. Male
•2. Locally advanced breast cancer ( Any T4 or Any N2, N3), or distant metastasis
•3. Multicentric breast cancer (Note: Multifocal breast cancer,located in one quadrant/are is eligible)
•4. Prior treatment with chemotherapy, radiotherapy and/or endocrine therapy
•5. Previous use of SERMs such as raloxifene.
•6. Prior therapy with any CDK4/6 inhibitor or with everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway.
•7. 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
•8. Major surgery within 3 weeks of first study treatment
•9. Patients treated within the last 7 days prior to randomization with:
•* Food or drugs that are known strong and moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, atazanavir, boceprevir, casopitant, cimetidine, ciprof-loxacin, clarithromycin, conivaptan, cobicistat, crizotinib, cyclosporine, da-runavir, diltiazem, dronedarone, elvitegravir, erythromycin, fluconazole, fosamprenavir, imatinib, indinavir, isavuconazole, istradefylline, itraconazole,ketoconazole, letermovir, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, nilotinib, posaconazole, ritonavir, saquinavir, schisandra sphenan-thera extract, telaprevir, telithromycin, tofisopam, verapamil, voriconazole, and grapefruit, grapefruit juice or any product containing grapefruit);
+14 more criteria

Locations (25)

Monash Health

Clayton, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

UNIMED Medical Institute

Hong Kong, Hong Kong

Amagasaki General Medical Center

Amagasaki, Hyōgo, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Kyushu Cancer Center

Fukuoka, Japan

Sagara Hospital

Kagoshima, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

Kyoto University Hospital

Kyoto, Japan

Aichi Cancer Center

Nagoya, Japan

Key Dates

Start Date

July 16, 2019

Primary Completion Date

December 23, 2021

Completion Date

December 23, 2021

Last Updated

March 10, 2023

Enrollment

141

ACTUAL participants

Conditions

Breast Cancer FemaleHormone Receptor Positive Malignant Neoplasm of Breast

Interventions

Palbociclib

DRUG

Endocrine therapy

DRUG

Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)

NCT06322888

Breast CancerBreast Cancer Female

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RECRUITINGNA

Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

NCT06454864

Metabolic DisturbanceSedentary Behavior+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)

Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care (IDSein)

Biennial CEM in Women With a Personal History of Breast Cancer

A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer

The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project