CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 147 enrolled
Drug / intervention
Paclitaxel +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03644186
NCT03644186Phase 2Completed
CompareCT.gov

Phase II Open-label, Multicentre, Randomized Trial of Neoadjuvant Palbociclib in Combination With Hormonal Therapy and HER2 Blockade Versus Paclitaxel in Combination With HER2 Blockade for Postmenopausal Patients With Hormone Receptor Positive/HER2 Positive Early Breast Cancer

ETOP IBCSG Partners Foundation·interventional·Posted Aug 23, 2018·Updated Dec 13, 2024

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Trastuzumab, and 3 other interventions for Breast Cancer and 2 related conditions. Completed, enrolled 147 participants across 54 sites in 4 countries.

Detailed Summary

This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
CountriesBelgium, France, Italy, Switzerland
CollaboratorsPfizer, Hoffmann-La Roche

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 23, 2018
Enrollment StartApr 16, 2019
Primary CompletionJan 3, 2023
Study CompletionApr 14, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.9 years ago

Interventions

Paclitaxeldrug

Chemotherapy plus HER2 Blockade

Trastuzumabdrug

Chemotherapy plus HER2 Blockade

Pertuzumabdrug

Chemotherapy plus HER2 Blockade

Palbociclibdrug

CDK Inhibition plus Hormonal Therapy plus HER2 Blockade

Letrozoledrug

CDK Inhibition plus Hormonal Therapy plus HER2 Blockade

Trastuzumabdrug

CDK Inhibition plus Hormonal Therapy plus HER2 Blockade

Pertuzumabdrug

CDK Inhibition plus Hormonal Therapy plus HER2 Blockade