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To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)

NCT03644186 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2024-12-13

Study results available
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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.

Conditions

Interventions

DRUG

Paclitaxel

Chemotherapy plus HER2 Blockade

DRUG

Trastuzumab

Chemotherapy plus HER2 Blockade

DRUG

Pertuzumab

Chemotherapy plus HER2 Blockade

DRUG

Palbociclib

CDK Inhibition plus Hormonal Therapy plus HER2 Blockade

DRUG

Letrozole

CDK Inhibition plus Hormonal Therapy plus HER2 Blockade

DRUG

Trastuzumab

CDK Inhibition plus Hormonal Therapy plus HER2 Blockade

DRUG

Pertuzumab

CDK Inhibition plus Hormonal Therapy plus HER2 Blockade

Sponsors & Collaborators

Principal Investigators

  • Laura Biganzoli, MD · USL4 Hospital of Prato, Italy

  • Etienne Brain, MD · Institut Curie, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2023-01-03
Completion
2023-04-14

Countries

  • Belgium
  • France
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03644186 on ClinicalTrials.gov