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Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer

NCT02448420 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-04-18

No results posted yet for this study

Summary

PATRICIA is a phase II, open-label, multicentre, Simon's two-stage-design study of the combination of palbociclib plus trastuzumab, with or without letrozole, in post-menopausal patients with HER2-positive locally advanced or metastatic breast cancer (MBC) who have received chemotherapy and treatment with trastuzumab for their metastatic disease. Cohorts A, B1, and B2 based on their HR status and treatment allocation were planned.

Cohort A included patients with hormone receptor-negative, HER2 positive breast cancer, who received trastuzumab + palbociclib.

Cohort B1 included patients with hormone receptor-positive, HER2 positive breast cancer, who received trastuzumab + palbociclib.

Cohort B2 included patients with hormone receptor-positive, HER2 positive breast cancer, who received trastuzumab + palbociclib + letrozole.

The aim of the PATRICIA study is to test the hypothesis that the addition of Palbociclib to standard therapy is well tolerated and can provide a benefit in progression-free survival.

Based on interim results from this trial that support the benefit of CDK4 / 6 inhibition in luminal disease, two additional cohorts will be included.

Conditions

Interventions

DRUG

Palbociclib

Cohort A, B1 y B2: Palbociclib oral dose of 200 mg/day for 2 weeks, followed by 1 week off. Cohort C1: Palbociclib oral dose 125 mg/d for 3 weeks, followed by one week off, in 4-week cycles.

DRUG

Trastuzumab

Loading dose of 8mg/kg intravenous (iv) followed by 6 mg/kg once every 3 weeks; or subcutaneous trastuzumab 600mg every 3 weeks.

DRUG

Endocrine therapy

Non-steroidal AIs (anastrozole, letrozole); steroidal AI (exemestane); Fulvestrant or Tamoxifen

DRUG

Chemotherapy

Gemcitabine, vinorelbine, capecitabine, eribulin or a taxane

DRUG

Antibody-Drug Conjugates

3.6 mg/kg iv every 3 weeks

Sponsors & Collaborators

  • SOLTI Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Eva Ciruelos, MD · SOLTI Breast Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2023-09-29
Completion
2023-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02448420 on ClinicalTrials.gov