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PAM50 HER2-enriched Phenotype as a Predictor of Response to Dual HER2 Blockade in HER2-positive Early Breast Cancer

NCT01973660 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2018-09-19

No results posted yet for this study

Summary

Non-randomized, open label, multicentric translational research study in women with untreated invasive breast carcinoma eligible for primary surgery (Stage I-IIIA).

The aim of PAMELA is to test the hypothesis that PAM50 HER2-enriched (HER2-E) subtype better predicts response to neoadjuvant dual anti-HER2 blockade, with or without endocrine therapy, compared to traditional clinical HER2 classification. Furthermore, we posit that characterization of gene expression patterns may identify profiles of those who may be safely spared chemotherapy.

Conditions

Interventions

DRUG

Lapatinib

DRUG

Trastuzumab

DRUG

Endocrine Therapy

Letrozole or tamoxifen will be prescribed according to patient's menopausal status

DRUG

Paclitaxel

Only administrated if tumor progression is observed by US on week 6

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • SOLTI Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Antonio Llombart, MD, PhD · Hospital Arnau de Vilanova de Valencia

  • Aleix Prat, MD, PhD · Vall d'Hebron Institute of Oncology (VHIO)

  • Javier Cortés, MD, PhD · Vall d'Hebron University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-06-30
Completion
2017-12-31

Countries

  • Spain

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 NCT01973660 on ClinicalTrials.gov