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Overcoming Endocrine Resistance in Metastatic Breast Cancer

NCT02394496 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2016-06-15

No results posted yet for this study

Summary

Based on these results it can be envisioned that the majority of endocrine-responsive post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy (front-line, switching or extending) and/or as first-line management of metastatic breast cancer.

Conditions

Interventions

DRUG

Fulvestrant

Fulvestrant 500mg (2 x 5ml) im injections as a loading dose on Day 0, followed by 500mg (2x5ml) on Day 14 (+/- 3 days) , Day 28 (+/- 3 days) and every 28 Days (+/- 3 days) thereafter.

DRUG

Lapatinib

1500mg (TBD) O.S. qd

DRUG

Aromatase Inhibitors

as indicated in the Summary Product Characteristic

DRUG

Placebo Lapatinib

1500mg (TBD) O.S. qd

Sponsors & Collaborators

  • Consorzio Oncotech

    lead OTHER

Principal Investigators

  • Sabino De Placido, MD · Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"

  • Michelino De Laurentiis, MD · Istituto Nazionale dei Tumori - Fondazione G. Pascale

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • Italy

Study Locations

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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 NCT02394496 on ClinicalTrials.gov