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Chemotherapy for Elderly Patients Diagnosed With Localized HER2 Positive Breast Cancer

NCT02102438 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-08-31

No results posted yet for this study

Summary

There is major concern regarding chemotherapy related toxicity in the group of women older than 65 years old diagnosed with human epidermal growth factor receptor 2 (HER2) positive breast cancer (BC). Nevertheless, these patients are at a particularly high risk of breast cancer recurrence and death. Of note, older patients may experience higher risk for Trastuzumabe related cardiotoxicity, especially when this agent is combined with an anthracycline.

Recent studies have shown extremely favourable outcomes in early HER2+ BC patients treated with a combination of paclitaxel and trastuzumab, omitting anthracyclines from treatment.

Investigators sought to investigate safety and outcome data on a cohort of elderly patients treated with weekly paclitaxel combined with carboplatin and trastuzumab.

Conditions

Interventions

DRUG

Trastuzumab

Trastuzumab (at a loading dose of 4mg/kg and a maintenance dose of 2mg/kg) will be given concomitantly with chemotherapy. After completion of four chemotherapy cycles, Trastuzumab will be given at a dose of 6mg/kg every 21 days, for a total 14 cycles.

DRUG

Weekly Paclitaxel

Weekly paclitaxel at 80mg/m2 at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles.

DRUG

Carboplatin

Carboplatin at an Area Under the Curve (AUC) of 2 at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles.

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Debora de Gagliato, MD · Instituto do Cancer do Estado de São Paulo

  • Max Se Mano, MD phD · Instituto do Cancer do Estado de São Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2018-04-30

Countries

  • Brazil

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 NCT02102438 on ClinicalTrials.gov