Chemotherapy for Elderly Patients Diagnosed With Localized HER2 Positive Breast Cancer

August 30, 2016 updated by: Instituto do Cancer do Estado de São Paulo

Neoadjuvant or Adjuvant Chemotherapy Without Anthracyclines for Elderly Patients Diagnosed With HER2 Positive Breast Cancer

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the most common female cancer and the second most common cause of cancer death in women. BC incidence is markedly increased with aging.

Amplification or overexpression of HER2 oncogene is present in approximately 18 to 20% of primary invasive BC. In the absence of HER2 target therapy combined with adjuvant or neoadjuvant chemotherapy, HER2 overexpression or amplification is associated with high rates of disease recurrence and death.

There is major concern regarding chemotherapy related toxicity in the group of women older than 65 years old diagnosed with HER2 positive breast cancer. 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01246-000
        • ICESP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical or Pathological Stage I- IIIA breast adenocarcinoma.
  • HER2 overexpression or amplification defined by immunohistochemistry staining of +3 or positive fluorescence in situ hybridization (FISH) test.
  • Age ≥ 65 years old.
  • WHO performance status less than 2; adequate hematologic (granulocyte count ≥ 2 X 109/L, platelet count ≥100 X109/L) and hepatic (transaminases ≤ 1.5 X the upper limit of normal (ULN), alkaline phosphatases ≤ 2.5 times ULN, and bilirubin ≤ ULN) tests; and normal cardiac function (baseline left ventricular ejection fraction at least ≥ 55%)

Exclusion Criteria:

  • Radiologic imaging of metastatic disease.
  • History of cardiac disease contraindicating anthracyclines, uncontrolled essential hypertension or diabetes, stroke or any other comorbidity that could potentially compromise chemotherapy treatment, such as chronic obstructive pulmonary disease.
  • Any previous treatment with anti HER2 therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Trastuzumab and weekly chemotherapy

Treatment schedule Weekly paclitaxel and Carboplatin at 80mg/m2 and Area under the curve (AUC) of 2, respectively. Weekly trastuzumab will be combined with chemotherapy (at a loading dose of 4mg/kg and a maintenance dose of 2mg/kg). Chemotherapy will be given at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles.

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: 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.

Other Names:
  • Herceptin
  • Other names
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.
Other Names:
  • Taxol
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.
Other Names:
  • Paraplatin
  • Other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS)
Time Frame: 3 years
Disease Free Survival was defined as the time from randomization until first relapse (local, regional, or distant), contralateral breast cancer, or death from any cause.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival (OS)
Time Frame: 2 years
Secondary end points are overall survival (OS), defined from the time from randomization until death from any cause, and safety.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Debora de Gagliato, MD, Instituto do Cancer do Estado de Sao Paulo
  • Study Chair: Max Se Mano, MD phD, Instituto do Cancer do Estado de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2016

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (ESTIMATE)

April 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP 477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no data avalilable

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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