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Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer (MYOTAX)

Primary Purpose

Breast Cancer, Neoplasm Metastasis

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Non pegylated liposomal doxorubicin and docetaxel
Sponsored by
Catharina Ziekenhuis Eindhoven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, metastatic, cardiotoxicity, liposomal, doxorubicin, docetaxel, HER2/neu negative metastatic breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with histologically documented metastatic or locally advanced metastatic HER2/neu negative breast cancer.
  • In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or taxanes, this must have been completed more than 12 months before inclusion.
  • In the case of previous adjuvant or neoadjuvant chemotherapy, cumulative anthracycline dose ≤ 360 mg/m2 of doxorubicin or 600 mg/m2 of epirubicin or 75 mg/m2 of mitoxantrone on inclusion.
  • Previous endocrine therapy is authorized (endocrine therapy other than goserelin must be stopped before starting treatment).
  • Previous radiotherapy is authorized, if discontinued ≥ 4 weeks prior to inclusion in the study and if < 10% of the bone marrow was within the irradiated area.
  • Age ≥ 18 years.
  • Performance status 0,1, or 2.
  • Life expectancy ≥ 3 months.
  • Evaluable disease.
  • Normal LVEF (multigated acquisition [MUGA] scan or echocardiography).
  • Normal haematological, hepatic and renal parameters: neutrophils ≥ 1.5 x 10^9/l; platelets ≥ 100 x 10^9/l; hemoglobin (Hb) ≥ 6 mmol/L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); transaminases ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN; creatinine ≤ 1.5 x ULN.
  • Dated and signed written informed consent.

Exclusion Criteria:

  • Previous chemotherapy for metastatic disease.
  • History of other cancer, except for cervical carcinoma in situ treated by cone resection or basal cell or squamous cell skin cancer.
  • History of congestive heart failure or myocardial infarction ≤ 1 year; cardiac function: NYHA ≥ 2 or LVEF < 50%. Uncontrolled significant heart disease, such as unstable angina.
  • Poorly controlled hypertension.
  • Performance status 3, 4.
  • Symptomatic or progressive brain metastases.
  • Active infection or other serious underlying disease.
  • Concomitant participation in other clinical trials.
  • Pregnant women or nursing mothers; patients of childbearing potential without effective contraception.
  • Absolute medical contraindication to the use of corticosteroid premedication.
  • Allergy to polysorbate 80, doxorubicin, or egg lecithin.
  • NCI-CTC grade > 1 peripheral neuropathy.
  • Patients not able to comply with regular medical follow-up

Sites / Locations

  • Jeroen Bosch Ziekenhuis
  • Wilhelmina Ziekenhuis
  • Catharina-Ziekenhuis
  • Ikazia Ziekenhuis
  • Sint Elisabeth Ziekenhuis
  • Mesos Medisch Centrum
  • Maxima Medisch Centrum
  • VieCuri MC
  • Ziekenhuis Walcheren
  • Streekziekenhuis Koningin Beatrix

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1.

Arm Description

Myocet+docetaxel

Outcomes

Primary Outcome Measures

Cardiotoxicity (definite or probable cardiac death)
Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV
Decline in left ventricular ejection fraction (LVEF) of ≥ 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III)
Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF

Secondary Outcome Measures

Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification
Response rate
Median time to progression
Progression free survival

Full Information

First Posted
September 15, 2006
Last Updated
October 5, 2015
Sponsor
Catharina Ziekenhuis Eindhoven
Collaborators
Cephalon, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00377559
Brief Title
Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer
Acronym
MYOTAX
Official Title
Phase II Multicentre Open Label Trial Evaluating the Efficacy and Safety of the Liposomal Doxorubicin (Myocet®) and Docetaxel (Taxotere®) Combination as First-line Treatment of Patients With Metastatic HER2/Neu Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catharina Ziekenhuis Eindhoven
Collaborators
Cephalon, Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open phase II multicentre study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu negative breast cancer.
Detailed Description
Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu negative breast cancer not yet treated with chemotherapy for metastatic disease. Myocet and Taxotere will be given for a maximum of 6 cycles. Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neoplasm Metastasis
Keywords
Breast cancer, metastatic, cardiotoxicity, liposomal, doxorubicin, docetaxel, HER2/neu negative metastatic breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.
Arm Type
Experimental
Arm Description
Myocet+docetaxel
Intervention Type
Drug
Intervention Name(s)
Non pegylated liposomal doxorubicin and docetaxel
Other Intervention Name(s)
Myocet, Taxotere
Intervention Description
max. 6 courses
Primary Outcome Measure Information:
Title
Cardiotoxicity (definite or probable cardiac death)
Time Frame
treatment period
Title
Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV
Time Frame
treatment period
Title
Decline in left ventricular ejection fraction (LVEF) of ≥ 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III)
Time Frame
treatment period
Title
Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF
Time Frame
treatment period
Secondary Outcome Measure Information:
Title
Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification
Time Frame
treatment period
Title
Response rate
Time Frame
treatment period
Title
Median time to progression
Time Frame
treatment period
Title
Progression free survival
Time Frame
treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with histologically documented metastatic or locally advanced metastatic HER2/neu negative breast cancer. In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or taxanes, this must have been completed more than 12 months before inclusion. In the case of previous adjuvant or neoadjuvant chemotherapy, cumulative anthracycline dose ≤ 360 mg/m2 of doxorubicin or 600 mg/m2 of epirubicin or 75 mg/m2 of mitoxantrone on inclusion. Previous endocrine therapy is authorized (endocrine therapy other than goserelin must be stopped before starting treatment). Previous radiotherapy is authorized, if discontinued ≥ 4 weeks prior to inclusion in the study and if < 10% of the bone marrow was within the irradiated area. Age ≥ 18 years. Performance status 0,1, or 2. Life expectancy ≥ 3 months. Evaluable disease. Normal LVEF (multigated acquisition [MUGA] scan or echocardiography). Normal haematological, hepatic and renal parameters: neutrophils ≥ 1.5 x 10^9/l; platelets ≥ 100 x 10^9/l; hemoglobin (Hb) ≥ 6 mmol/L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); transaminases ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN; creatinine ≤ 1.5 x ULN. Dated and signed written informed consent. Exclusion Criteria: Previous chemotherapy for metastatic disease. History of other cancer, except for cervical carcinoma in situ treated by cone resection or basal cell or squamous cell skin cancer. History of congestive heart failure or myocardial infarction ≤ 1 year; cardiac function: NYHA ≥ 2 or LVEF < 50%. Uncontrolled significant heart disease, such as unstable angina. Poorly controlled hypertension. Performance status 3, 4. Symptomatic or progressive brain metastases. Active infection or other serious underlying disease. Concomitant participation in other clinical trials. Pregnant women or nursing mothers; patients of childbearing potential without effective contraception. Absolute medical contraindication to the use of corticosteroid premedication. Allergy to polysorbate 80, doxorubicin, or egg lecithin. NCI-CTC grade > 1 peripheral neuropathy. Patients not able to comply with regular medical follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence J. van Warmerdam, MD, PhD
Organizational Affiliation
Catharina Ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeroen Bosch Ziekenhuis
City
's-Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
Wilhelmina Ziekenhuis
City
Assen
ZIP/Postal Code
9400 RA
Country
Netherlands
Facility Name
Catharina-Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5602 ZA
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Sint Elisabeth Ziekenhuis
City
Tilburg
ZIP/Postal Code
5000 LC
Country
Netherlands
Facility Name
Mesos Medisch Centrum
City
Utrecht
ZIP/Postal Code
3527 CE
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
ZIP/Postal Code
5500 MB
Country
Netherlands
Facility Name
VieCuri MC
City
Venlo
ZIP/Postal Code
5900 BX
Country
Netherlands
Facility Name
Ziekenhuis Walcheren
City
Vlissingen
ZIP/Postal Code
4380 DD
Country
Netherlands
Facility Name
Streekziekenhuis Koningin Beatrix
City
Winterswijk
ZIP/Postal Code
7100 GG
Country
Netherlands

12. IPD Sharing Statement

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Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer

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