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

• ClinicalTrials.gov Identifier: NCT00377559
• Recruitment Status: Completed
• First Posted: September 18, 2006
• Last Update Posted: October 6, 2015
• Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Cephalon; Sanofi
• Information provided by: Catharina Ziekenhuis Eindhoven

Tracking Information

• First Submitted Date: September 15, 2006
• First Posted Date: September 18, 2006
• Last Update Posted Date: October 6, 2015
• Study Start Date: May 2006
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 28, 2008)

• Cardiotoxicity (definite or probable cardiac death) [ Time Frame: treatment period ]
• Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV [ Time Frame: treatment period ]
• 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 ]
• Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF [ Time Frame: treatment period ]

• Original Primary Outcome Measures (submitted: September 15, 2006): Cardiotoxicity (Definite or probable cardiac death.Signs or symptoms of CHF, NYHA class III-IV. Decline in 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.

Current Secondary Outcome Measures (submitted: July 28, 2008)

• Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification [ Time Frame: treatment period ]
• Response rate [ Time Frame: treatment period ]
• Median time to progression [ Time Frame: treatment period ]
• Progression free survival [ Time Frame: treatment period ]

• Original Secondary Outcome Measures (submitted: September 15, 2006): Frequency and severity of intercurrent events according to the NCI-CTC classification•; Response rate; Median time to progression; Progression free survival
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer
• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Breast Cancer
• Neoplasm Metastasis

Intervention

Drug: Non pegylated liposomal doxorubicin and docetaxel

max. 6 courses

Other Name: Myocet, Taxotere

Study Arms

Experimental: 1.

Myocet+docetaxel

Intervention: Drug: Non pegylated liposomal doxorubicin and docetaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 9, 2009): 70
• Original Enrollment (submitted: September 15, 2006): 60
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00377559
• Other Study ID Numbers: MYOTAX
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Raymond J.P. Schmidt, MD, Stichting (Foundation) BO3
• Study Sponsor: Catharina Ziekenhuis Eindhoven

Collaborators

• Cephalon
• Sanofi

Investigators

• Principal Investigator: Laurence J. van Warmerdam, MD, PhD; Catharina-Ziekenhuis

• PRS Account: Catharina Ziekenhuis Eindhoven
• Verification Date: August 2011