Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer

Breast Cancer Clinical Trial

— MYOHERTAX  

Official title:

Phase II Multicentre Open Label Study Evaluating the Efficacy and Safety of Liposomal Doxorubicin, Trastuzumab, Docetaxel as First-line Treatment of Patients With HER2 Positive Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00377780
• Other study ID #: MYOHERTAX
• Status: Terminated
• Phase: Phase 2
• First received: September 14, 2006
• Last updated: September 22, 2015
• Start date: August 2006
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

This is an open phase II study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®), trastuzumab (Herceptin®), and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu positive breast cancer.

Description:

Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu positive breast cancer not yet treated with chemotherapy for metastatic disease.

Myocet and Taxotere will be given for a maximum of 6 cycles, Herceptin treatment for 1 year is recommended.

Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with histologically documented metastatic or locally advanced metastatic HER2/neu positive breast cancer at 1st line of palliative chemotherapy.

• 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 = 240 mg/m2 of doxorubicin or 450 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Non pegylated liposomal doxorubicin, trastuzumab, docetaxel
max. 6 courses

Locations

Country	Name	City	State
Netherlands	Ziekenhuis Rijnstate	Arnhem
Netherlands	Wilhelmina Ziekenhuis	Assen
Netherlands	Catharina-Ziekenhuis	Eindhoven
Netherlands	Ikazia Ziekenhuis	Rotterdam
Netherlands	Maxima Medisch Centrum	Veldhoven
Netherlands	VieCuri MC	Venlo
Netherlands	Streekziekenhuis Koningin Beatrix	Winterswijk

Sponsors (3)

Lead Sponsor	Collaborator
Laurence J.C. van Warmerdam	Cephalon, Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiotoxicity (definite or probable cardiac death)		treatment period	Yes
Primary	Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV		treatment period	Yes
Primary	Decline in left ventricular ejection fraction (LVEF) of = 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III)		treatment period	Yes
Primary	Decline in LVEF of = 10% to < 50% without signs or symptoms of CHF		treatment period	Yes
Secondary	Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification		treatment period	Yes
Secondary	Response rate		treatment period	No
Secondary	Median time to progression		treatment period	No
Secondary	Progression free survival		treatment period	No