Status:
COMPLETED
Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Collaborating Sponsors:
Cephalon
Sanofi
Conditions:
Breast Cancer
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pati...
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 chemot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00377559
Start Date
May 1 2006
End Date
July 1 2011
Last Update
October 6 2015
Active Locations (10)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5211 NL
2
Wilhelmina Ziekenhuis
Assen, Netherlands, 9400 RA
3
Catharina-Ziekenhuis
Eindhoven, Netherlands, 5602 ZA
4
Ziekenhuis Walcheren
Flushing, Netherlands, 4380 DD