A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients.
18 Years
N/A
Female
Carcinoma, Invasive Ductal, Breast
Trial Information
A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients.
We designed the randomized non-inferiority study. Main Inclusion& exclusion Criteria
include: 1) Histologically or cytologically confirmed breast cancer with unresectable
locally advanced and/or metastatic disease; 2) Untreated patients with unresectable locally
advanced and/or metastatic disease; 3) with at least 1 lesion measurable by radiological
method(RECIST criteria); 4) Karnofsky Performance Status(KPS)≥70; 5) normal Adequate
hepatic, renal, and bone marrow function; 6) Life expectancy of at least 12 weeks; 7) No
previous chemotherapy for metastatic breast cancer. Primary endpoint is Progression free
survival(PFS), second endpoint are safety profiles (National Cancer Institute-Common
Toxicity Criteria 3.0, NCI-CTC 3.0), overall survival and response rate. During Primary
study treatment, Arm A: Capecitabine: 1,000 mg/m2 per ora(PO) twice daily (day 1-14),
Vinorelbine 25 mg/m2 intravenous(IV) over 3 hours on day 1 and 8, every 3 weeks, 21 days as
one cycle and 6-8 cycles are required; Arm B: Capecitabine: 1,000 mg/m2 PO twice daily (day
1-14), Docetaxel 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and
6-8 cycles are required. Patients who are responding (complete or partial), or whose disease
is stable followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one
cycle until progression or unacceptable toxicity
Inclusion Criteria:
- Written and signed informed consent prior to beginning specific protocol procedures.
- Pathologically confirmed breast cancer and documented metastatic or locally advanced
disease.
Measurable disease (RECIST criteria) - with at least 1 lesion measurable by radiological
method
- KPS>=70
- Adjuvant and/or Neoadjuvant chemotherapy, including an anthracycline was permitted
- Hormone therapy for early-stage or metastatic breast cancer was permitted if hormonal
receptor positive.
- Treatment with Herceptin for early-stage or metastatic breast cancer is permitted if
HER2 positive
- Patients had to have concluded prior radiation therapy at least 14 days before
enrollment.
- Laboratory requirements:
- Hematology Absolute neutrophil count>=1,500 /μl; Platelets>=100,000 /μl;
Hemoglobin>=10 g/dl
- Liver function Total bilirubin<=2 times ULN ASAT (SGOT) and ALAT (SGPT)<=2.5
times UNL without liver metastasis or <=5.0 times if liver metastasis
Glucose<=200 mg/dL
- Renal function Serum creatinine<=140 mol/l
- Life expectancy of at least 12 weeks
- Patients must be accessible for treatment and follow-up.
- Patients should have recovered from the acute reversible effects of prior treatment.
This generally means at least 3 weeks should have elapsed since prior chemotherapy,
adjuvant or Neoadjuvant treatment. and at least 4 weeks since prior (radical)
radiotherapy or major surgery
Exclusion Criteria:
- Women who are pregnant or breast feeding
- History of brain and/or leptomeningeal metastases
- Previous chemotherapy for metastatic breast cancer
- Past or current history of malignant neoplasm other than breast carcinoma, except for
curatively treated non melanoma skin cancer, in situ carcinoma of the cervix or other
cancer curatively treated and with no evidence of disease for at least 5 years
- Pre-existing neuropathy grade 1 according to the NCIC-CTC 3.0
- Psychiatric disorders or other conditions which would prevent pt. compliance
- Other serious illness or medical condition:
- Congestive heart failure, or unstable angina pectoris, previous history of
myocardial infarction within 6 month prior to study entry, uncontrolled
hypertension as determined by the Investigator or high risk uncontrolled,
arrhythmia.
- History of significant neurological or psychiatric disorders including psychotic
disorders, dementia of seizures that would prohibit the understanding and giving
of informed consent.
- Active uncontrolled infection.
- Unstable peptic ulcer, unstable diabetes mellitus or other contraindication for
the use of Corticosteroids.
- Inability to take and/or absorb oral medicine
- Prior treatment with an docetaxel and/or capecitabine and/or vinorbine
- Concurrent treatment with other experimental drugs, or participation in another
clinical trial with any investigational drug within 30 days prior to study entry
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival(PFS)
Outcome Description:
Progress free survival is defined as the time from first dose of test drug to the first recording of disease progression or the date of death in patients with no evidence of disease progression. In addition to hazard ratios and associated 95% confidence intervals, the results from these analyses will, for each treatment arm, also be summarized by Kaplan-Meier plots, medians and 95% confidence intervals.
Outcome Time Frame:
Up to 2 years until disease progression or death
Safety Issue:
No
Principal Investigator
Binghe Xu, MD, Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Authority:
China: Food and Drug Administration
Study ID:
ML25241
NCT ID:
NCT01126138
Start Date:
July 2010
Completion Date:
August 2015
Related Keywords:
- Carcinoma, Invasive Ductal, Breast
- unresectable
- locally advanced
- metastatic
- breast cancer
- Breast Neoplasms
- Carcinoma
- Carcinoma, Ductal, Breast
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