Capecitabine (NX) Versus Docetaxel Plus Capecitabine (TX) as 1-line Chemotherapy on Metastatic Breast Cancer (MBC)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Phase 3

Conditions

Carcinoma, Invasive Ductal, Breast

Treatments

Drug: Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine

Drug: Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01126138

ML25241

Details and patient eligibility

About

It is a phase III trial to explore the efficacy and safety of vinorelbine plus capecitabine (NX) and docetaxel plus capecitabine (TX) as first line treatment followed by capecitabine alone till Progressive Disease(PD). We plan to enroll 200 pts for limited budget and the non-inferior trend of the two curves is anticipated.

Full description

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

Enrollment

200 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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