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An Open, Randomized, Parallel-group, Multicenter Clinical Study to Evaluate Efficacy and Safety of Paclitaxel Every 2 Weeks Compared Weekly in Adjuvant Treatment of Breast Cancer


N/A
18 Years
70 Years
Not Enrolling
Female
Breast Cancer, Paclitaxel, Epirubicin, Cyclophosphamide

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Trial Information

An Open, Randomized, Parallel-group, Multicenter Clinical Study to Evaluate Efficacy and Safety of Paclitaxel Every 2 Weeks Compared Weekly in Adjuvant Treatment of Breast Cancer


Inclusion Criteria:



1. Age between 18-70 years female operable breast cancer patients

2. Patients were required to register within 60 days from the final surgical procedure
required to adequately treat the invasive primary tumor.

3. women who had operable,histologically confirmed adenocarcinoma of the breast with a.
histologically involved positive lymph nodes b. or histologic diagnosis for three
negative patients; c. or lymph node negative, HER2 positive(if HER2 + +, FISH
(fluorescence in situ hybridization method)/CISH tests confirmed HER2 amplification
is positive),but unable or intolerant to herceptin combined chemotherapy.

4. Karnofsky points greater than or equal to 70.

5. Postmenopausal women or HCG test results were negative, Women of child-bearing
potential willing to use effective contraception during the study.

6. PATIENT CHARACTERISTICS:

Hematopoietic:

- Neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal

- TBIL no greater than 1.5 times upper limit of normal

- AKP no greater than 2.5 times upper limit of normal

- AST no greater than 2.5 times upper limit of normal

- ALT no greater than 2.5 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 times upper limit of normal

Cardiovascular:

- No history of myocardial infarction

- No congestive heart failure

- No significant ischemic or valvular heart disease

Other:

- No other prior invasive malignancies within the past 5 years except curatively
treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

- No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs
(with Cremophor or polysorbate)

Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

-

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:

disease-free survival

Outcome Description:

time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Feilin Cao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Taizhou Hospital

Authority:

China: Food and Drug Administration

Study ID:

ZJTC0001

NCT ID:

NCT01848197

Start Date:

May 2013

Completion Date:

December 2020

Related Keywords:

  • Breast Cancer
  • Paclitaxel
  • Epirubicin
  • Cyclophosphamide
  • Breast Neoplasms

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