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Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer (PATEN)

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ClinicalTrials.gov Identifier: NCT01848197
Recruitment Status : Not yet recruiting
First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
Feilin Cao, Taizhou Hospital

Brief Summary:
RATIONALE: Adjuvant chemotherapy has been proven to reduce significantly the risk for relapse and death in women with operable breast cancer.In the North American Inter-Group factorial trial design (CALGB 9741) the concept of dosedense adjuvant chemotherapy was further tested in patients with node-positive breast cancer.Weekly paclitaxel after standard adjuvant chemotherapy with epirubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer.Investigators asked if dose-dense 2-week intertreatment intervals (supported by the use of granulocyte-colony stimulating factor) were better than the conventional inconvenient weekly intervals.

Condition or disease Intervention/treatment Phase
Breast Cancer Paclitaxel Epirubicin Cyclophosphamide Drug: paclitaxel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: EC-P2
all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 2-week intervals for 4 cycles.
Drug: paclitaxel
Active Comparator: EC-P1
all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 1-week intervals for 12 cycles.
Drug: paclitaxel



Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years ]
    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.

  2. overall survival [ Time Frame: 5 years ]
    time from randomization to disease death with/without recurrence breast cancer.


Other Outcome Measures:
  1. Explore the relationship between neuropathy and DFS and the related predictive biomarkers (RWDD3 and TECTA gene SNP etc) [ Time Frame: 3 years ]
  2. Explore predictive biomarker of neutropenia; [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848197


Sponsors and Collaborators
Taizhou Hospital
Investigators
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Principal Investigator: Feilin Cao, MD Zhejiang Taizhou Hospital

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Responsible Party: Feilin Cao, MD, Taizhou Hospital
ClinicalTrials.gov Identifier: NCT01848197     History of Changes
Other Study ID Numbers: ZJTC0001
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action