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

Sponsor

Taizhou Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01848197

Collaborator

(none)

1,000

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

disease-free survival [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

disease-free survival [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.
overall survival [5 years]
time from randomization to disease death with/without recurrence breast cancer.

Other Outcome Measures

Explore the relationship between neuropathy and DFS and the related predictive biomarkers (RWDD3 and TECTA gene SNP etc) [3 years]
Explore predictive biomarker of neutropenia; [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18-70 years female operable breast cancer patients
Patients were required to register within 60 days from the final surgical procedure required to adequately treat the invasive primary tumor.
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.
Karnofsky points greater than or equal to 70.
Postmenopausal women or HCG test results were negative, Women of child-bearing potential willing to use effective contraception during the study.
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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taizhou Hospital

Investigators

Principal Investigator: Feilin Cao, MD, Zhejiang Taizhou hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Feilin Cao, MD, Taizhou Hospital

ClinicalTrials.gov Identifier:

NCT01848197

Other Study ID Numbers:

ZJTC0001

First Posted:

May 7, 2013

Last Update Posted:

May 7, 2013

Last Verified:

May 1, 2013

Additional relevant MeSH terms:

Breast Neoplasms

Paclitaxel

Study Results

No Results Posted as of May 7, 2013