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

Primary Purpose

Breast Cancer, Paclitaxel, Epirubicin

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

paclitaxel

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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:

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EC-P2

EC-P1

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

disease-free survival

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

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

time from randomization to disease death with/without recurrence breast cancer.

Full Information

NCT ID

NCT01848197

First Posted

May 2, 2013

Last Updated

May 6, 2013

Sponsor

Taizhou Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01848197

Brief Title

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

Acronym

PATEN

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 Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taizhou Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Paclitaxel, Epirubicin, Cyclophosphamide

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EC-P2

Arm Type

Experimental

Arm Description

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.

Arm Title

EC-P1

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Primary Outcome Measure Information:

Title

disease-free survival

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.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

disease-free survival

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.

Time Frame

5 years

Title

overall survival

Description

time from randomization to disease death with/without recurrence breast cancer.

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Explore the relationship between neuropathy and DFS and the related predictive biomarkers (RWDD3 and TECTA gene SNP etc)

Time Frame

3 years

Title

Explore predictive biomarker of neutropenia;

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Feilin Cao, MD

Organizational Affiliation

Zhejiang Taizhou hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

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

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