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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Paclitaxel; Cyclophosphamide; Epirubicin
• Intervention / Treatment: Drug: paclitaxel

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years
overall survival	time from randomization to disease death with/without recurrence breast cancer.	5 years

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Taizhou Hospital
• Investigators: Principal Investigator: Feilin Cao, MD, Zhejiang Taizhou Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: May 6, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 6, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: ZJTC0001