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

NCT01848197 | Unknown

• 1 other identifier: ZJTC0001
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Paclitaxel; Epirubicin; Cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• disease-free survival

  5 years

• overall survival

  5 years

Other Outcomes (2)

• 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

Study Arms (2)

EC-P2

EXPERIMENTAL

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

EC-P1

ACTIVE COMPARATOR

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

Interventions

paclitaxel DRUG

EC-P1; EC-P2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Taizhou Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Feilin Cao, MD

  Zhejiang Taizhou hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 7, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: May 7, 2013

Record last verified: 2013-05