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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01848197
• Other study ID #: ZJTC0001
• Status: Not yet recruiting
• Phase: N/A
• First received: May 2, 2013
• Last updated: May 6, 2013
• Start date: May 2013
• Est. completion date: December 2020

Study information

• Verified date: May 2013
• Source: Taizhou Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cyclophosphamide
• Epirubicin
• Paclitaxel

Intervention

Drug:
• paclitaxel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explore the relationship between neuropathy and DFS and the related predictive biomarkers (RWDD3 and TECTA gene SNP etc)		3 years	No
Other	Explore predictive biomarker of neutropenia;		5 years	No
Primary	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	Yes
Secondary	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	Yes
Secondary	overall survival	time from randomization to disease death with/without recurrence breast cancer.	5 years	Yes