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

Taizhou Hospital

Status: Unknown

Conditions: Breast Cancer; Paclitaxel; Epirubicin; Cyclophosphamide

Treatments: Drug: paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01848197

ZJTC0001

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

EC-P2

Experimental group

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.

Treatment:

Drug: paclitaxel

EC-P1

Active Comparator group

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.

Treatment:

Drug: paclitaxel