Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer

NCT00532285 | Terminated Phase 2

• 1 other identifier: NCCCTS-05-150
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open labeled phase II single arm trial. The patients with clinical stage II and III will undergo core-needle biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor (ER), progesterone receptor(PR), HER-2/neu and others. PET or ultrasound results will determine the positivity of lymph node metastasis.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)

  two years

Secondary Outcomes (1)

• To assess breast conserving rate To evaluate the disease free survival (DFS) and overall survival (OS) of patients who received preoperatively PG To investigate the toxicity profiles of PG

  two years

Study Arms (1)

Paclitaxel/Gemcitabine

EXPERIMENTAL

paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) every 3 weeks, 4 cycles

Drug: Paclitaxel/Gemcitabine

Interventions

Paclitaxel/Gemcitabine DRUG

Treatment will be delivered in the outpatient setting. Each three-week cycle consists of paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8).Patients will receive four cycles of therapy unless there is any evidence of no response (SD or PD) or unacceptable toxicity defined as unpredictable, irreversible, or Grade 4, or noncompliance by patient with protocol requirements.

Also known as: Paclitaxel, Gemzar

Paclitaxel/Gemcitabine

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage IIA and any stage IIB, III. PET results will determine node positivity. If PET was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration.
• No prior hormonal, chemotherapy or radiotherapy is allowed.
• No breast operation other than biopsy to make diagnosis is allowed.
• Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
• Adequate hematopoietic function: Absolute granulocyte count ³1500/mm3, platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3
• Adequate renal function: Serum creatinine £ 1.5 mg/dl
• Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ two times normal, Alkaline phosphatase: £ two times normal
• Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment
• Adequate mental function to understand and sign the consent

You may not qualify if:

• Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
• Patients who underwent surgery for breast cancer
• Patients with node-negative stage IIA breast cancer
• Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer

Sponsors & Collaborators

• National Cancer Center, Korea: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Gemcitabine

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; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jungsil Ro, MD, PhD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 20, 2007
• Study Start: September 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: August 1, 2009
• Last Updated: June 23, 2011

Record last verified: 2007-09