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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00532285
• Other study ID #: NCCCTS-05-150
• Status: Terminated
• Phase: Phase 2
• First received: September 19, 2007
• Last updated: June 22, 2011
• Start date: September 2005
• Est. completion date: August 2009

Study information

• Verified date: September 2007
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be treated as follows:

PG x 4®operation®AC x 4®radiation ± tamoxifen/AI(postmenopausal)

Intravenous infusion of Paclitaxel 80 mg/m2, over 60 min, on D1 and D8 Followed by intravenous infusion of Gemcitabine 1200 mg/m2, over 30 min, on D1 and D8

The cycle repeats every 3 weeks for 4 times. Premedication includes antiemetics, dexamethasone, famotidine, pheniramine as routinely given.

After the operation, standard adjuvant chemotherapy (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2, every 3 weeks x 4 cycles) will be given.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: August 2009
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Paclitaxel/Gemcitabine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)		two years	No
Secondary	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	No