Clinical trial NCT00532285: Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
Official title: Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2007-09-20
Enrollment: 44
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)
timeFrame: two years
Secondary outcomes:
measure: 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
timeFrame: two years
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Center
name: Jungsil Ro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: