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

Phase 2
Not Enrolling
Breast Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

two years

Safety Issue:


Principal Investigator

Jungsil Ro, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

September 2005

Completion Date:

August 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms