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


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

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:

Interventional

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:

No

Principal Investigator

Jungsil Ro, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

NCCCTS-05-150

NCT ID:

NCT00532285

Start Date:

September 2005

Completion Date:

August 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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