Phase1 trial of weekly paclitaxel and gemcitabine in previously anthracycline-treated patients with locally advanced or metastatic breast cancer (SBCCSG-17)

Not Applicable

• Conditions: Breast Cancer

• Registration Number: JPRN-UMIN000004084
• Lead Sponsor: Saitama Breast Cancer Clinical Study Group(SBCCSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patient had received gemcitabine treatment in the past. 2)Patient with inflammatory carcinoma. 3)Patient apparently or possibly has pulmonary fibrosis or pneumonia. 4)Patient is class III or IV of NYHA functional classification or patient has cardiac infarction occurred within past six months. 5)Patient has body cavity fluid which needs to be treated. 6)Patient has active infection. 7)Patient has serious coexisting illness (including diabetes which is difficult to control). 8)Patient has serious drug allergy. 9)Patient has serious psychiatric illness that can make his/her decisions unstable or uncertain. 10)Patient had had bone marrow transplantation or stem cell transplantation. 11)Patient has symptomatic brain metastasis. 12)Patient receives continuous whole-body administration of steroid drugs (orally or intravenously.) 13)Patient has active double cancer. 14)Patient is apparently/possibly during pregnancy, lactation expectant, or desiring future fertility in the period from informed consent day to 3 months after final test drug administration. 15)Patient has received unapproved drugs or other investigational drugs within 30 days before the registration date. 16)Patient is judged unsuitable as object of this clinical trial by the principal investigator or the physician in charge.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The optimal dosage is eventually decided by the frequency of dose limiting toxicities at the first course in each dose level.