UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase1 trial of weekly paclitaxel and gemcitabine in previously anthracycline-treated patients with locally advanced or metastatic breast cancer (SBCCSG-17)
Title of the study (Brief title)	Phase1 trial of weekly paclitaxel and gemcitabine
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The dosing history of anti-cancer drug decides dosage of weekly gemcitabine and paclitaxel using together intended for patients with locally advanced and metastatic breast cancer and safety is verified.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The optimal dosage is eventually decided by the frequency of dose limiting toxicities at the first course in each dose level.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Female
Key inclusion criteria	1)Patient is histologically or cytologically confirmed as locally advanced or metastatic breast cancer. 2)Patient who had relapsed after receiving anthracycline-based chemotherapy regimen. Taxanes must have been completed more than 6 months. 3)Patient who have passed the following periods from previous treatment completion date: A.Immunotherapy/endocrinotherapy; at least 14 days from the final administration date (Slow-release formulations of LH-RH agonist needs at least 28 days). B.Chemotherapy; at least 28 days from the final administration date. C.Radiotherapy; at least 28 days from the final treatment date. D.Treatment with antibodies; at least 28 days from the final administration date. 4)Patient has received radiation to not more than 20% of the bone marrow area. 5)There is no regulation concerning the hormonal therapy. 6)Performance status (PS) 0-1. 7)Patient has adequate organ functions confirmed with following major examinations conducted within 14 days before each patient's registration. 8)Patient has given written informed consent.
Key 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.
Target sample size	12

Research contact person
Name of lead principal investigator	Shigenori Nagai
Organization	Saitama Cancer Center
Division name	Breast Medical Oncology
Address	818 Ina-machi oaza komuro, kita-adachi-gun, Saitama, 362-0806, Japan
TEL
Email

Public contact
Name of contact person	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Secretariat Division (Shintoshin Ladies' MammoClinic)
Address	3F Captal building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@sbccsg.org

Sponsor
Institute	Saitama Breast Cancer Clinical Study Group(SBCCSG)
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 20 Day
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	The optimal dosage is eventually decided by the frequency of dose limiting toxicities at the first course in each dose level.

Management information
Registered date	2010 Year 08 Month 22 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004920