Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971945
• Other study ID #: CA139-387
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2005
• Est. completion date: March 31, 2008

Study information

• Verified date: May 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of continued administration of paclitaxel given weekly in subjects considered to need to continue treatment after completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with Advanced Breast Cancer (Protocol No. CA139-371)"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 31, 2008
• Est. primary completion date: March 31, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Paclitaxel
Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent

Locations

Country	Name	City	State
Japan	Local Institution	Hiroshima-shi	Hiroshima
Japan	Local Institution	Kagoshima-shi	Kagoshima
Japan	Local Institution	Nagoya	Aichi
Japan	Local Institution	Toshima-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Adverse Events	This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)	From first dose to end of follow-up period (up to approximately 33 months)
Primary	Number of Participants Experiencing Laboratory Tests Abnormalities	This outcome describes the number of participants experiencing laboratory test abnormalities. The following laboratory test categories were analyzed: Enzyme investigations; Hematology investigations; Hepatobiliary investigations; Lipid investigations; Protein and chemistry analyses; Renal and urinary tract investigations; Water, electrolytes and mineral investigation. Laboratory test abnormalities were graded according to the NCI Common Toxicity Criteria version 2 (JCOG Version), resulting in a score from Grade 0 (Normal) to Grade 5 (Death due to toxicity).; Only laboratory test abnormalities with a Grade 3 or higher are reported	From first dose to end of follow-up period (up to approximately 33 months)
Secondary	Overall Response Rate (ORR)	ORR is defined as the number (percentage) of participants achieving either a Complete Response (CR) or Partial Response (PR) to therapy. CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of all target lesions (taking as reference the baseline sum LD).; Target Lesions were evaluated according to "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer."	From first dose to end of follow-up period (up to approximately 33 months)
Secondary	Duration of Response (DOR)	DOR is defined as the median time from the first date of Partial Response (assessed as per the "Evaluation Criteria on the Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer") to the first date of Progressive Disease. Participants were evaluated for DOR in 2 separate studies (NCT01023204 and NCT00971945). Results are representative of the cumulative DOR assessed in both studies.	From first date of Partial Response (in study NCT01023204) to first date of Progressive Disease (in study NCT01023204 or NCT00971945) (up to approximately 37 months)