Breast Cancer
Conditions
Brief 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)
Interventions
DRUGPaclitaxel
Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events | From first dose to end of follow-up period (up to approximately 33 months) | This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively) |
| Number of Participants Experiencing Laboratory Tests Abnormalities | From first dose to end of follow-up period (up to approximately 33 months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | From first dose to end of follow-up period (up to approximately 33 months) | 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. |
| Duration of Response (DOR) | 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) | 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. |
Countries
Japan
Participant flow
Pre-assignment details
Six participants were enrolled and treated.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days). | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Change in treatment policy | 1 |
| Overall Study | Other reasons | 2 |
| Overall Study | Progressive Disease | 3 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 46.0 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 2 / 6 |
Outcome results
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)
Time frame: From first dose to end of follow-up period (up to approximately 33 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Number of Participants Experiencing Adverse Events | 6 Participants |
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
Time frame: From first dose to end of follow-up period (up to approximately 33 months)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Arm | Number of Participants Experiencing Laboratory Tests Abnormalities | Hematology investigations | 1 Participants |
| Treatment Arm | Number of Participants Experiencing Laboratory Tests Abnormalities | Lipid analyses | 1 Participants |
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.
Time frame: 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)
Population: All treated participants (enrolled in study NCT01023204 and NCT00971945) with PR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Arm | Duration of Response (DOR) | 840 Days |
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.
Time frame: From first dose to end of follow-up period (up to approximately 33 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Overall Response Rate (ORR) | 5 Participants |