A Phase 2 interventional study of Paclitaxel in Breast Cancer, sponsored by Bristol-Myers Squibb. Completed at 4 sites in Japan. Open to female participants. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
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)"
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 6 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Drug: Paclitaxel
Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Also known as: Taxol, BMS-181339
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)
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)
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)
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)
| Milestone | Treatment Arm |
|---|---|
| Started | 6 |
| Completed | 0 |
| Not completed | 6 |
| Withdrew: Progressive disease | 3 |
| Withdrew: Change in treatment policy | 1 |
| Withdrew: Other reasons | 2 |
This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)
| Participants | Treatment Arm |
|---|---|
| Number of Participants Experiencing Adverse Events | 6 |
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
| Participants | Treatment Arm |
|---|---|
| Hematology investigations | 1 |
| Lipid analyses | 1 |
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."
| Participants | Treatment Arm |
|---|---|
| Overall Response Rate (ORR) | 5 |
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.
| Days | Treatment Arm |
|---|---|
| Duration of Response (DOR) | 840 (229 to 1156) |
Collected over From first dose to 14 days following last dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| Event | Treatment Arm |
|---|---|
| NauseaGastrointestinal disorders | 1/6 |
| VomitingGastrointestinal disorders | 1/6 |
| Femur fractureInjury, poisoning and procedural complications | 1/6 |
| Event | Treatment Arm |
|---|---|
| HypoaesthesiaNervous system disorders | 6/6 |
| AlopeciaSkin and subcutaneous tissue disorders | 6/6 |
| OedemaGeneral disorders | 5/6 |
| FatigueGeneral disorders | 4/6 |
| NasopharyngitisInfections and infestations | 4/6 |
| MyalgiaMusculoskeletal and connective tissue disorders | 4/6 |
| Nail disorderSkin and subcutaneous tissue disorders | 4/6 |
| ConstipationGastrointestinal disorders | 3/6 |
| StomatitisGastrointestinal disorders | 3/6 |
| Weight increasedInvestigations | 3/6 |
| Age, Continuous(Years) | Treatment Arm |
|---|---|
| Median | 46.0 (33 to 53) |
| Sex: Female, Male(Participants) | Treatment Arm |
|---|---|
| Female | 6 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Arm |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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