NCT00971945

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

Completed Phase 2 Results posted Last updated 25 May 2021

What this trial tests

Phase 2 trial testing Paclitaxel in Breast Cancer in 6 participants. Completed in 31 March 2008.

Timeline

30 June 2005

Primary endpoint
31 March 2008

31 March 2008

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	30 June 2005
Primary completion	31 March 2008
Estimated completion	31 March 2008
Sites	4 locations across Japan

Drugs / interventions tested

• Paclitaxel — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Eligibility, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Experiencing Adverse Events Primary · 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)

Group	Value	95% CI
Treatment Arm	6

Number of Participants Experiencing Laboratory Tests Abnormalities Primary · 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 abnor

Hematology investigations

Group	Value	95% CI
Treatment Arm	1

Lipid analyses

Group	Value	95% CI
Treatment Arm	1

Overall Response Rate (ORR) Secondary · 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."

Group	Value	95% CI
Treatment Arm	5

Duration of Response (DOR) Secondary · 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.

Group	Value	95% CI
Treatment Arm	840	229 – 1156

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose to 14 days following last dose. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm

Serious: 2/6 (33%)

Deaths: 0/6

Serious adverse events (3 terms)

Reaction	System	Treatment Arm
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Femur fracture	Injury, poisoning and procedural complications	—

Other adverse events (66 terms — click to expand)

Reaction	System	Treatment Arm
Hypoaesthesia	Nervous system disorders	—
Alopecia	Skin and subcutaneous tissue disorders	—
Oedema	General disorders	—
Fatigue	General disorders	—
Nasopharyngitis	Infections and infestations	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Nail disorder	Skin and subcutaneous tissue disorders	—
Constipation	Gastrointestinal disorders	—
Stomatitis	Gastrointestinal disorders	—
Weight increased	Investigations	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Lacrimation increased	Eye disorders	—
Diarrhoea	Gastrointestinal disorders	—
Asthenia	General disorders	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Ear pain	Ear and labyrinth disorders	—
Adrenal haemorrage	Endocrine disorders	—
Conjunctival haemorrage	Eye disorders	—
Vision blurred	Eye disorders	—
Xerophthalmia	Eye disorders	—
Dacryostenosis acquired	Eye disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Dental caries	Gastrointestinal disorders	—
Haemorrhoids	Gastrointestinal disorders	—
Chest discomfort	General disorders	—
Pain	General disorders	—
Seasonal allergy	Immune system disorders	—
Cellulitis	Infections and infestations	—
Cystitis	Infections and infestations	—
Folliculitis	Infections and infestations	—
Paronychia	Infections and infestations	—
Pharyngitis	Infections and infestations	—
Pneumonia mycoplasmal	Infections and infestations	—
Rhinitis	Infections and infestations	—
Purulence	Infections and infestations	—
Arthropod sting	Injury, poisoning and procedural complications	—
Contusion	Injury, poisoning and procedural complications	—
Wound	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Nausea, Vomiting, Femur fracture.

Data from ClinicalTrials.gov NCT00971945 adverse events section.

Sponsor's own description

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)"

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.