Trial Outcomes & Findings for S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer (NCT NCT00041067)

NCT ID: NCT00041067

Last Updated: 2013-06-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 76 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2013-06-06

Participant Flow

During the period February 2003 to December 2006, 76 patients were enrolled at 28 SWOG institutions.

Participant milestones

Measure	Trastuzumab, Docetaxel, Vinorelbine and Filgrastim Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel : 60 mg/m\^2 on Day 1 of 21-day cycles vinorelbine : 27.5 mg/m\^2 on Days 8 and 15 filgrastim : 5 microg/kg/day on Days 2 to 21 trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period
Overall Study STARTED	76
Overall Study Eligible	74
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	76

Reasons for withdrawal

Measure	Trastuzumab, Docetaxel, Vinorelbine and Filgrastim Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel : 60 mg/m\^2 on Day 1 of 21-day cycles vinorelbine : 27.5 mg/m\^2 on Days 8 and 15 filgrastim : 5 microg/kg/day on Days 2 to 21 trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period
Overall Study Adverse Event	20
Overall Study Progression	19
Overall Study Patient refusal	12
Overall Study Other reasons	23
Overall Study Ineligible	2

Baseline Characteristics

S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer

Baseline characteristics by cohort

Measure	Trastuzumab, Docetaxel, Vinorelbine and Filgrastim n=74 Participants Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel : 60 mg/m\^2 on Day 1 of 21-day cycles vinorelbine : 27.5 mg/m\^2 on Days 8 and 15 filgrastim : 5 microg/kg/day on Days 2 to 21 trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period
Age, Customized 30-39	11 participants n=93 Participants
Age, Customized 40-49	26 participants n=93 Participants
Age, Customized 50-59	19 participants n=93 Participants
Age, Customized 60-69	15 participants n=93 Participants
Age, Customized 70-79	3 participants n=93 Participants
Sex: Female, Male Female	74 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All eligible patients

Outcome measures

Measure	Trastuzumab, Docetaxel, Vinorelbine and Filgrastim n=74 Participants Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel : 60 mg/m\^2 on Day 1 of 21-day cycles vinorelbine : 27.5 mg/m\^2 on Days 8 and 15 filgrastim : 5 microg/kg/day on Days 2 to 21 trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period
Survival at 1 Year	93 percentage of patients Interval 84.0 to 97.0

SECONDARY outcome

Timeframe: response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession

Population: patients with Response Evaluation Criteria in Solid Tumors measurable disease

Response was measured by the RECIST criteria. A patient was considered a responder if there was confirmed or unconfirmed partial or complete response. All others were considered non-responders even if the patient was technically not assessable due to different measurement techniques at the two time points.

Outcome measures

Measure	Trastuzumab, Docetaxel, Vinorelbine and Filgrastim n=63 Participants Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel : 60 mg/m\^2 on Day 1 of 21-day cycles vinorelbine : 27.5 mg/m\^2 on Days 8 and 15 filgrastim : 5 microg/kg/day on Days 2 to 21 trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period
Response Rate (Complete and Partial, Confirmed and Unconfirmed)	53 participants Interval 63.0 to 84.0

SECONDARY outcome

Timeframe: 2 years

Population: All eligible patients

Outcome measures

Measure	Trastuzumab, Docetaxel, Vinorelbine and Filgrastim n=74 Participants Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel : 60 mg/m\^2 on Day 1 of 21-day cycles vinorelbine : 27.5 mg/m\^2 on Days 8 and 15 filgrastim : 5 microg/kg/day on Days 2 to 21 trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period
Progression-free Survival	20 months Interval 15.0 to 28.0

SECONDARY outcome

Timeframe: toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession

Population: Eligible patients

Number of patients for whom highest grade of toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Measure	Trastuzumab, Docetaxel, Vinorelbine and Filgrastim n=73 Participants Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel : 60 mg/m\^2 on Day 1 of 21-day cycles vinorelbine : 27.5 mg/m\^2 on Days 8 and 15 filgrastim : 5 microg/kg/day on Days 2 to 21 trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period
Toxicity Alkaline phosphatase increase	1 Participants
Toxicity Anemia	7 Participants
Toxicity Arthralgia	1 Participants
Toxicity Bone pain	2 Participants
Toxicity Catheter related infection	2 Participants
Toxicity Chest pain,not cardio or pleur	2 Participants
Toxicity Dehydration	1 Participants
Toxicity Depression	1 Participants
Toxicity Diarrhea without colostomy	2 Participants
Toxicity Dyspepsia/heartburn	1 Participants
Toxicity Dyspnea	2 Participants
Toxicity Fatigue/malaise/lethargy	9 Participants
Toxicity Febrile neutropenia	4 Participants
Toxicity Headache	3 Participants
Toxicity Hyperglycemia	6 Participants
Toxicity Hypermagnesemia	1 Participants
Toxicity Hypokalemia	2 Participants
Toxicity Hypophosphatemia	1 Participants
Toxicity Hypotension	1 Participants
Toxicity Hypoxia	1 Participants
Toxicity Infection w/o 3-4 neutropenia	4 Participants
Toxicity Infection with 3-4 neutropenia	1 Participants
Toxicity LVEF decrease/CHF	1 Participants
Toxicity Leukopenia	11 Participants
Toxicity Lymphopenia	2 Participants
Toxicity Muscle weakness (not neuro)	1 Participants
Toxicity Nausea	3 Participants
Toxicity Neutropenia/granulocytopenia	16 Participants
Toxicity PRBC transfusion	1 Participants
Toxicity Pain-other	3 Participants
Toxicity Pericar. effusion/pericarditis	1 Participants
Toxicity Pneumonitis/infiltrates	3 Participants
Toxicity Respiratory infect w/ neutrop	1 Participants
Toxicity Respiratory infection, unk ANC	1 Participants
Toxicity SGPT (ALT) increase	1 Participants
Toxicity Syncope	1 Participants
Toxicity Tearing	1 Participants
Toxicity Thrombosis/embolism	1 Participants
Toxicity Transplant-pRBC transfusion	1 Participants
Toxicity Vomiting	2 Participants
Toxicity Sensory neuropathy	5 Participants

Adverse Events

Docetaxel + Vinorelbine + G-CSF + Trastuzumab

Serious events: 0 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Docetaxel + Vinorelbine + G-CSF + Trastuzumab n=73 participants at risk
Blood and lymphatic system disorders Anemia	80.8% 59/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Blood and lymphatic system disorders Febrile neutropenia	5.5% 4/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Cardiac disorders LVEF decrease/CHF	5.5% 4/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Eye disorders Conjunctivitis	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Eye disorders Eye-other	5.5% 4/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Eye disorders Tearing	20.5% 15/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Gastrointestinal disorders Abdominal pain/cramping	5.5% 4/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Gastrointestinal disorders Constipation/bowel obstruction	21.9% 16/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Gastrointestinal disorders Diarrhea without colostomy	43.8% 32/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Gastrointestinal disorders Dyspepsia/heartburn	11.0% 8/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Gastrointestinal disorders Nausea	35.6% 26/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Gastrointestinal disorders Stomatitis/pharyngitis	27.4% 20/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Gastrointestinal disorders Vomiting	16.4% 12/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
General disorders Edema	24.7% 18/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
General disorders Fatigue/malaise/lethargy	86.3% 63/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
General disorders Fever without neutropenia	15.1% 11/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
General disorders Pain-other	20.5% 15/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
General disorders Rigors/chills	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Infections and infestations Infection w/o 3-4 neutropenia	16.4% 12/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Investigations Alkaline phosphatase increase	54.8% 40/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Investigations Bilirubin increase	5.5% 4/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Investigations Leukopenia	31.5% 23/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Investigations Neutropenia/granulocytopenia	32.9% 24/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Investigations SGOT (AST) increase	23.3% 17/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Investigations SGPT (ALT) increase	19.2% 14/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Investigations Thrombocytopenia	12.3% 9/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Investigations Weight loss	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Metabolism and nutrition disorders Anorexia	16.4% 12/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Metabolism and nutrition disorders Dehydration	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Metabolism and nutrition disorders Hypercalcemia	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Metabolism and nutrition disorders Hyperglycemia	26.0% 19/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Metabolism and nutrition disorders Hypocalcemia	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Metabolism and nutrition disorders Hypokalemia	9.6% 7/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Musculoskeletal and connective tissue disorders Arthralgia	19.2% 14/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Musculoskeletal and connective tissue disorders Bone pain	45.2% 33/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Musculoskeletal and connective tissue disorders Chest pain,not cardio or pleur	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Musculoskeletal and connective tissue disorders Muscle weakness (not neuro)	11.0% 8/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Musculoskeletal and connective tissue disorders Myalgia	32.9% 24/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Nervous system disorders Dizziness/light headedness	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Nervous system disorders Headache	20.5% 15/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Nervous system disorders Neuropathic pain	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Nervous system disorders Sensory neuropathy	47.9% 35/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Nervous system disorders Taste disturbance	16.4% 12/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Psychiatric disorders Anxiety/agitation	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Psychiatric disorders Depression	5.5% 4/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Psychiatric disorders Insomnia	21.9% 16/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Renal and urinary disorders Dysuria	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	11.0% 8/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Respiratory, thoracic and mediastinal disorders Cough	15.1% 11/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.5% 15/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.2% 6/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Respiratory, thoracic and mediastinal disorders Pneumonitis/infiltrates	5.5% 4/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Skin and subcutaneous tissue disorders Alopecia	58.9% 43/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Skin and subcutaneous tissue disorders Nail changes	21.9% 16/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Skin and subcutaneous tissue disorders Rash/desquamation	17.8% 13/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Vascular disorders Hot flashes	8.2% 6/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Vascular disorders Hypotension	6.8% 5/73 • Every 3 weeks for up to 3 years. Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.

Additional Information

Study statistician

SWOG

Phone: 206-667-4623

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place