Trial Outcomes & Findings for Doxorubicin Hydrochloride, Cyclophosphamide, and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery (NCT NCT00407888)

NCT ID: NCT00407888

Last Updated: 2017-08-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-08-31

Participant Flow

Participant milestones

Measure	Arm I Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity. doxorubicin hydrochloride: Given IV cyclophosphamide: Given orally filgrastim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Doxorubicin Hydrochloride, Cyclophosphamide, and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery

Baseline characteristics by cohort

Measure	Arm I n=60 Participants Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity. doxorubicin hydrochloride: Given IV cyclophosphamide: Given orally filgrastim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure

Arm I n=60 Participants Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity. doxorubicin hydrochloride: Given IV cyclophosphamide: Given orally filgrastim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies

Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin

56 Participants

SECONDARY outcome

Timeframe: After at least one course of Adriamycin, up to 12 weeks.

Outcome measures

Measure	Arm I n=60 Participants Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity. doxorubicin hydrochloride: Given IV cyclophosphamide: Given orally filgrastim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies
Delivered Dose Intensity of the Regimen Doxorubicin	92.6 percentage of mean administered dose
Delivered Dose Intensity of the Regimen Cyclophosphamide	92.1 percentage of mean administered dose
Delivered Dose Intensity of the Regimen nP (intent-to-treat)	88.0 percentage of mean administered dose

SECONDARY outcome

Timeframe: After at least one course of Adriamycin, up to 12 weeks.

Population: Some results reported are only considered amongst patients receiving Trastuzumab (n = 15).

Outcome measures

Measure	Arm I n=60 Participants Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity. doxorubicin hydrochloride: Given IV cyclophosphamide: Given orally filgrastim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies
Toxicity Associated With This Regimen Filgrastim used	37 Participants
Toxicity Associated With This Regimen Dose holds/reductions	43 Participants
Toxicity Associated With This Regimen Hospitalization/ER evaluation	5 Participants
Toxicity Associated With This Regimen Trastuzumab patients with decease in LVEF to <50%	2 Participants
Toxicity Associated With This Regimen Trastuzumab patients with decease in LVEF to <10%	3 Participants

SECONDARY outcome

Timeframe: Up to 6 years

Population: Outcome measure reported only for those that had an event (death, recurrent disease or removal).

Median time from date of start of therapy to date of removal from therapy for reason other than completion, date of first observation of recurrent disease or date of death due to any cause whichever comes first.

Outcome measures

Measure

Arm I n=11 Participants Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity. doxorubicin hydrochloride: Given IV cyclophosphamide: Given orally filgrastim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies

Time to Treatment Failure

2.7 years Interval 0.2 to 4.2

SECONDARY outcome

Timeframe: Up to 6 years.

Count of surviving patients at two years and six years

Outcome measures

Measure	Arm I n=60 Participants Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity. doxorubicin hydrochloride: Given IV cyclophosphamide: Given orally filgrastim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies
Overall Survival Two years	59 Participants
Overall Survival Six years	53 Participants

Adverse Events

Arm I

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=60 participants at risk Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity. doxorubicin hydrochloride: Given IV cyclophosphamide: Given orally filgrastim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies
Gastrointestinal disorders Hemorrhoidal Hemorrhage	1.7% 1/60
General disorders Fever	1.7% 1/60
Infections and infestations Possible Pneumoncystis Pneumonia	1.7% 1/60
Respiratory, thoracic and mediastinal disorders Pneumothorax due to MVA	1.7% 1/60
Blood and lymphatic system disorders Febrile Neutopenia	1.7% 1/60
Respiratory, thoracic and mediastinal disorders Shortness of Breath	1.7% 1/60
Gastrointestinal disorders Mucositis	1.7% 1/60
Metabolism and nutrition disorders Dehydration	1.7% 1/60
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	1.7% 1/60

Other adverse events

Measure	Arm I n=60 participants at risk Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity. doxorubicin hydrochloride: Given IV cyclophosphamide: Given orally filgrastim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies
Investigations Neutropenia	55.0% 33/60
Gastrointestinal disorders Nausea	5.0% 3/60
Investigations Leukopenia	5.0% 3/60
Renal and urinary disorders Low Hemoglobin	5.0% 3/60
Nervous system disorders Neuropathy	6.7% 4/60
Gastrointestinal disorders Mucositis	10.0% 6/60
Skin and subcutaneous tissue disorders Hand Foot Syndrome	8.3% 5/60

Additional Information

Hannah Linden MD FACP

Medical Oncology University of Washington

Phone: 206-288-6989

Email: hmlinden@uw.edu

Results disclosure agreements

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