Trial Outcomes & Findings for Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer (NCT NCT00574236)

Last Updated: 2019-12-13

Results Overview

Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Every two cycles/42 days, up to 7 months

Results posted on

2019-12-13

Participant Flow

This study enrolled subjects with metastatic breast cancer from the Wisconsin Oncology Network (WON), which is driven by investigators at the University of Wisconsin Carbone Cancer Center, from August of 2006 through February of 2008.

Participant milestones

Participant milestones
Measure	Bortezomib and Doxorubicin Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bortezomib and Doxorubicin n=4 Participants Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 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
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every two cycles/42 days, up to 7 months

Population: Protocol accrued only 4 of 54 subjects, and was ultimately terminated. No data analysis was done.

Outcome measures

Outcome measures
Measure	Bortezomib and Doxorubicin n=4 Participants Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
Overall Response Rate Complete Response	0 Participants
Overall Response Rate Partial Response	1 Participants
Overall Response Rate Progressive Disease	3 Participants

SECONDARY outcome

Timeframe: Up to one year

Number of days to progression, where progression is defined as the number of days from the day of first study drug administration to the day the patient experiences an event of disease progression, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. If a patient has not experienced an event of disease progression, then the patient's data will be censored at the date of the last available evaluation. Progression-free survival will be summarized by medium time to progression.

Outcome measures

Outcome measures
Measure	Bortezomib and Doxorubicin n=4 Participants Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
Time to Progression	47 days to progression Interval 41.0 to 210.0

Adverse Events

Bortezomib and Doxorubicin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bortezomib and Doxorubicin n=4 participants at risk Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Gastrointestinal disorders Anorexia	50.0% 2/4 • Number of events 3 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Gastrointestinal disorders Constipation	100.0% 4/4 • Number of events 5 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Gastrointestinal disorders Diarrhea	50.0% 2/4 • Number of events 2 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Nervous system disorders Dizziness	50.0% 2/4 • Number of events 2 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
General disorders Fatigue (asthenia, lethargy, malaise)	75.0% 3/4 • Number of events 5 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	75.0% 3/4 • Number of events 3 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Gastrointestinal disorders Heartburn/dyspepsia	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Blood and lymphatic system disorders Hemoglobin	25.0% 1/4 • Number of events 2 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Ungual (nails)	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
General disorders Insomnia	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Blood and lymphatic system disorders Leukocytes (total WBC)	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Nervous system disorders Mood alteration: Depression	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - Oral cavity	25.0% 1/4 • Number of events 2 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Skin and subcutaneous tissue disorders Nail changes	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Gastrointestinal disorders Nausea	100.0% 4/4 • Number of events 6 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Nervous system disorders Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Nervous system disorders Neuropathy: sensory	75.0% 3/4 • Number of events 5 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	50.0% 2/4 • Number of events 2 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
General disorders Pain	100.0% 4/4 • Number of events 9 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
General disorders Sweating (diaphoresis)	25.0% 1/4 • Number of events 1 • Adverse event data were collected for 1 year, 9 months. Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.

Additional Information

Dr. Anne Traynor

University of Wisconsin Carbone Cancer Center

Phone: 608-262-5092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place