Trial Outcomes & Findings for Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer (NCT NCT00608972)

NCT ID: NCT00608972

Last Updated: 2023-02-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: Two Years
• Results posted on: 2023-02-08

Participant Flow

Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. They study was open to accrual on 05/16/2008 and closed to accrual on 12/31/2012.

We are reporting results on 31 eligible patients.

Participant milestones

Measure	Doxil, Carboplatin and Bevacizumab Doxil: Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Carboplatin: Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Bevacizumab: Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Overall Study STARTED	31
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Doxil, Carboplatin and Bevacizumab n=31 Participants Doxil: Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Carboplatin: Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Bevacizumab: Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 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	6 Participants n=5 Participants
Race (NIH/OMB) White	21 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	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Two Years

Outcome measures

Measure	Doxil, Carboplatin and Bevacizumab n=31 Participants Doxil: Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Carboplatin: Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Bevacizumab: Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer	6 participants

SECONDARY outcome

Timeframe: up to two years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Doxil, Carboplatin and Bevacizumab n=31 Participants Doxil: Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Carboplatin: Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Bevacizumab: Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Clinical Benefit Rate (CBR=CR+PR+SD)	13 Participants

SECONDARY outcome

Timeframe: one year

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Doxil, Carboplatin and Bevacizumab n=31 Participants Doxil: Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Carboplatin: Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Bevacizumab: Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
One-year Progression-free Survival	31 participants Interval 29.5 to 65.1

SECONDARY outcome

Timeframe: From date of randomization up to two years

median overall survival

Outcome measures

Measure	Doxil, Carboplatin and Bevacizumab n=31 Participants Doxil: Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Carboplatin: Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Bevacizumab: Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative	11 months Interval 8.8 to 21.8

SECONDARY outcome

Timeframe: six months

Six-month survival rate

Outcome measures

Measure	Doxil, Carboplatin and Bevacizumab n=31 Participants Doxil: Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Carboplatin: Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Bevacizumab: Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative	41.9 Percentage participants Interval 24.6 to 59.3

Adverse Events

Doxil, Carboplatin and Bevacizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 28 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deborah L Toppmeyer, M.D.

Rutgers Cancer Institute of New Jersey

Phone: 732-235-6789

Email: toppmede@cinj.rutgers.edu

Results disclosure agreements

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