Trial Outcomes & Findings for Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy (NCT NCT01990352)

NCT ID: NCT01990352

Last Updated: 2023-11-21

Results Overview

Evaluating if low BRCA1 protein expression has a preferential effect on response when metastatic breast cancer patients are treated with DNA damaging chemotherapy agent, compared to historical controls. Response rate is defined as the percentage of evaluable patients who achieve complete response (CR) or partial response (PR) as measured by RECIST 1.1 on CT or PET/CT as the best overall response.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Start of treatment and repeat imaging done at 9 weeks (± 7 days)
• Results posted on: 2023-11-21

Participant Flow

Participant milestones

Measure	Pegylated Liposomal Doxorubicin The enrolled patients will be treated with pegylated liposomal doxorubicin at 30mg/m2 every 21 days. Pegylated liposomal doxorubicin: Doxil will be administered intravenously at 30mg/m2 on days 1 of a 21 day cycle.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy

Baseline characteristics by cohort

Measure	Pegylated Liposomal Doxorubicin n=24 Participants The enrolled patients will be treated with pegylated liposomal doxorubicin at 30mg/m2 every 21 days. Pegylated liposomal doxorubicin: Doxil will be administered intravenously at 30mg/m2 on days 1 of a 21 day cycle.
Age, Customized <=69 years	18 Participants n=5 Participants
Age, Customized >=70 years	5 Participants n=5 Participants
Age, Customized Unknown	1 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	22 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	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Start of treatment and repeat imaging done at 9 weeks (± 7 days)

Population: The assay to evaluate BRCA1 protein expression failed to assess due to a multitude of reasons. It could not be validated, and the collaborator discontinued the assay's further development. Since were were not able to perform the BRCA1 protein expression, the analysis for overall response rate was not performed and we are unable to report any data.

Evaluating if low BRCA1 protein expression has a preferential effect on response when metastatic breast cancer patients are treated with DNA damaging chemotherapy agent, compared to historical controls. Response rate is defined as the percentage of evaluable patients who achieve complete response (CR) or partial response (PR) as measured by RECIST 1.1 on CT or PET/CT as the best overall response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Start of Treatment until the date of first documented progression or date of death, assessed up to an expected average of 100 weeks

Population: The assay to evaluate BRCA1 protein expression failed to assess due to a multitude of reasons. It could not be validated, and the collaborator discontinued the assay's further development. Since were were not able to perform the BRCA1 protein expression, the analysis for progression-free survival was not performed and we are unable to report any data.

Evaluating if low BRCA1 protein expression has a preferential effect on tumor progression when metastatic breast cancer patients are treated with DNA damaging chemotherapy agent, compared to historical controls. Progression free survival will be measured as the times from the start of pegylated liposomal doxorubicin to the time the patient is first recorded as having disease progression or dies. If a patient does not progress or die while being followed via tumor assessment, progression-free survival will be censored at the time of last disease assessment. The median progression free survival will be calculated in patients with low BRCA1 protein expression and intact BRCA1 protein expression. Median progression free survival will be estimated by Kaplan-Meier methodology

Outcome measures

Outcome data not reported

Adverse Events

Pegylated Liposomal Doxorubicin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pavani Chalasani

George Washington Cancer Center

Phone: (202)-741-2277

Email: pavani.chalasani@email.gwu.edu

Results disclosure agreements

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