Trial Outcomes & Findings for A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer (NCT NCT00674206)

Results Overview

A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

8 weeks

Results posted on

2013-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Study All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Study n=6 Participants All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
Age Continuous	55 participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	Gemcitabine and Oxaliplatin n=6 Participants All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m\^2 on Day 1 and Oxaliplatin 100 mg/m\^2 intravenously over 2 hours on Day 2.
Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease. Stable Disease	4 participants
Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease. Partial Response	2 participants

SECONDARY outcome

Timeframe: 132 weeks

The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived. Note: Not all patients started the study at the same time so the time frame is different from the full range. The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived.

Outcome measures

Outcome measures
Measure	Gemcitabine and Oxaliplatin n=6 Participants All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m\^2 on Day 1 and Oxaliplatin 100 mg/m\^2 intravenously over 2 hours on Day 2.
Overall Survival From Time of Study Entry	62 Weeks Interval 13.0 to 86.0

Adverse Events

Single Arm Study

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm Study n=6 participants at risk All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
Infections and infestations Infection	16.7% 1/6 • Number of events 6
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Number of events 6

Other adverse events

Other adverse events
Measure	Single Arm Study n=6 participants at risk All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
Blood and lymphatic system disorders Platelets	33.3% 2/6
Blood and lymphatic system disorders Hemoglobin	16.7% 1/6
Nervous system disorders Neuropathy	16.7% 1/6
General disorders Fatigue	16.7% 1/6
General disorders Nausea	33.3% 2/6

Additional Information

Dr. Amelia Zelnak

Emory University

Phone: 404-778-1900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place