Trial Outcomes & Findings for Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer (NCT NCT01498588)
NCT ID: NCT01498588
Last Updated: 2016-10-03
Results Overview
Patients will receive treatment for 20 weeks with primary outcome measured at the time of surgery. Surgery is typically 4-6 weeks after completion of chemotherapy, so patients will be on study for 24 weeks on average. Response was measured by pathologist's standard of care assessment of extent of residual disease. If the patient had no evidence of invasive or in situ residual disease present in the breast and lymph node (i.e. ypT0N0), then this was defined as a pathologic complete response (pCR). Reported is the number of participants showing pCR.
TERMINATED
PHASE2
7 participants
Average of 24 weeks
2016-10-03
Participant Flow
This study was open to accrual from October 2011 to June 2015. Enrolled participants were from Winship Cancer Institute of Emory University and Emory University Hospital Midtown.
Participant milestones
| Measure |
Eribulin+Doxorubicin+Cyclophosphamide
Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Eribulin+Doxorubicin+Cyclophosphamide
n=7 Participants
Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 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
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average of 24 weeksPopulation: Pathology information at the time of definitive resection was available for six of seven patients. One patient was ultimately lost to follow-up.
Patients will receive treatment for 20 weeks with primary outcome measured at the time of surgery. Surgery is typically 4-6 weeks after completion of chemotherapy, so patients will be on study for 24 weeks on average. Response was measured by pathologist's standard of care assessment of extent of residual disease. If the patient had no evidence of invasive or in situ residual disease present in the breast and lymph node (i.e. ypT0N0), then this was defined as a pathologic complete response (pCR). Reported is the number of participants showing pCR.
Outcome measures
| Measure |
Eribulin+Doxorubicin+Cyclophosphamide
n=7 Participants
Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy
|
|---|---|
|
Pathologic Complete Response Rate at the Time of Surgery
Pathologic Complete Response (pCR)
|
1 participants
|
|
Pathologic Complete Response Rate at the Time of Surgery
No pCR
|
5 participants
|
|
Pathologic Complete Response Rate at the Time of Surgery
Unknown
|
1 participants
|
SECONDARY outcome
Timeframe: Through 20 weeks of chemotherapyToxicity of chemotherapy at each physician visit using Common Toxicity Criteria for Adverse Effects (CTCAE) criteria.
Outcome measures
| Measure |
Eribulin+Doxorubicin+Cyclophosphamide
n=7 Participants
Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy
|
|---|---|
|
Toxicity of Chemotherapy Regimen (Number of Participants With Any Adverse Events)
|
2 participants
|
Adverse Events
Eribulin+Doxorubicin+Cyclophosphamide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eribulin+Doxorubicin+Cyclophosphamide
n=7 participants at risk
Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy
|
|---|---|
|
General disorders
Fatigue
|
14.3%
1/7
|
|
General disorders
Insomnia
|
14.3%
1/7
|
|
Nervous system disorders
Neuropathy
|
28.6%
2/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7
|
|
Gastrointestinal disorders
Anorexia
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Hemorrhage
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Elevated ALT
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Elevated AST
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place