Trial Outcomes & Findings for Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2 (NCT NCT01593020)

Last Updated: 2021-09-22

Results Overview

Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

4 -6 weeks from last dose of FAC/FEC-regimen.

Results posted on

2021-09-22

Participant Flow

Patients were recruited from August 2012 to July 2014. This study was conducted at the University of Texas MD Anderson Cancer Center main campus and the Regional Care Centers (RCC).

54 patients were accrued. 28 patients were randomized to Paclitaxel and 26 patients to Eribulin group. 2 patients from eribulin were found ineligible and never received treatment and 1 patient withdrew due to physician decision.

Participant milestones

Participant milestones
Measure	Paclitaxel Weekly for 12 Doses Followed by FAC/FEC Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.	Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
Overall Study STARTED	28	23
Overall Study COMPLETED	26	21
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Paclitaxel Weekly for 12 Doses Followed by FAC/FEC Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.	Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
Overall Study Adverse Event	1	1
Overall Study Death	0	1
Overall Study Ineligible	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paclitaxel Weekly for 12 Doses Followed by FAC/FEC n=28 Participants Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.	Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC n=23 Participants Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=28 Participants	0 Participants n=23 Participants	0 Participants n=51 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=28 Participants	20 Participants n=23 Participants	48 Participants n=51 Participants
Age, Categorical >=65 years	0 Participants n=28 Participants	3 Participants n=23 Participants	3 Participants n=51 Participants
Sex: Female, Male Female	28 Participants n=28 Participants	23 Participants n=23 Participants	51 Participants n=51 Participants
Sex: Female, Male Male	0 Participants n=28 Participants	0 Participants n=23 Participants	0 Participants n=51 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	28 participants n=28 Participants	23 participants n=23 Participants	51 participants n=51 Participants

PRIMARY outcome

Timeframe: 4 -6 weeks from last dose of FAC/FEC-regimen.

Outcome measures

Outcome measures
Measure	Paclitaxel Weekly for 12 Doses Followed by FAC/FEC n=26 Participants Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.	Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC n=21 Participants Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
Pathologic Complete Response (pCR)	7 Participants	1 Participants

SECONDARY outcome

Timeframe: from start of treatment, up to 5 years

Event free survival (EFS) the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.

Outcome measures

Outcome measures
Measure	Paclitaxel Weekly for 12 Doses Followed by FAC/FEC n=28 Participants Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.	Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC n=23 Participants Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
5 Year Event Free Survival (EFS)	81.8 percentage of participants	74 percentage of participants

SECONDARY outcome

Timeframe: from start of treatment, up to 5 years

Outcome measures

Outcome measures
Measure	Paclitaxel Weekly for 12 Doses Followed by FAC/FEC n=28 Participants Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.	Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC n=23 Participants Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
Overall Survival (OS)	100 percentage of participants	84.4 percentage of participants

Adverse Events

Paclitaxel Weekly for 12 Doses Followed by FAC/FEC

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC

Serious events: 9 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Paclitaxel Weekly for 12 Doses Followed by FAC/FEC n=28 participants at risk Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.	Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC n=23 participants at risk Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.
General disorders Fatigue	7.1% 2/28 • Number of events 2 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	4.3% 1/23 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Gastrointestinal disorders Nausea	3.6% 1/28 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	0.00% 0/23 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Blood and lymphatic system disorders Neutrophil count decreased	10.7% 3/28 • Number of events 3 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	39.1% 9/23 • Number of events 9 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Nervous system disorders Paresthesia	3.6% 1/28 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	0.00% 0/23 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/28 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	4.3% 1/23 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Gastrointestinal disorders Vomiting	0.00% 0/28 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	4.3% 1/23 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Hepatobiliary disorders Alanine aminotransferase increased	0.00% 0/28 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	4.3% 1/23 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.6% 1/28 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	0.00% 0/23 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Blood and lymphatic system disorders White blood cell decreased	0.00% 0/28 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	4.3% 1/23 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Hepatobiliary disorders Aspartate aminotransferase increased	0.00% 0/28 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	4.3% 1/23 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Nervous system disorders Dizziness	0.00% 0/28 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	4.3% 1/23 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported
Cardiac disorders Left ventricular systolic dysfunction	3.6% 1/28 • Number of events 1 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported	0.00% 0/23 • The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery Only \>/= grade 3 serious adverse events are reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Valero Vicente, Professor, Breast Medical Oncology

UT MD Anderson Cancer Center

Phone: (713) 563-0751

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place