Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2
CompletedPhase 2Results postedLast updated 22 September 2021
What this trial tests
Phase 2 trial testing Paclitaxel in Breast Cancer in 54 participants. Completed in 4 November 2020.
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pathologic Complete Response (pCR)Primary· 4 -6 weeks from last dose of FAC/FEC-regimen.
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.
Group
Value
95% CI
Paclitaxel Weekly for 12 Doses Followed by FAC/FEC
7
Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC
1
5 Year Event Free Survival (EFS)Secondary· 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.
Group
Value
95% CI
Paclitaxel Weekly for 12 Doses Followed by FAC/FEC
81.8
Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC
74
Overall Survival (OS)Secondary· from start of treatment, up to 5 years
Group
Value
95% CI
Paclitaxel Weekly for 12 Doses Followed by FAC/FEC
100
Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC
84.4
Adverse events — posted to ClinicalTrials.gov
Time frame: 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.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Paclitaxel Weekly for 12 Doses Followed by FAC/FEC
Serious: 3/28 (11%)
Deaths: 0/28
Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC
The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. In this study, the standard chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).
Eribulin is a changed version of the structure of a natural substance from a sea sponge. It is designed to block cells from dividing, which may cause cancer cells to die.
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die.
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and/or keep them from spreading throughout the body. This may cause the cancer cells to die.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 22 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01593020.