Trial Outcomes & Findings for Neo-Adjuvant Study in Triple Negative Breast Cancer Patients (NCT NCT01097642)
NCT ID: NCT01097642
Last Updated: 2021-09-22
Results Overview
The study's primary objective is to determine the pathologic complete response rate (pCR) (breast and axilla) of Ixabepilone versus Ixabepilone when combined with cetuximab in patients with invasive breast adenocarcinoma T1N1-N3M0 or T2-4 N0-3M0 disease who are triple negative and who are candidates for preoperative chemotherapy. The criteria used: "Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
COMPLETED
PHASE2
40 participants
one year after treatment
2021-09-22
Participant Flow
Participant milestones
| Measure |
Ixabepilone
Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
Ixabepilone Plus Cetuximab
Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.
Cetuximab: Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
25
|
|
Overall Study
COMPLETED
|
15
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neo-Adjuvant Study in Triple Negative Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Ixabepilone
n=15 Participants
Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
Ixabepilone Plus Cetuximab
n=25 Participants
Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.
Cetuximab: Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
57 years
n=7 Participants
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Triple Negative Negative Breast Cancer (T1N1-N3M0 or T2-4 N0-3M0)
|
14 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one year after treatmentThe study's primary objective is to determine the pathologic complete response rate (pCR) (breast and axilla) of Ixabepilone versus Ixabepilone when combined with cetuximab in patients with invasive breast adenocarcinoma T1N1-N3M0 or T2-4 N0-3M0 disease who are triple negative and who are candidates for preoperative chemotherapy. The criteria used: "Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Outcome measures
| Measure |
Ixabepilone Plus Cetuximab
n=25 Participants
Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.
Cetuximab: Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
Ixabepilone
n=15 Participants
Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
|---|---|---|
|
Complete Response Rate
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Median 3-yearThe secondary objective is to evaluate the RFS in both treatment groups. The criteria used: "Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Outcome measures
| Measure |
Ixabepilone Plus Cetuximab
n=25 Participants
Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.
Cetuximab: Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
Ixabepilone
n=15 Participants
Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
|---|---|---|
|
Recurrence Free Survival (RFS)
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: one year after last treatment doseThe number of participants with adverse events will be measured. Toxicity/safety will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0). Baseline signs and symptoms will be recorded and followed throughout the trial. Toxicity assessments will be continuous during treatment and the year of follow-up, after which all study drug-related toxicities will be deemed resolved, stabilized, or irreversible. Vital signs will be performed at baseline and will be monitored pre-dose and during study drug administration for Cycles 1 - 4. Chemistry and hematology laboratory tests will be done at baseline and prior to each subsequent chemotherapy cycle.
Outcome measures
| Measure |
Ixabepilone Plus Cetuximab
n=25 Participants
Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.
Cetuximab: Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
Ixabepilone
n=15 Participants
Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
|---|---|---|
|
Safety and Toxicity of Both Treatment Regimens: Number of Participants With Adverse Events
|
25 Participants
|
15 Participants
|
Adverse Events
Ixabepilone
Ixabepilone Plus Cetuximab
Serious adverse events
| Measure |
Ixabepilone
n=15 participants at risk
Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
Ixabepilone Plus Cetuximab
n=25 participants at risk
Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.
Cetuximab: Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
|---|---|---|
|
Nervous system disorders
Peripheral neuropathy
|
13.3%
2/15 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
8.0%
2/25 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
4.0%
1/25 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
|
Gastrointestinal disorders
GI Events
|
0.00%
0/15 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
4.0%
1/25 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
8.0%
2/25 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
Other adverse events
| Measure |
Ixabepilone
n=15 participants at risk
Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
Ixabepilone Plus Cetuximab
n=25 participants at risk
Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.
Cetuximab: Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.
Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
73.3%
11/15 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
72.0%
18/25 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
|
General disorders
Fatigue
|
66.7%
10/15 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
84.0%
21/25 • Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
|
Additional Information
Dr. Jenny Chang
The Methodist Hospital Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place