Trial Outcomes & Findings for Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer (NCT NCT00866905)
NCT ID: NCT00866905
Last Updated: 2021-11-22
Results Overview
Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
6 months
Results posted on
2021-11-22
Participant Flow
Participant milestones
| Measure |
Ixabepilone/Cyclophosphamide
Ixabepilone: 40 mg/m2 via intraveous (IV) infusion over 3 hours
Cyclophosphamide: 600 mg/m2 via IV infusion per institutional guidelines
|
|---|---|
|
Overall Study
STARTED
|
168
|
|
Overall Study
COMPLETED
|
135
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm/Group 1
n=168 Participants
All patients who received at least one dose of treatment.
|
|---|---|
|
Age, Continuous
|
53 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: To be evaluable, patients had to undergo surgery after neoadjuvant therapy. Out of 168 patients, only 161 patients underwent surgery after neoadjuvant therapy and were included in this analysis.
Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.
Outcome measures
| Measure |
Ixabepilone/Cyclophosphamide
n=161 Participants
Systemic Therapy followed by surgery and possible radiation therapy
|
|---|---|
|
Pathologic Complete Response Rate (pCR)
|
27 participants
|
SECONDARY outcome
Timeframe: 3 monthsNon hematologic treatment-related grade 4 toxicities measured according to CTCAE 3.0
Outcome measures
| Measure |
Ixabepilone/Cyclophosphamide
n=168 Participants
Systemic Therapy followed by surgery and possible radiation therapy
|
|---|---|
|
Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain
Fatigue
|
1 participants
|
|
Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain
Peripheral neuropathy
|
1 participants
|
|
Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain
Arthralgia/myalgia
|
1 participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: All patients who received a dose of study treatment.
Overall survival (OS) determined as the time between day 1 cycle 1 to the date of death from any cause. The percentage of patients who were alive at 3 years, estimated by Kaplan Meier method as the probability of being event free at 3 years is reported here.
Outcome measures
| Measure |
Ixabepilone/Cyclophosphamide
n=168 Participants
Systemic Therapy followed by surgery and possible radiation therapy
|
|---|---|
|
Overall Survival
|
90 percentage of participants
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: All patients who received a dose of study treatment.
Defined as the time between Day 1 Cycle 1, and date of first documented recurrence, initiation of additional chemotherapy, or death.
Outcome measures
| Measure |
Ixabepilone/Cyclophosphamide
n=168 Participants
Systemic Therapy followed by surgery and possible radiation therapy
|
|---|---|
|
Disease Free Survival
|
NA months
Median and 95% confidence interval were not estimable by Kaplan-Meier method due to insufficient observed events.
|
Adverse Events
Ixabepilone/Cyclophosphamide
Serious events: 6 serious events
Other events: 167 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone/Cyclophosphamide
n=168 participants at risk
All patients who received a dose of study treatment
|
|---|---|
|
Psychiatric disorders
DEPRESSION
|
0.60%
1/168 • Number of events 1
|
|
Gastrointestinal disorders
ENTERITIS
|
0.60%
1/168 • Number of events 1
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.8%
3/168 • Number of events 3
|
|
Nervous system disorders
PERIPHERAL NEUROPATHY
|
1.2%
2/168 • Number of events 2
|
Other adverse events
| Measure |
Ixabepilone/Cyclophosphamide
n=168 participants at risk
All patients who received a dose of study treatment
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.3%
14/168 • Number of events 29
|
|
Immune system disorders
ALLERGIC REACTION
|
6.0%
10/168 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
8.9%
15/168 • Number of events 38
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
59.5%
100/168 • Number of events 390
|
|
Blood and lymphatic system disorders
ANEMIA
|
70.2%
118/168 • Number of events 430
|
|
Metabolism and nutrition disorders
ANOREXIA
|
24.4%
41/168 • Number of events 92
|
|
Psychiatric disorders
ANXIETY
|
14.9%
25/168 • Number of events 79
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
51.8%
87/168 • Number of events 290
|
|
Musculoskeletal and connective tissue disorders
ASTHENIA
|
10.1%
17/168 • Number of events 30
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.7%
18/168 • Number of events 34
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
9.5%
16/168 • Number of events 26
|
|
Reproductive system and breast disorders
BREAST PAIN
|
8.9%
15/168 • Number of events 34
|
|
General disorders
CHEST PAIN
|
5.4%
9/168 • Number of events 16
|
|
Gastrointestinal disorders
CONSTIPATION
|
35.7%
60/168 • Number of events 175
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.8%
35/168 • Number of events 58
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.0%
10/168 • Number of events 12
|
|
Psychiatric disorders
DEPRESSION
|
10.1%
17/168 • Number of events 40
|
|
Gastrointestinal disorders
DIARRHEA
|
35.7%
60/168 • Number of events 127
|
|
Nervous system disorders
DIZZINESS
|
13.7%
23/168 • Number of events 41
|
|
Gastrointestinal disorders
DYSPEPSIA
|
19.0%
32/168 • Number of events 88
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
15.5%
26/168 • Number of events 39
|
|
General disorders
EDEMA
|
8.3%
14/168 • Number of events 32
|
|
General disorders
FATIGUE
|
81.0%
136/168 • Number of events 547
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
7.1%
12/168 • Number of events 15
|
|
General disorders
FEVER
|
9.5%
16/168 • Number of events 18
|
|
Nervous system disorders
HEADACHE
|
22.6%
38/168 • Number of events 95
|
|
Vascular disorders
HOT FLASHES
|
17.9%
30/168 • Number of events 79
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
8.3%
14/168 • Number of events 31
|
|
Vascular disorders
HYPERTENSION
|
7.7%
13/168 • Number of events 28
|
|
Infections and infestations
INFECTION
|
7.7%
13/168 • Number of events 18
|
|
Psychiatric disorders
INSOMNIA
|
28.6%
48/168 • Number of events 145
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
76.2%
128/168 • Number of events 457
|
|
Gastrointestinal disorders
MUCOSITIS
|
10.1%
17/168 • Number of events 31
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
32.7%
55/168 • Number of events 168
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
7.1%
12/168 • Number of events 27
|
|
Gastrointestinal disorders
NAUSEA
|
60.7%
102/168 • Number of events 297
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
75.6%
127/168 • Number of events 457
|
|
General disorders
PAIN
|
7.7%
13/168 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
23.8%
40/168 • Number of events 96
|
|
Nervous system disorders
PARESTHESIA
|
7.7%
13/168 • Number of events 34
|
|
Nervous system disorders
PERIPHERAL NEUROPATHY
|
69.6%
117/168 • Number of events 399
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.5%
11/168 • Number of events 22
|
|
General disorders
Pain
|
12.5%
21/168 • Number of events 37
|
|
Skin and subcutaneous tissue disorders
RASH
|
17.3%
29/168 • Number of events 53
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
6.0%
10/168 • Number of events 11
|
|
Nervous system disorders
TASTE ALTERATION
|
20.8%
35/168 • Number of events 122
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
33.3%
56/168 • Number of events 136
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY INFECTION
|
6.5%
11/168 • Number of events 16
|
|
Gastrointestinal disorders
VOMITING
|
19.0%
32/168 • Number of events 54
|
|
Investigations
WEIGHT LOSS
|
6.5%
11/168 • Number of events 22
|
Additional Information
John D. Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from the date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER