Trial Outcomes & Findings for Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer (NCT NCT01036087)
NCT ID: NCT01036087
Last Updated: 2023-03-30
Results Overview
Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).
Results posted on
2023-03-30
Participant Flow
Recruitment Period: November 2010- July 2015. All recruitment was done at The University of Texas MD Anderson Cancer Center.
47 participants were accrued and assessed for eligibility. 7 participants were ineligible and excluded ( 3 had HER2-positive disease, 2 had metastatic disease, and 2 did not receive financial approval for treatment.
Participant milestones
| Measure |
PNC + FEC
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
PNC + FEC
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
Baseline characteristics by cohort
| Measure |
PNC + FEC
n=40 Participants
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
|
|---|---|
|
Nuclear Grade
Grade 3
|
27 Participants
n=5 Participants
|
|
Primary Tumor Subtype
HR Positive HER2 negative
|
21 Participants
n=5 Participants
|
|
Primary Tumor Subtype
HR Negative HER2 negative
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
11 Participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
29 Participants
n=5 Participants
|
|
Clinical N Category
N1
|
20 Participants
n=5 Participants
|
|
Clinical N Category
N2
|
4 Participants
n=5 Participants
|
|
Clinical N Category
N3
|
16 Participants
n=5 Participants
|
|
Clinical TNM Stage at Presentation
III
|
36 Participants
n=5 Participants
|
|
Clinical TNM Stage at Presentation
IV
|
4 Participants
n=5 Participants
|
|
Nuclear Grade
Grade 2
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field.
Outcome measures
| Measure |
PNC + FEC
n=40 Participants
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
|
|---|---|
|
Number of Participants That Achieved Pathologic Complete Response (CR)
|
11 Participants
|
SECONDARY outcome
Timeframe: Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent.AEs were graded according to the National Cancer Institute's Common Terminology Criteria (CTCAE), version 3.0. All AEs (\>/=2 non-hematological and \>/=3 hematological AEs) occurring after informed consent signing observed by the investigator or reported by the subject whether or not attributed to investigational product. Full AE reporting can be found in the Adverse Event Section.
Outcome measures
| Measure |
PNC + FEC
n=40 Participants
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events (AEs)
>/=2 non-hematological AEs
|
36 Participants
|
|
Number of Participants With Treatment-related Adverse Events (AEs)
>/=3 hematological AEs
|
26 Participants
|
Adverse Events
PNC + FEC
Serious events: 15 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PNC + FEC
n=40 participants at risk
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
|
|---|---|
|
Gastrointestinal disorders
Bleeding per rectum
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
General disorders
Delirium
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Gastrointestinal disorders
Epigastric pain
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Renal and urinary disorders
Kidney stone
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Blood and lymphatic system disorders
MDS
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
5/40 • Number of events 5 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Nervous system disorders
Sycope
|
5.0%
2/40 • Number of events 2 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Vascular disorders
Thrombosis
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Infections and infestations
Vulvar abscess
|
2.5%
1/40 • Number of events 1 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
Other adverse events
| Measure |
PNC + FEC
n=40 participants at risk
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
22.5%
9/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
65.0%
26/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
17.5%
7/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
20.0%
8/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
6/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
17.5%
7/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
16/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
5/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
8/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
82.5%
33/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.5%
3/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
57.5%
23/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
2/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
General disorders
Fatigue
|
57.5%
23/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
General disorders
Hypersensitivity
|
5.0%
2/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Nervous system disorders
Hand-and-foot syndrome
|
10.0%
4/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.5%
7/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Infections and infestations
Infection
|
17.5%
7/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.0%
2/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
6/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Renal and urinary disorders
Urinary tract infection
|
10.0%
4/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
|
Investigations
Weight loss
|
5.0%
2/40 • Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
|
Additional Information
Dr. Naoto Ueno, Professor, Breast Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 792-8754
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place