Trial Outcomes & Findings for Phase II Neoadjuvant in Inflammatory Breast Cancer (NCT NCT00756470)
NCT ID: NCT00756470
Last Updated: 2014-11-17
Results Overview
Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)
Results posted on
2014-11-17
Participant Flow
Recruitment Period: October 9, 2008 to December 30, 2011. All recruitment done at the University of Texas MD Anderson Cancer Center.
Study terminated early due to slow enrollment and review of futility.
Participant milestones
| Measure |
Neoadjuvant Lapatinib Plus Chemotherapy
Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil (5FU), Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Neoadjuvant Lapatinib Plus Chemotherapy
Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil (5FU), Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
4
|
Baseline Characteristics
Phase II Neoadjuvant in Inflammatory Breast Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Lapatinib Plus Chemotherapy
n=15 Participants
Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).
|
|---|---|
|
Age, Continuous
|
53.8 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
|
ECOG (Performance Status)
PS 0
|
13 participants
n=93 Participants
|
|
ECOG (Performance Status)
PS 1
|
2 participants
n=93 Participants
|
|
Clinical Stage: American Joint Committee on Cancer (AJCC) 2009
III B
|
3 participants
n=93 Participants
|
|
Clinical Stage: American Joint Committee on Cancer (AJCC) 2009
III C
|
8 participants
n=93 Participants
|
|
Clinical Stage: American Joint Committee on Cancer (AJCC) 2009
IV
|
4 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)Population: With an intent-to-treat population analysis, all participants who received any treatment were included in the analyses.
Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.
Outcome measures
| Measure |
Neoadjuvant Lapatinib Plus Chemotherapy
n=15 Participants
Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).
|
|---|---|
|
Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
|
6.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks)Population: While analyses was based on intent-to-treat (ITT) the surgical population includes only subjects who underwent definitive surgery (10 participants had a modified radical mastectomy) thus 5 were not evaluable for this outcome.
Pathologic complete response \[pCR or RCB Class 0\] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery.
Outcome measures
| Measure |
Neoadjuvant Lapatinib Plus Chemotherapy
n=10 Participants
Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).
|
|---|---|
|
Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)
RCB Class I
|
0 participants
|
|
Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)
RCB Class II
|
9 participants
|
|
Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)
RCB Class III
|
0 participants
|
|
Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)
RCB Class 0 (pCR)
|
1 participants
|
Adverse Events
Neoadjuvant Lapatinib Plus Chemotherapy
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant Lapatinib Plus Chemotherapy
n=15 participants at risk
Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
46.7%
7/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
3/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
6.7%
1/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
20.0%
3/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
General disorders
Fatigue
|
20.0%
3/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
Other adverse events
| Measure |
Neoadjuvant Lapatinib Plus Chemotherapy
n=15 participants at risk
Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
2/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
33.3%
5/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
Hepatobiliary disorders
Liver dysfunction
|
20.0%
3/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
Cardiac disorders
Decreased Ejection Fraction
|
6.7%
1/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
|
General disorders
Fatigue
|
46.7%
7/15 • Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
|
Additional Information
Ricardo Alvarez, MD/Breast Medical Oncology
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place