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Phase II Neoadjuvant in Inflammatory Breast Cancer

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ClinicalTrials.gov Identifier: NCT00756470
Recruitment Status : Terminated (Slow accrual.)
First Posted : September 22, 2008
Results First Posted : November 5, 2014
Last Update Posted : November 17, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Lapatinib
Drug: Paclitaxel
Drug: 5-Fluorouracil (5-FU)
Drug: Epirubicin
Drug: Cyclophosphamide
Enrollment 15

Recruitment Details Recruitment Period: October 9, 2008 to December 30, 2011. All recruitment done at the University of Texas MD Anderson Cancer Center.
Pre-assignment Details Study terminated early due to slow enrollment and review of futility.
Arm/Group Title Neoadjuvant Lapatinib Plus Chemotherapy
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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).
Period Title: Overall Study
Started 15
Completed 10
Not Completed 5
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             4
Arm/Group Title Neoadjuvant Lapatinib Plus Chemotherapy
Hide Arm/Group Description

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).
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
53.8
(39 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
1
   6.7%
Not Hispanic or Latino
14
  93.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
  93.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
ECOG (Performance Status)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants
PS 0 13
PS 1 2
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) performance status (PS) performed at baseline. PS described as 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; etc.
Clinical Stage: American Joint Committee on Cancer (AJCC) 2009   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants
III B 3
III C 8
IV 4
[1]
Measure Description: AJCC Breast cancer staging: Anatomic stage 0, IA or B, IIA or B, IIIA to C or IV. AJCC staging system provides strategy for grouping participants by prognosis, based on the extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M). Once the T, N, and M are determined, they are combined , and an overall stage of 0, I, II, III, IV is assigned from least advanced to more advanced. Sometimes these stages are subdivided as well, using letters such as IIIA and IIIB.
1.Primary Outcome
Title Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
Hide Description 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.
Time Frame Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With an intent-to-treat population analysis, all participants who received any treatment were included in the analyses.
Arm/Group Title Neoadjuvant Lapatinib Plus Chemotherapy
Hide Arm/Group Description:

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).
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Percentage of Participants
6.6
2.Secondary Outcome
Title Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)
Hide Description 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.
Time Frame Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neoadjuvant Lapatinib Plus Chemotherapy
Hide Arm/Group Description:

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).
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
RCB Class 0 (pCR) 1
RCB Class I 0
RCB Class II 9
RCB Class III 0
Time Frame Adverse event collection approximately 26 weeks following the start of neoadjuvant chemotherapy. Overall study period: October 2008 to September 2013.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neoadjuvant Lapatinib Plus Chemotherapy
Hide Arm/Group Description

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).
All-Cause Mortality
Neoadjuvant Lapatinib Plus Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Neoadjuvant Lapatinib Plus Chemotherapy
Affected / at Risk (%)
Total   7/15 (46.67%) 
Blood and lymphatic system disorders   
Neutropenia  1 [1]  3/15 (20.00%) 
Neutropenic Fever  1 [1]  1/15 (6.67%) 
Gastrointestinal disorders   
Diarrhea  1 [1]  7/15 (46.67%) 
General disorders   
Fatigue  1 [1]  3/15 (20.00%) 
Skin and subcutaneous tissue disorders   
Skin Rash  1 [1]  3/15 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade 3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Neoadjuvant Lapatinib Plus Chemotherapy
Affected / at Risk (%)
Total   15/15 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1 [1]  2/15 (13.33%) 
Neutropenia  1 [1]  2/15 (13.33%) 
Cardiac disorders   
Decreased Ejection Fraction  1 [1]  1/15 (6.67%) 
Gastrointestinal disorders   
Diarrhea  1 [1]  1/15 (6.67%) 
General disorders   
Fatigue  1 [1]  7/15 (46.67%) 
Hepatobiliary disorders   
Liver dysfunction  1 [1]  3/15 (20.00%) 
Skin and subcutaneous tissue disorders   
Skin Rash  1 [1]  5/15 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade 2
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ricardo Alvarez, MD/Breast Medical Oncology
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2817
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00756470     History of Changes
Other Study ID Numbers: 2007-0818
First Submitted: September 19, 2008
First Posted: September 22, 2008
Results First Submitted: October 30, 2014
Results First Posted: November 5, 2014
Last Update Posted: November 17, 2014