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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: October 9, 2008 to December 30, 2011. All recruitment done at the University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study terminated early due to slow enrollment and review of futility.

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Neoadjuvant Lapatinib Plus Chemotherapy
STARTED   15 
COMPLETED   10 
NOT COMPLETED   5 
Withdrawal by Subject                1 
Adverse Event                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Neoadjuvant Lapatinib Plus Chemotherapy

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).

Baseline Measures
   Neoadjuvant Lapatinib Plus Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Median (Full Range)
 53.8 
 (39 to 70) 
Gender 
[Units: Participants]
 
Female   15 
Male   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   1 
Not Hispanic or Latino   14 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   14 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   15 
ECOG (Performance Status) [1] 
[Units: Participants]
 
PS 0   13 
PS 1   2 
[1] 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] 
[Units: Participants]
 
III B   3 
III C   8 
IV   4 
[1] 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.


  Outcome Measures

1.  Primary:   Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy   [ Time Frame: Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks) ]

2.  Secondary:   Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)   [ Time Frame: Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: CR_Study_Registration@mdanderson.org



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