Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00404066
Recruitment Status : Completed
First Posted : November 27, 2006
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
GlaxoSmithKline
Sanofi
Information provided by (Responsible Party):
George Albert Fisher, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Metastatic Breast Cancer
Interventions Drug: Lapatinib
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Pegfilgrastim
Drug: Filgrastim
Drug: Dexamethasone
Drug: Trastuzumab
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neoadjuvant Chemotherapy
Hide Arm/Group Description Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
Period Title: Overall Study
Started 21 [1]
Completed 18
Not Completed 3
Reason Not Completed
Withdrawal by Subject - Pre-treatment             1
Withdrawal by Subject - Adverse event             2
[1]
1 subject started but withdrew after adriamycin+cytoxan, but before study drugs lapatinib+docetaxel.
Arm/Group Title Neoadjuvant Chemotherapy
Hide Arm/Group Description Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  90.5%
>=65 years
2
   9.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
21
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Hispanic or Latino
2
   9.5%
Not Hispanic or Latino
19
  90.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
8
  38.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
  61.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Ductal
21
 100.0%
Lobular
0
   0.0%
Tumor Size   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
T1 (≤ 20 mm at widest)
0
   0.0%
T2 (> 20 mm but ≤ 50 mm)
9
  42.9%
T3 (> 50 mm)
9
  42.9%
T4 (metastatic to chest wall / skin)
3
  14.3%
[1]
Measure Description:

Tumors were staged according to T stage:

  • T1: Malignancy is ≤ 20 millimeters (mm) at the widest spot
  • T2: Malignancy is > 20 mm but ≤ 50 mm
  • T3: Malignancy is > 50 mm
  • T4: Metastasized to chest wall and/or skin
Nodal involvement   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
N1 (few lymph nodes)
3
  14.3%
N2 (moderate number of lymph nodes)
13
  61.9%
N3 (many lymph nodes)
5
  23.8%
[1]
Measure Description:

Tumors were staged by lymph node involvement according to the following criteria.

  • N1: The cancer has spread to 1 to 3 axillary, or underarm, lymph nodes under the arm, and are ≥ 2 mm in size.
  • N2: The cancer has spread to 4 to 9 axillary lymph nodes, OR has spread to internal mammary lymph nodes
  • N3: The cancer has spread to ≥ 10 lymph nodes, OR has spread to both axillary and internal mammary lymph nodes
1.Primary Outcome
Title Percentage of Participants With Pathologic Complete Response (pCR)
Hide Description Pathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla, in participants who received at least 1 cycle of docetaxel and lapatinib and at least one follow-up evaluation.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neoadjuvant Chemotherapy
Hide Arm/Group Description:
Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
38.9
2.Secondary Outcome
Title Disease-free Survival (DFS)
Hide Description Disease-free survival (DFS) is expressed as the percentage of participants who were disease-free and alive at the time of analysis.
Time Frame 42 months (median follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
DFS is reported as the number and percentage of participants who were alive and disease-free at the time of analysis.
Arm/Group Title Neoadjuvant Chemotherapy
Hide Arm/Group Description:
Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
16
  88.9%
Time Frame up to 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neoadjuvant Chemotherapy
Hide Arm/Group Description Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
All-Cause Mortality
Neoadjuvant Chemotherapy
Affected / at Risk (%)
Total   2/21 (9.52%)    
Show Serious Adverse Events Hide Serious Adverse Events
Neoadjuvant Chemotherapy
Affected / at Risk (%) # Events
Total   0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neoadjuvant Chemotherapy
Affected / at Risk (%) # Events
Total   21/21 (100.00%)    
Blood and lymphatic system disorders   
Anemia *  17/21 (80.95%)  17
Gastrointestinal disorders   
Nausea *  14/21 (66.67%)  14
Diarrhea *  10/21 (47.62%)  10
Mucositis *  2/21 (9.52%)  2
General disorders   
Nail bed changes *  14/21 (66.67%)  14
Dysphagia (mouth pain) *  1/21 (4.76%)  1
Fatigue *  2/21 (9.52%)  2
Arthralgia (joint pain) *  1/21 (4.76%)  1
Pain, general *  1/21 (4.76%)  1
Metabolism and nutrition disorders   
Adrenal insufficiency *  1/21 (4.76%)  1
Nervous system disorders   
Peripheral neuropathy *  11/21 (52.38%)  11
Reproductive system and breast disorders   
Irregular menses *  20/21 (95.24%)  20
Skin and subcutaneous tissue disorders   
Hand-foot-skin reactions *  20/21 (95.24%)  20
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: George Albert Fisher, MD, PhD
Organization: Stanford University Medical Center
Phone: 650-725-9057
Responsible Party: George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier: NCT00404066     History of Changes
Other Study ID Numbers: IRB-03518
BRSADJ0002 ( Other Identifier: OnCore )
First Submitted: November 22, 2006
First Posted: November 27, 2006
Results First Submitted: February 3, 2017
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017