Trial Outcomes & Findings for Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer (NCT NCT00404066)
NCT ID: NCT00404066
Last Updated: 2017-12-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-12-22
Participant Flow
Participant milestones
| Measure |
Neoadjuvant Chemotherapy
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 Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Neoadjuvant Chemotherapy
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 Study
Withdrawal by Subject - Pre-treatment
|
1
|
|
Overall Study
Withdrawal by Subject - Adverse event
|
2
|
Baseline Characteristics
Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Chemotherapy
n=21 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 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
|
8 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
|
13 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
|
|
Histology
Ductal
|
21 Participants
n=93 Participants
|
|
Histology
Lobular
|
0 Participants
n=93 Participants
|
|
Tumor Size
T1 (≤ 20 mm at widest)
|
0 Participants
n=93 Participants
|
|
Tumor Size
T2 (> 20 mm but ≤ 50 mm)
|
9 Participants
n=93 Participants
|
|
Tumor Size
T3 (> 50 mm)
|
9 Participants
n=93 Participants
|
|
Tumor Size
T4 (metastatic to chest wall / skin)
|
3 Participants
n=93 Participants
|
|
Nodal involvement
N1 (few lymph nodes)
|
3 Participants
n=93 Participants
|
|
Nodal involvement
N2 (moderate number of lymph nodes)
|
13 Participants
n=93 Participants
|
|
Nodal involvement
N3 (many lymph nodes)
|
5 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPathologic 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.
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=18 Participants
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.
|
|---|---|
|
Percentage of Participants With Pathologic Complete Response (pCR)
|
38.9 percentage of participants
|
SECONDARY outcome
Timeframe: 42 months (median follow-up)Population: DFS is reported as the number and percentage of participants who were alive and disease-free at the time of analysis.
Disease-free survival (DFS) is expressed as the percentage of participants who were disease-free and alive at the time of analysis.
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=18 Participants
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.
|
|---|---|
|
Disease-free Survival (DFS)
|
16 Participants
|
Adverse Events
Neoadjuvant Chemotherapy
Serious events: 0 serious events
Other events: 21 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neoadjuvant Chemotherapy
n=21 participants at risk
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.
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|---|---|
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Reproductive system and breast disorders
Irregular menses
|
95.2%
20/21 • Number of events 20 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hand-foot-skin reactions
|
95.2%
20/21 • Number of events 20 • up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
66.7%
14/21 • Number of events 14 • up to 5 years
|
|
General disorders
Nail bed changes
|
66.7%
14/21 • Number of events 14 • up to 5 years
|
|
General disorders
Dysphagia (mouth pain)
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
General disorders
Fatigue
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Metabolism and nutrition disorders
Adrenal insufficiency
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Nervous system disorders
Peripheral neuropathy
|
52.4%
11/21 • Number of events 11 • up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
47.6%
10/21 • Number of events 10 • up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
81.0%
17/21 • Number of events 17 • up to 5 years
|
|
Gastrointestinal disorders
Mucositis
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
General disorders
Arthralgia (joint pain)
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
General disorders
Pain, general
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
Additional Information
George Albert Fisher, MD, PhD
Stanford University Medical Center
Phone: 650-725-9057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place