Trial Outcomes & Findings for Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients (NCT NCT00841828)

Last Updated: 2023-03-31

Results Overview

Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller\&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

Up to 16 weeks

Results posted on

2023-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: EC -> D + Lapatinib EC -\> D + Lapatinib Drugs plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -\> Docetaxel + Lapatinib each 21 days for 4 cycles	Arm 2: EC -> D + Trastuzumab EC -\> D + Trastuzumab Drug plus Biological EC each 21 days for 4 cycles -\> Docetaxel + Trastuzumab each 21 days for 4 cycles
Overall Study STARTED	52	50
Overall Study COMPLETED	42	48
Overall Study NOT COMPLETED	10	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: EC -> D + Lapatinib n=52 Participants Epirubicin and Cyclophosphamide (EC) followed by Docetaxel (D) and Lapatinib Drugs plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles followed by Docetaxel and Lapatinib each 21 days for 4 cycles	Arm 2: EC -> D + Trastuzumab n=50 Participants Epirubicin and Cyclophosphamide (EC) followed by Docetaxel (D) and Trastuzumab Drug plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles followed by Docetaxel and Trastuzumab each 21 days for 4 cycles	Total n=102 Participants Total of all reporting groups
Age, Continuous	48 years n=5 Participants	48.5 years n=7 Participants	48 years n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	50 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Spain	52 participants n=5 Participants	50 participants n=7 Participants	102 participants n=5 Participants
Menopausal Status Premenopausal	28 participants n=5 Participants	29 participants n=7 Participants	57 participants n=5 Participants
Menopausal Status Postmenopausal	24 participants n=5 Participants	21 participants n=7 Participants	45 participants n=5 Participants
Estrogen Receptor Positive	29 participants n=5 Participants	30 participants n=7 Participants	59 participants n=5 Participants
Estrogen Receptor Negative	23 participants n=5 Participants	20 participants n=7 Participants	43 participants n=5 Participants
Tumor Size	3.5 centimeters n=5 Participants	3.3 centimeters n=7 Participants	3.3 centimeters n=5 Participants
Nodal Status N0=no regional lymph node metastases	19 participants n=5 Participants	13 participants n=7 Participants	32 participants n=5 Participants
Nodal Status N1=metastases 1-3 axillary lymph node/s	32 participants n=5 Participants	35 participants n=7 Participants	67 participants n=5 Participants
Nodal Status N2=metastases in 4-9 axillary lymph nodes	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 16 weeks

Population: Arm 1: 1 patient not included in this analysis due to negative Fluorescence in situ hybridization (FISH) result. Arm 2: 2 patients not included in this analysis due to negative Fluorescence in situ hybridization (FISH) result.

Outcome measures

Outcome measures
Measure	Arm 1: EC -> D + Lapatinib n=51 Participants EC -\> D + Lapatinib Drugs plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -\> Docetaxel (D) + lapatinib each 21 days for 4 cycles)	Arm 2: EC -> D + Trastuzumab n=48 Participants EC -\> D + Trastuzumab Drug plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -\> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles
Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).	23.5 percentage of participants with pCR Interval 11.9 to 35.1	47.9 percentage of participants with pCR Interval 33.8 to 62.0

SECONDARY outcome

Timeframe: Up to 12 weeks

Overall clinical response was evaluated according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria (Therasse et al, 2000). Is defined as the sum of Complete responses plus Partial responses. It was evaluated after the fourth EC cycle and before surgery using ultrasound, mammography, or MRI.

Outcome measures

Outcome measures
Measure	Arm 1: EC -> D + Lapatinib n=51 Participants EC -\> D + Lapatinib Drugs plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -\> Docetaxel (D) + lapatinib each 21 days for 4 cycles)	Arm 2: EC -> D + Trastuzumab n=48 Participants EC -\> D + Trastuzumab Drug plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -\> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles
Overall Clinical Response Rate (ORR)	62.7 percentage of participants Interval 49.4 to 76.0	77.1 percentage of participants Interval 65.2 to 89.0

Adverse Events

Arm 1: EC -> D + Lapatinib

Serious events: 11 serious events

Other events: 28 other events

Deaths: 0 deaths

Arm 2: EC -> D + Trastuzumab

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: EC -> D + Lapatinib n=52 participants at risk EC -\> D + Lapatinib Drugs plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -\> Docetaxel (D) + lapatinib each 21 days for 4 cycles)	Arm 2: EC -> D + Trastuzumab n=50 participants at risk EC -\> D + Trastuzumab Drug plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -\> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles
Gastrointestinal disorders Diarrhea	3.8% 2/52 • Number of events 2 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	0.00% 0/50 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Blood and lymphatic system disorders Neutrophils/granulocytes	5.8% 3/52 • Number of events 3 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	2.0% 1/50 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Infections and infestations Infection	3.8% 2/52 • Number of events 2 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	2.0% 1/50 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Infections and infestations Febrile Neutropenia	1.9% 1/52 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	2.0% 1/50 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Gastrointestinal disorders Mucositis	1.9% 1/52 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	0.00% 0/50 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.9% 1/52 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	0.00% 0/50 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
General disorders Fever	1.9% 1/52 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	2.0% 1/50 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.

Other adverse events

Other adverse events
Measure	Arm 1: EC -> D + Lapatinib n=52 participants at risk EC -\> D + Lapatinib Drugs plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -\> Docetaxel (D) + lapatinib each 21 days for 4 cycles)	Arm 2: EC -> D + Trastuzumab n=50 participants at risk EC -\> D + Trastuzumab Drug plus Biological Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -\> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles
Blood and lymphatic system disorders Leukocytes (total WBC)	19.2% 10/52 • Number of events 10 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	10.0% 5/50 • Number of events 5 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Blood and lymphatic system disorders Lymphopenia	11.5% 6/52 • Number of events 6 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	2.0% 1/50 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Blood and lymphatic system disorders Neutropenia	25.0% 13/52 • Number of events 13 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	20.0% 10/50 • Number of events 10 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Skin and subcutaneous tissue disorders Rash/desquamation	7.7% 4/52 • Number of events 4 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	0.00% 0/50 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Gastrointestinal disorders Diarrhea	13.5% 7/52 • Number of events 7 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	2.0% 1/50 • Number of events 1 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Gastrointestinal disorders Nausea and Vomiting	5.8% 3/52 • Number of events 3 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	0.00% 0/50 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Metabolism and nutrition disorders ALT, SGPT	0.00% 0/52 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	6.0% 3/50 • Number of events 3 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
Infections and infestations Infection	3.8% 2/52 • Number of events 2 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	0.00% 0/50 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.
General disorders Fatigue	3.8% 2/52 • Number of events 2 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.	12.0% 6/50 • Number of events 6 • Through study treatment up to 24 week These Adverse Events are by patient (not per cycle). Only grades 3 and 4 are specified.

Additional Information

Dr. Emilio Alba

Department of Medical Oncology, Hospital Universitario Virgen de la Victoria

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place