60 and older, any sex, with Breast Neoplasms or HER2/Neu Positive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent of Participants With Grade 3 or Higher Non-hematological Toxicities and Symptomatic Congestive Heart FailurePrimary· Until 30 days after last dose of treatment, an average of 8 months
Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 3 or higher toxicities attributed to lapatinib or trastuzumab.
Group
Value
95% CI
Age ≤75
17
6 – 35
Age >75
30
7 – 65
Percent of Participants With a Dose ModificationsSecondary· While on treatment, up to 4.5 years
Rates and associated 95% exact Clopper and Pearson binomial confidence intervals will be estimated.
A dose modification was defined as a hold (participant started the dose later than scheduled), reduction (subject was given a lower dose than originally scheduled), or discontinuation (subject stopped treatment) of lapatinib.
Group
Value
95% CI
Age ≤75
37
20 – 56
Age >75
60
26 – 88
Number of Participants With Tumor Response Using Response Evaluation Criteria in Solid Tumors (RECIST)Secondary· While on treatment, up to 4.5 years
RECIST:
Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis.
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions.
Stable D
Group
Value
95% CI
Age ≤75
0
Age >75
1
Age ≤75
7
Age >75
1
Age ≤75
6
Age >75
3
Age ≤75
12
Age >75
0
Median Progression-free Survival (PFS)Secondary· From the date treatment begins until the first date on which recurrence, progression or death due to any cause, with an average follow up of 1 year.
Median PFS and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated across all ages per protocol plan.
Progression is defined using RECIST v1.0, as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions.
Group
Value
95% CI
Lapatinib and Trastuzumab
2.7
2.5 – 12
Median Overall Survival (OS)Secondary· Time from start of treatment to death due to any cause, with average follow up of 4.5 years
OS will be estimated using the product limit method of Kaplan and Meier across all ages per protocol plan.
Group
Value
95% CI
Lapatinib and Trastuzumab
30.8
17.9 – 39.9
Adverse events — posted to ClinicalTrials.gov
Time frame: On treatment plus 30 days following discontinuation of treatment, up to 4.5 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies the side effects and how well lapatinib ditosylate and trastuzumab work in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other parts of the body (metastatic). Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or tumor cancer-killing substances to them. Giving lapatinib ditosylate together with trastuzumab may kill more tumor cells.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03784014 — Molecular Profiling of Advanced Soft-tissue Sarcomas
· Phase 3
· active not recruiting
NCT03523585 — DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
· Phase 3
· completed
NCT04185649 — The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
· Phase 3
· unknown
NCT03500380 — A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without L
· Phase 2, PHASE3
· unknown
NCT03084939 — Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2
· Phase 3
· completed
Other recruiting trials for Breast Neoplasms
Currently open trials in the same condition.
NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
· NA
· recruiting
NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models
· recruiting
NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic
· Phase 2
· recruiting
NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
· Phase 2
· recruiting
NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors
· NA
· recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
· Phase 2
· not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy
· Phase 2
· not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment
· Phase 1
· not yet recruiting
NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o
· NA
· withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 10 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01273610.