18 and older, any sex, with Breast Cancer. 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.
Objective Response RatePrimary· 8 weeks
The objective response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response recorded on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria.
CR and PR must meet the following lesion criteria without having any new lesions as well:
Target Lesion:
(CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
(PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as refere
Group
Value
95% CI
Cohort 1
50.0
33.8 – 66.2
Cohort 2
22.2
11.3 – 37.3
Top 3 Most Common Treatment RelatedToxicitiesSecondary· Up to 93 months
Assessed by -Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Top 3 treatment-related all-grade adverse events in terms of incidence.
Treatment Related is discerned as follows:
Yes: There is a plausible temporal relationship between the onset of the AE and administration of atezolizumab or bevacizumab, and the AE cannot be readily explained by the patient's clinical state, intercurrent illness, or concomitant therapies; and/or the AE follows a known pattern of response to atezolizumab or bevacizumab or with similar treatments; and/or the AE resolves upon discontinuation of
Diarrhea
Group
Value
95% CI
Cohort 1
27
Cohort 2
28
Fatigue
Group
Value
95% CI
Cohort 1
21
Cohort 2
24
Acne
Group
Value
95% CI
Cohort 1
20
Cohort 2
15
Sites of First ProgressionSecondary· Up to 93 months
Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST) as follows:
\- \>20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including baseline if it's the smallest). The sum must also demonstrate an increase of \>5 mm.
OR
-Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study
Central Nervous System (CNS)
Group
Value
95% CI
Cohort 1
3
Cohort 2
3
Non-CNS
Group
Value
95% CI
Cohort 1
31
Cohort 2
39
CNS and Non-CNS
Group
Value
95% CI
Cohort 1
3
Cohort 2
0
NA
Group
Value
95% CI
Cohort 1
4
Cohort 2
4
Clinical Benefit RateSecondary· Up to 93 months
Clinical Benefit Rate is the percentage of participants who achieve clinical benefit from the study treatment. Clinical benefit is defined as at least 24 weeks of confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
SD or better is achieved if the following are true:
Target Lesions:
-At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a
Group
Value
95% CI
Cohort 1
57.5
40.9 – 73
Cohort 2
40.0
25.7 – 55.7
3-Year Overall SurvivalSecondary· Up to 93 months
Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. 3-Year survival is calculated using Kaplan-Meier methods.
Group
Value
95% CI
Cohort 1
.62
.47 – .81
Cohort 2
.39
.26 – .57
Median Time to ProgressionSecondary· Up to 93 months
Time to progression (TTP) is defined as the time from study entry to disease progression by RECIST. Subjects are considered to have progressed if they discontinue treatment due to clinical deterioration from breast cancer or die on-treatment of any cause. TTP is censored at the time of initiation of alternative therapy or time of last contact. The time to progression is calculated using a Kaplan-Meier emthods.
Progression is defined by RECIST as:
\>20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including baseline if it's the smalles
Group
Value
95% CI
Cohort 1
7.4
3.9 – 9.3
Cohort 2
5.3
3.7 – 6.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 93 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1
Serious: 2/41 (5%)
Deaths: 15/41
Cohort 2
Serious: 7/46 (15%)
Deaths: 34/46
Serious adverse events (5 terms)
Reaction
System
Cohort 1
Cohort 2
Diarrhea w/o prior colostomy
Gastrointestinal disorders
—
—
Fatigue
General disorders
—
—
Diarrhea w/o prior colostomy
Gastrointestinal disorders
—
—
Hypokalemia
Metabolism and nutrition disorders
—
—
GI-other
Gastrointestinal disorders
—
—
Other adverse events (155 terms — click to expand)
In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.
Publications & conference data
6 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 Cancer
Currently open trials in the same condition.
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· Phase 1
· recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R
· Phase 2
· recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
· Phase 2
· recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
· NA
· recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer
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· 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 Nancy Lin, MD
Last refreshed: 19 December 2024
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/NCT00470704.