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This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab given as neoadjuvant treatment in HER2 positive early-stage or locally advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NHP | Experimental | Navelbine, Herceptin, Pertuzumab |
|
| THP | Active Comparator | Docetaxel, Herceptin, Pertuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navelbine | Drug | Navelbine 25mg/m2 on day 1 and 8, every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pCR | Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Disease-free Survival | Following surgery until Year 3 |
| DDFS | Distance Disease-free Survival | Following surgery until Year 3 |
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Inclusion Criteria:
Female patients, 18 years ≤ age ≤ 80 years; Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 Histologically confirmed invasive breast cancer(early stage or locally advanced) HER2 positive (HER2+++ by IHC or FISH+) Known hormone receptor status. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO Signed informed consent form (ICF)
Exclusion Criteria:
Metastatic disease (Stage IV) or inflammatory breast cancer Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.
Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); Unable or unwilling to swallow tablets.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| Docetaxel |
| Drug |
Docetaxel 90mg/m2 on day 1, every 3 weeks |
|
| ORR | Objective Response Rate | Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |