2024-09-18
minor
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v11
InterventionsAlbumin binding paclitaxel+ trastuzumab+ patuzumab (Drug), Docetaxel+ carboplatin+ trastuzumab + patuzumab (Drug)→Docetaxel+ carboplatin+ trastuzumab + patuzumab (Drug), Nab-paclitaxel+ trastuzumab+ patuzumab (Drug)
Eligibility criteria-130 characters
Inclusion Criteria:
Age: 18 years ≤ age ≤ -70 years, Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
Clinical T2-T4d, or T1c with axillary LN+lymph node positivity;
Histopathologically confirmed HER2 +-positive invasive breast cancer confirmed by histopathology; Note: HER2 expressionpositivity positivewas refersdetermined to the tumor cells withby immunohistochemical (IHC) staining intensity of 3+ or, confirmedif positiveIHC 2+, by HER2 gene amplification as demonstrated by fluorescence in situ hybridization [fish](FISH) atassay；
Have least once during the pathological detec [...] [...]
Secondary endpoints5 entries, revised
Event-freeFree survival rateSurvival (EFS)
Invasive Disease-freeFree survivalSurvival (DFSiDFS)
numberSafety-Number of adverse events and serious adverse events.
Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs
Exploratory endpoint - PCRDifferences in pCR rates forbetween eachpredefined subgroupsubgroups and factors affectinginfluencing pCR ofin the enrolledstudy population.
Study description+190 characters
In order to compare the effects of nab-PHP and TCBHPTCbHP chemotherapy regimens in the neoadjuvant treatment of HER2- [...] criteria into 2 groups through a randomized control regimen.
： the neoadjuvant chemotherapy with 6*nab-PHP regimen：Albumin bindinggroup (experimental group): nab-paclitaxel 125 mg 125mg/m2 (on days 1, 8, and 15 days) + trastuzumab (8 mg / kg for the first loading dose and 6 mg / kg for the sequential maintenance dose) + patuzumab (840mg for the first loading dose and 420mg for the sequential maintenance dose) ，every 21 days foras one cycle; 6 cycles.
*TCbHP regimen：Docetaxel (c [...] [...]
Study title-4 characters
ComparingA the EfficacyComparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Positive OperableEarly Breast Cancer
2024-04-12
minor
Study Status, Study Design v10
Primary completion date2023-12-31→2024-12-31
Completion date2023-12-31→2024-12-31
Enrollment target686→688
2023-12-19
minor
Study Status, Study Design, Outcome Measures, Eligibility v9
Eligibility criteria-1 characters
Inclusion Criteria:
18 years ≤ age ≤ 6570 years, Performance Status- Eastern Cooperative Oncology Gro [...] um pregnancy test was negative 14 days before randomization
KPSECOG score ≥of 800 pointsor 1
Signed the informed consent form prior to patient entry
Exc [...]
Secondary endpoints5 entries, revised
ObjectiveExploratory responseendpoint rate（ORR）- PCR rates for each subgroup and factors affecting pCR of the enrolled population
2023-12-14
minor
Study Status, Study Design, Outcome Measures v8
Secondary endpoints4 to 5 entries
Event-free survival rate (EFS)
Disease-free survival (DFS)
Objective response rate（ORR）
number of adverse events
Number ofand patients withserious adverse events.
ORR
DFSDose adjustment rate and withdrawal rate of chemotherapy drugs
2023-11-30
minor
Study Identification, Study Status v7
Re-verified, no change to tracked fields
Show 6 earlier versions
2023-03-15
minor
Study Status v6
Primary completion date2022-12-31→2023-12-31
Completion date2023-09→2023-12-31
2022-11-19
minor
Study Status, Sponsor/Collaborators v5
Primary completion date2022-09→2022-12-31
2022-07-18
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v4
Eligibility criteria+6 characters
Inclusion Criteria:
18 years ≤ age ≤ 7565 years, Performance Status- Eastern Cooperative Oncology Gro [...] form prior to patient entry
Exclusion Criteria:
Metastatic diseasebreast cancer (Stage IV)
Chemotherapy, endocrine therapy, targeted therap [...]
Secondary endpoints3 to 4 entries
OSnumber of adverse events
Number of patients with adverse events
Study description+978 characters
In order to compare the effects of nab-PHP and TCBHP chemotherapy regimens in the neoadjuvant treatment of HER2-positive breast cancer, this study randomly divided patients who met the inclusion criteria into 2 groups through a randomized control regimen.
nab-PHP regimen：Albumin binding paclitaxel 1 [...]
Study title-53 characters
Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2 Positive Operable Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial
2020-09-17
minor
Study Status v3
Start dateestimated 2020-09-09→confirmed 2020-09-18
2020-09-15
minor
Study Identification, Study Status v2
Study title+7 characters
Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2 Positive Operable Breast Cancer With HER2 Positive, A Multicenter, Randomized, Phase III Clinical Trial
2020-09-13
minor
Study Status, Sponsor/Collaborators v1
Re-verified, no change to tracked fields
2020-09-08
minor
Original filing