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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000264 |
Receipt No. | R000000332 |
Scientific Title | Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study |
Date of disclosure of the study information | 2005/10/15 |
Last modified on | 2010/04/15 |
Basic information | ||
Public title | Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study | |
Acronym | Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Beyond PD study) | |
Scientific Title | Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study | |
Scientific Title:Acronym | Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Beyond PD study) | |
Region |
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Condition | |||
Condition | Breast cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study is to evaluate the efficacy and safety of second Trastuzumab-containing regimen(Trastuzumab/Docetaxel combination therapy) in patients progressing on first line Trastuzumab monotherapy. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | response rate |
Key secondary outcomes | Progression-free survival(PFS)
Overall survival(OS) adverse event(AE) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Chemotherapy(Trastuzumab+Docetaxel) | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | Histologically confirmed mastocarcinoma
Patients progriising on first line Trastuzumab monotherapy HER2 status of primary or metastatic tumour was assessed positive Measurable or evaluable lesion ECOG performance status 0,1 or 2 Age: 20-75 years old Ample organ function Signed informed consent |
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Key exclusion criteria | Documented history of serious hypersensitivity reaction on the medical drugs
Severe complication Fever, suspicious of infection Severe pleural fluid and pericardial effusion Symptomatic brain metastasis Active double cancer Interstitial pneumonia or pulmonary fibrosis Neuropathy Grade 2,3 or 4 edema Pregnant or lactating women Doctor's decision for exclusion |
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Target sample size | 35 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka National Hospital | ||||||
Division name | Surgery(Breast Oncology) | ||||||
Zip code | |||||||
Address | 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka | ||||||
TEL | 06-6942-1331 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | H/D study group on Breast Cancer | ||||||
Division name | Executive Office | ||||||
Zip code | |||||||
Address | 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka | ||||||
TEL | 06-6942-1331 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | H/D study group on Breast Cancer |
Institute | |
Department |
Funding Source | |
Organization | H/D study group on Breast Cancer |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000332 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |