UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
Title of the study (Brief title)	Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy (CYBORG-002)
Region	Japan

Condition
Condition	HER2-Positive Metastatic Breast Cancer
Classification by specialty	Breast surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to assess the efficacy and the safety of pertuzumab plus trastuzumab plus docetaxel for HER2 positive metastatic breast cancer that progressed during prior trastuzumab therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Objective response rate
Key secondary outcomes	Progression free survival Clinical benefit rate Overall survival Safety

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	Medicine
Interventions/Control_1	Administration of Pertuzumab and Trastuzumab with a starting dose of 840 mg and 8 mg/kg followed by 420 mg and 6 mg/kg as the second and subsequent doses and Docetaxel with a dose of 60-75 mg/m2 every 3 weeks.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. Patients who are 18 years or older with breast cancer which is confirmed to be invasive breast cancer by histological examination 2. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods 3. ECOG performance status(PS) is 0, 1 or 2 4. Patients with measurable lesions by Response Evaluation Criteria In Solid Tumors (RECIST) 5. The number of prior trastuzumab therapy is within 3 regimen. 6. Major organ function is maintained. 7. Left-ventricular ejection fraction (LVEF) is at least 50% at baseline. 8. Signed informed consent was obtained from patient.
Key exclusion criteria	1. Patients who have an active infection or high fever with suspicious infection. 2. Patients who have a history of cardiac disease, including known symptomatic decreases in LVEF to less than 50% absolute value during prior trastuzumab therapy or congestive heart failure. 3. Patients with pulmonary fibrosis or interstitial pneumonia that is clear from the chest X-ray 4. Patients with previous exposure to a cumulative dose of doxorubicin of more than 360 mg/m2 5. Patients with a decline in LVEF to less than 50% during or after former trastuzumab treatment 6. Patients suspected of being pregnant or pregnant women 7. Patients with another malignancy within the last 5 years 8. Patients with uncontrollable brain metastases 9. Patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Target sample size	35

Research contact person
Name of lead principal investigator	Shin Takayama
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Department of Surgery
Address	5-11-13 Sugano, Ichikawa-shi, Chiba, JAPAN
TEL	047-322-0151
Email	stakayama@tdc.ac.jp

Public contact
Name of contact person	Mutsumi Ishi
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Department of Pharmacy
Address	5-11-13 Sugano, Ichikawa-shi, Chiba, JAPAN
TEL	047-322-0151
Homepage URL
Email	mishii@tdc.ac.jp

Sponsor
Institute	Chiba Youth Breast Oncology Research Group (CYBORG)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	1)亀田総合病院（千葉県） 2)東京歯科大学市川総合病院（千葉県） 3)千葉県がんセンター（千葉県） 4)千葉大学医学部付属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 02 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 02 Day
Anticipated trial start date	2013 Year 11 Month 26 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 01 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014567