UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer
Acronym	KBCSG-TR1213
Scientific Title	A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer
Scientific Title:Acronym	KBCSG-TR1213
Region	Japan

Condition
Condition	HER2 negative operable breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of preoperative administration of Tri-weekly nanoparticle albumin-bound paclitaxel (nab-Paclitaxel) of 4 cycles followed by FEC of 4 cycles in patients with HER2 negative operable breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Pathological complete response rate
Key secondary outcomes	(1) Safety (adverse events, incidence of cardiac disorders) (2) Overall response rate (3) Breast conserving rate (4) QpCR rate (5) CpCR and pN0 rate (6) SpCR rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administrate 4 cycles of FEC after 4 cycles of nab-Paclitaxel. Operation is to be performed after chemotherapy. nab-Paclitaxel 4 cycles nab-Paclitaxel 260mg/m2 iv day1 q3w FEC 4 cycles 5-Fluorouracil 500mg/m2 iv day 1 q3w Epirubicin 100mg/m2 iv day 1 q3w Cyclophosphamide 500mg/m2 iv day 1 q3w
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Female
Key inclusion criteria	1) Primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy. 2) T1c-3, N0-1, M0 and tumor size is less than 7 cm. 3) Invasive lesion of the primary lesion is confirmed as HER2 negative (IHC 0-1+ or, if IHC 2+ -> FISH negative). 4) Enrollmental age between 20 years old and 65 years old. 5) ECOG performance status (PS):0-1 6) Results from a laboratory test meet the following : - Neutrophil count is >= 1,500/mm3 - Platelet >= 100,000/mm3 - Hemoglobin >= 10.0 g/dL - AST <= 3 times of upper limit of normal (ULN) - ALT <= 3 times of upper limit of normal (ULN) - Total bilirubin < 1.5 mg/dL - Creatinine < 1.5 mg/dL 7) No clinical abnormality by electrocardiography. 8) No interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan. 9) Evaluate images of the primary lesion before and after treatment by CT, MRI. The evaluation must be conducted by the same modality (At an allergy for contrast media, the omission is permissible). 10) No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy. 11) Considered eligible to neoadjuvant chemotherapy based on decision of the attending physician after considering other treatments such as surgery, chemotherapy, hormone therapy, radiation therapy. 12) Urinary or serum HCG negative when menopause is not confirmed (excluding patients underwent ovariectomy or hysterectomy). 13) Signed written informed consent.
Key exclusion criteria	1) Hypersensitivity to any agents necessary in the planned treatment. 2) Poorly controlled complication. 3) Active infectious disease or Fever with suspected infection. 4) Symptoms of varicella. 5) Serious edema. 6) Serious peripheral neuropathy. 7) Positive for HBs antigen. 8) Complication which requires prior pre-treatment with corticosteroid. 9) Previous history or receiving treatment of dementia or serious psychiatric disorder. 10) Heterochrony or synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 11) Active multiple cancer (Non-invasive tumor or disease free periods after treatment are more than two years, considered to be non-activity). 12) Prior treatment with anticancer agents. 13) Ineligible based on decision of an investigator.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Norikazu Masuda
Organization	Osaka National Hospital
Division name	Department of Surgery (mastology)
Zip code
Address	1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL	0669421331
Email	nmasuda@alpha.ocn.ne.jp

Public contact
1st name of contact person	1st name Middle name Last name Norikazu Masuda
Organization	Kinki Breast Cancer Study Group-Translational Research (KBCSG-TR)
Division name	Adminstrative office
Zip code
Address	1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL	06-6942-1331
Homepage URL
Email	nmasuda@alpha.ocn.ne.jp

Sponsor
Institute	Kinki Breast Cancer Study Group-Translational Research (KBCSG-TR)
Institute
Department

Funding Source
Organization	The Supporting Center for Clinical Research and Education (SCCRE)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	None

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2012 Year 06 Month 01 Day

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	2012 Year 03 Month 20 Day
Date of IRB	2012 Year 05 Month 31 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 06 Month 01 Day
Last modified on	2019 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009512