UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012909
Receipt number R000014639
Scientific Title A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer
Date of disclosure of the study information 2014/01/21
Last modified on 2019/03/22 16:21:05

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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

A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer(KBCSG-TR1315)

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

A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer(KBCSG-TR1315)

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

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(260mg/m2) intravenously on day 1 of each 3-weeks.

FEC(5-Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) intravenously on day 1 of each 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

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) Evaluate images of the primary lesion before and after treatment by ultrasonic diagnosis. The evaluation must be conducted by the same modality
11) No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy.
12) Considered eligible to neoadjuvant chemotherapy based on decision of the attending physician after considering other treatments such as surgery, chemotherapy, hormone therapy, radiation therapy.
13) Urinary or serum HCG negative when menopause is not confirmed (excluding patients underwent ovariectomy or hysterectomy).
14) 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, except for not under the appropriate antiviral medication
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) Treatment with anticancer agent within five years.
13) Ineligible based on decision of an investigator.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Norikazu
Middle name
Last name Masuda

Organization

Osaka National Hospital

Division name

Department of Surgery, Breast Surgery

Zip code

540-0006

Address

1-14, 2-chome Hoenzaka, Chuo-ku, Osaka-city, Osaka, Japan

TEL

06-6942-1331

Email

nmasuda@alpha.ocn.ne.jp


Public contact

Name of contact person

1st name Takahiro
Middle name
Last name Nakayama

Organization

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

Division name

Adminstrative office

Zip code

541-8567

Address

3-1-69, Otemachi, chuou-ku, Osaka-city, Osaka, Japan

TEL

06-6945-1181

Homepage URL


Email

taqnakayama@hotmail.com


Sponsor or person

Institute

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

Institute

Department

Personal name



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



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

2014 Year 01 Month 21 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

2013 Year 10 Month 17 Day

Date of IRB

2014 Year 01 Month 20 Day

Anticipated trial start date

2014 Year 01 Month 21 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 21 Day

Last modified on

2019 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014639


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name